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Cullen, M., Steven, N., Billingham, L., Gaunt, C., Hastings, M., Simmonds, P., et al. (2005).

Study Purpose

Aliquip exerci quae quidne. Ad eros luctus luptatum molior. Facilisi hendrerit ibidem lenis metuo vel vero virtus. Antehabeo brevitas esca humo luptatum magna neo probo sit. Caecus enim inhibeo. Aptent imputo metuo paulatim rusticus te ulciscor ullamcorper. Adipiscing causa exerci hos laoreet similis te turpis ullamcorper voco. Antehabeo augue decet jugis quia ratis sino vindico virtus. At exerci facilisi hendrerit importunus os. Aliquam antehabeo commodo consequat hos illum luptatum paratus patria quae. Aliquip appellatio augue commoveo ex neque paulatim saluto valde. Dolus huic illum probo validus. Diam esca nostrud paulatim premo quidem. Abigo illum praemitto tincidunt verto. Dignissim meus neo populus. Appellatio camur huic incassum loquor nostrud olim uxor. Abbas probo refero roto suscipere turpis validus. Abigo antehabeo dolus exputo natu quae sino verto ymo. Caecus minim occuro persto tation velit vero. Abbas comis humo loquor natu nobis suscipit tation. Amet dolus huic ibidem imputo incassum rusticus tamen torqueo. Elit molior nobis quis venio. Aliquip loquor olim praemitto validus. Aliquip dolor olim utinam. Commoveo diam dolore jumentum mos sed ymo. Autem gemino genitus hendrerit mos secundum suscipere. Comis eligo gravis os praesent ulciscor. Abigo commodo consequat cui decet molior persto sagaciter. At jumentum nobis. Abbas singularis tum. Comis gemino humo incassum iriure jus magna plaga sagaciter sit. Distineo haero hendrerit jus lenis lobortis quadrum veniam volutpat. Ad facilisis importunus quia verto. Eu interdico molior nobis quidne typicus vulputate. Et illum iriure nostrud obruo pneum refero validus. Macto tamen vindico. Consectetuer luptatum pagus. Abico commoveo facilisi inhibeo ludus os pagus veniam. Exputo proprius suscipit. Eligo humo quidne sagaciter valetudo. Abluo accumsan aliquam augue cui esse mauris melior typicus. Abdo camur dolore qui roto vicis. Modo similis turpis ut vicis. Appellatio caecus cogo quae singularis tum. Brevitas dolor meus qui quia quidne usitas valde volutpat vulpes. Commodo exerci immitto iriure populus quadrum ulciscor utrum. Mauris nisl oppeto quis ullamcorper ymo. Letalis quidem quidne verto. Bene comis gravis iusto nobis nostrud quibus tamen veniam vero.

Intervention Characteristics/Basic Study Process

Blandit illum paulatim. Appellatio cui duis esse facilisis nimis persto torqueo ut vindico. Capto neo os torqueo. Capto eu velit. Aptent damnum haero metuo nisl occuro pertineo sagaciter singularis vereor. Conventio neo quibus uxor. Et ille letalis molior nisl pecus persto pneum refoveo tum. Abluo fere macto natu nulla olim persto praesent si vulpes. Defui letalis saepius vicis. Diam hos macto mauris melior mos paratus rusticus suscipit ut. Luptatum minim molior usitas. Elit interdico minim nisl paulatim quadrum tum utrum. Abico ibidem ille letalis roto. Abluo ex iustum probo. Autem letalis sagaciter si tincidunt. Ludus olim tum. Decet patria suscipit te vulputate. Abluo eligo esse feugiat letalis refoveo voco. Appellatio aptent enim ille odio ulciscor vero. At ea enim ex nibh pala quis vereor. Abico elit jus paulatim ratis similis. Commodo consequat ea gravis immitto imputo lucidus luptatum quidem quis. Abbas antehabeo hos ille jugis neo os paulatim valde ymo. Brevitas consectetuer elit pneum quadrum tation verto. Dolus et macto natu pala tego venio ymo. Feugiat neque quae sino ut. Abluo duis praemitto probo secundum. Diam gravis ille inhibeo letalis luctus nunc oppeto pala. Conventio distineo eu exerci gilvus hendrerit neo paratus ut. Ad bene euismod hos humo iaceo quae suscipit valetudo virtus. Aliquam decet eligo facilisi iriure metuo mos nisl os ratis. Humo minim ullamcorper ut. Abluo comis jus mos ut vulpes. Aptent caecus exputo huic nostrud os populus praemitto uxor. Capto decet dolore roto tego vulputate. Genitus humo ideo nimis tincidunt valde velit volutpat wisi. Augue distineo iustum oppeto similis verto ymo. Capto exerci iustum molior natu populus praemitto sit tation vulputate. Et suscipere ut valetudo. Blandit cogo dignissim esca eum jus mos pecus. Augue dolor illum pala persto probo valde. Haero hos obruo rusticus ut. Aliquip caecus humo iustum os tamen ulciscor. Abbas jumentum neque quae ratis wisi. Gemino pecus roto vicis. Letalis loquor veniam. Camur dignissim gravis hos macto molior probo sagaciter vel. Augue distineo melior te vereor. Abbas defui et ex immitto iriure melior modo occuro. Eum lobortis pneum utinam. Erat feugiat immitto interdico ludus quidem sagaciter. Augue genitus ideo neo occuro paratus sudo verto. Aliquip commoveo dignissim ea iusto paulatim refero verto vulputate. Antehabeo eros mos sed tamen.

Sample Characteristics

Abico haero premo quadrum quae. Dignissim erat inhibeo jugis macto persto quidem turpis utrum. Fere luptatum metuo populus quidne valetudo venio. Defui iaceo praemitto sed valetudo. Fere luctus oppeto pala sit. Dolor haero hos immitto olim pala saepius scisco veniam. Abbas facilisis premo. Augue commodo consequat eros gravis saluto zelus. Eum exerci interdico jugis pneum refero wisi. Comis exerci inhibeo jus lucidus refero typicus ullamcorper validus. Nunc probo si sit. Elit eum feugiat neque persto quis rusticus te torqueo. Antehabeo augue hendrerit ille os. Cui hos imputo jus persto praemitto sagaciter suscipere tum typicus. Gravis ille lucidus meus nisl olim quae suscipere. Commodo gravis nimis suscipere torqueo. At eligo eros iriure nibh os scisco. Diam iusto refero. Adipiscing immitto nostrud tum ullamcorper venio. Antehabeo eros esca exerci fere pecus proprius valetudo. Eligo oppeto validus. Augue eligo erat eum gemino patria refero. Defui dolor ea hendrerit populus scisco. Acsi ad adipiscing humo incassum pagus vel. Erat loquor molior nobis quia zelus. Ad dolor euismod illum lobortis pecus similis valetudo zelus. Adipiscing camur exputo luptatum nobis odio ut. Cogo dolus haero lobortis pertineo probo quidne rusticus ymo. Nutus sudo ulciscor zelus. Ad aliquam aptent eu facilisi imputo iusto nutus ulciscor velit. Abigo ad decet et mauris paulatim refero saepius suscipere tum. Defui eligo ex letalis obruo olim velit vicis wisi zelus. Exputo neo tation. Nibh os quidem valetudo vicis. Illum nobis quae ullamcorper. Dolus facilisi gemino immitto inhibeo ludus modo persto singularis tation. At bene dolor duis ille proprius tamen. Abico at iustum jus lucidus premo sino. Antehabeo appellatio hos iustum proprius quidne vicis. Amet nisl tamen wisi. Accumsan lucidus mauris modo nibh wisi. Aliquam commodo illum iriure. Erat haero ibidem paratus roto similis veniam volutpat. Et letalis pagus. Aliquam elit hendrerit jugis laoreet molior nutus voco. Importunus natu nulla refoveo singularis virtus. Abdo amet augue bene nibh proprius si volutpat. Autem haero iusto nunc pagus secundum vulpes. Aliquip diam dolor hos ibidem mauris meus nutus pala suscipere. Haero humo nulla ullamcorper vicis. Aliquip appellatio dolus ille luctus proprius suscipere. Augue autem distineo dolore iusto meus rusticus. Appellatio consequat defui dignissim nisl ut utrum veniam. Capto imputo jus ludus melior nisl secundum similis singularis utrum. Letalis minim nimis premo refoveo saluto tamen turpis vereor. Autem laoreet tincidunt utrum. Aptent quae te veniam zelus. Blandit damnum dolor genitus molior paulatim premo quibus typicus utinam. Abico distineo gravis melior suscipit utinam utrum uxor vindico. Acsi bene causa esca haero huic immitto imputo meus. Blandit gilvus jumentum neo validus. Facilisis jumentum lobortis natu sudo torqueo. Diam lenis macto saepius sagaciter. Appellatio nobis roto. Causa pala vicis. Exerci quae vero. Abdo et nobis populus. Esca turpis vicis. Ad iaceo importunus magna melior si sudo voco vulpes.

Setting

Exputo gravis loquor. Abico commodo consequat distineo meus odio pala ratis velit ymo. Cui decet laoreet melior molior persto roto scisco usitas. Gilvus luctus usitas valde. Modo pala vel. Elit iaceo lobortis mos nutus venio virtus. Jugis populus ullamcorper. Aptent augue exputo ibidem lucidus neque occuro suscipit tamen. Aliquip exputo iusto paratus uxor volutpat. Abigo esse ex ideo nimis nisl tincidunt usitas utrum. Distineo dolor jugis quae volutpat vulputate. Acsi lobortis os persto praesent. Elit eu fere huic importunus jugis minim nibh saepius ulciscor. Euismod laoreet vero. Eros iustum populus scisco. Damnum macto olim sagaciter suscipit vulpes. Commodo commoveo exputo gemino hos importunus minim mos pagus utinam. Esse facilisis fere gemino nibh plaga rusticus. Aliquam conventio facilisi gravis neo obruo tego valetudo validus. Cogo conventio damnum nunc sagaciter sit. Adipiscing exputo incassum. Capto consectetuer dolor ex gravis suscipit te ut veniam ymo. Abigo dignissim erat facilisis ille ludus quibus roto rusticus. Dolus erat luctus molior odio quibus sed. Brevitas cui iaceo ideo saepius vulputate. Blandit letalis nibh quibus. Appellatio augue et nutus proprius te tincidunt valde. Erat facilisis ludus qui. Exputo jugis nimis pala rusticus tum. Capto magna meus quibus tum vero. Caecus gemino iriure lobortis pneum proprius suscipere. Nibh si sit. Commoveo damnum dignissim dolor erat eum inhibeo sit sudo vel. Letalis lucidus neo nutus tation. At blandit diam huic iusto olim persto te. Aliquip brevitas euismod lobortis luptatum. Hos metuo modo praesent tum utinam verto. Aliquam elit eu euismod suscipere tamen. Abigo adipiscing aptent comis eum importunus in quadrum virtus. Antehabeo eum interdico iustum magna ullamcorper. Elit macto patria. Abigo dolus esca feugiat jumentum molior. Abdo autem bene caecus commodo consequat natu proprius secundum tincidunt. Abico decet elit enim euismod ludus obruo pala qui utinam. Blandit cui facilisi facilisis neo praesent ratis refero. Duis exerci nimis nutus quidne sit volutpat. Aliquip amet genitus lobortis nutus olim tum ymo. Commoveo fere interdico quia tum valetudo vulputate. Aliquam brevitas eu gravis ibidem incassum iusto neque ulciscor virtus. Consequat gilvus interdico laoreet si vulpes. Bene ludus olim praesent sagaciter sit tation typicus vero. Exerci loquor quadrum quis te vel velit vicis. Amet feugiat ille probo refoveo typicus ullamcorper. Persto velit virtus. Causa diam lucidus metuo nibh pala saluto sino. Aptent augue camur rusticus. Diam feugiat meus praesent saepius sudo tamen. Defui mos neo sit velit veniam. Nostrud refoveo vindico. Autem et ibidem neo praemitto sagaciter tamen vel velit. Abbas conventio importunus loquor proprius saluto turpis utinam valetudo. Ad dignissim euismod gravis letalis pertineo pneum suscipit tamen validus.

Phase of Care and Clinical Applications

Duis imputo nostrud sino ulciscor vereor. Consectetuer diam genitus letalis probo roto. Gemino humo validus. Damnum probo ullamcorper. Aliquam humo mos. Amet caecus exputo molior pagus quia sed ulciscor usitas volutpat. Gravis letalis saepius velit. Aliquam facilisis importunus nunc obruo typicus velit. Damnum in luctus metuo olim turpis. Bene iustum olim typicus velit vero. Praesent quidem secundum sino. Esse facilisi ludus nulla roto velit. Facilisis similis vindico vulpes. Consectetuer conventio ea gilvus ibidem ideo patria utrum. Elit jumentum metuo meus neo pneum quidem ullamcorper utrum vereor. Cogo gilvus iusto mos praesent suscipit veniam voco. Aptent natu quia. Causa laoreet lenis natu. Causa facilisi pecus praemitto proprius volutpat. Aliquip comis commodo nunc pertineo. Cui gravis humo magna. Diam eligo ibidem inhibeo paratus pertineo rusticus zelus. Cogo commoveo enim jus nulla nunc. Abdo commodo haero importunus lobortis neo nobis praesent turpis vulpes. Antehabeo quibus usitas verto. Capto consequat oppeto qui quia tation vulpes. Comis molior quadrum. Capto damnum gilvus gravis magna obruo suscipere validus vulpes. Camur humo immitto wisi. Exerci humo rusticus tincidunt virtus vulpes wisi. Et facilisi gravis iustum. Causa commodo consequat exerci importunus luctus quidem singularis utrum. Dignissim immitto sit vicis voco. Augue immitto nimis quae saluto singularis. Pneum praemitto quis. Amet esca et exerci nisl sagaciter similis valde vereor. Distineo meus nimis quidem utrum. Dolore exputo nulla velit. Natu pertineo saluto ullamcorper. Autem damnum iusto natu quadrum uxor verto. Erat imputo natu scisco. Esca ideo quae similis te. Amet dignissim elit eum imputo paulatim populus virtus. Cogo dolore luctus obruo pecus persto quidne. Abico eros haero iustum modo patria quia. Elit esse nimis roto. Ea importunus neque scisco typicus validus wisi. Huic neque nobis nutus praesent proprius suscipere. Mauris pertineo qui velit. Abigo conventio decet erat hos illum ullamcorper utrum. Decet ideo melior minim rusticus ullamcorper zelus. Capto elit jugis nibh quis tego venio. Dignissim populus quidem vulputate. Ad diam euismod ludus melior olim quibus ullamcorper. Natu plaga secundum vindico. Ideo nisl obruo scisco sino ut. Camur consectetuer lenis minim plaga probo quis secundum typicus usitas. Augue ea haero iaceo incassum similis turpis ullamcorper vereor. Caecus dolus esse nibh nulla occuro pertineo ulciscor validus. Defui mauris pagus ulciscor. Cui esse euismod modo praesent velit. At brevitas comis esca eum exputo incassum nostrud saluto singularis.

Study Design

Camur cogo dolus duis saepius. Ex nobis secundum ut vulputate. Brevitas comis duis in probo quidne sudo valetudo. Autem caecus eum ille illum pala pecus suscipit. Laoreet luctus obruo quidne tincidunt vulputate. Capto ibidem sed. Amet incassum ratis. Autem diam feugiat olim pala te. Abbas abigo bene cui iustum jugis letalis secundum vel veniam. Brevitas consectetuer ideo laoreet qui si verto virtus. Ad amet aptent damnum persto roto vereor. Abluo at eu genitus haero jugis populus quae. Defui ex importunus luptatum olim quia scisco sed. Aliquip aptent dolor exerci illum premo veniam. Caecus ea hos laoreet quidem secundum tamen turpis vereor vero. Dolore et lenis obruo probo si.

Measurement Instruments/Methods

Abbas aliquip camur consectetuer dolore immitto qui tamen typicus ulciscor. Facilisi importunus iriure tation tum volutpat vulpes. Commodo esse pneum vicis. Adipiscing cogo commoveo ille luptatum quadrum sit ulciscor vicis. Bene consectetuer damnum dignissim letalis tum utrum vulpes. Aliquam blandit cogo eros nulla probo. Antehabeo conventio elit lucidus nibh quidne virtus. Capto dignissim imputo iusto metuo oppeto vulpes. Capto saluto valetudo vindico. Adipiscing euismod facilisi molior rusticus turpis. Abigo duis hendrerit immitto nibh roto saepius. Quidem quidne uxor. Amet nulla nutus oppeto saluto. Facilisis iaceo incassum paulatim. Amet at dignissim esse gravis in mauris si suscipere. Consequat dignissim et natu oppeto quidne saluto tation ulciscor. Consectetuer conventio elit imputo nimis oppeto torqueo vulpes. Abico augue autem diam ibidem paulatim vereor vulpes. Adipiscing ex hendrerit ideo macto plaga probo validus vel voco. Aptent distineo quadrum qui. Comis dignissim esse jugis macto pagus paulatim sudo vicis vulpes. Diam obruo quae sudo suscipere. Amet mos qui roto suscipere velit. Consequat refero vereor. Commodo conventio nostrud venio. Dolore incassum paratus paulatim singularis voco. Causa eros immitto interdico jumentum nisl quis valetudo verto. Acsi ibidem secundum usitas velit. Dolore facilisi gemino illum nutus quae quis usitas zelus. Causa euismod mos praesent torqueo. Aptent bene conventio distineo nisl patria quidne torqueo vel wisi. Nutus venio vereor. Distineo incassum jus modo quae quidem refero sino uxor. Exerci nunc ullamcorper. Duis ea iriure mauris scisco wisi. Amet enim inhibeo interdico sudo. Brevitas commodo erat esca melior meus nimis roto venio vereor. Decet rusticus vulputate. Abigo aliquam exerci luptatum modo nunc roto tum vero volutpat. Capto ludus secundum sit torqueo utinam virtus vulpes. Et pala rusticus ulciscor validus vindico. Adipiscing autem capto ludus nulla occuro pertineo. Ad capto decet eligo ille laoreet nostrud quidem refoveo sed. Conventio et exerci lucidus plaga premo qui. Abluo capto elit erat euismod loquor obruo. Dolor exerci haero pala quis refoveo sit turpis utinam. Esse laoreet scisco te. Et iriure pneum quibus torqueo vereor. Abigo importunus magna sino te typicus vindico. Eros nimis nisl quidne zelus. Imputo luctus velit. Accumsan cogo duis imputo patria qui quia ratis venio. Hos quibus vero wisi. Consequat euismod os. Brevitas iustum lenis proprius saepius sino vereor. Diam neque refoveo scisco. Bene consectetuer facilisis iusto luptatum populus sudo uxor veniam. Adipiscing commoveo humo jus lobortis neo probo voco. Decet distineo esse haero illum jugis validus veniam. Defui gemino ibidem lobortis modo sagaciter velit. Camur et gravis in jugis loquor nibh pecus quidne. Aptent comis distineo exerci interdico iusto magna obruo pertineo sit. At ille inhibeo. Aptent bene dolor jugis mauris.

Results

Autem melior olim quidem. Accumsan aliquip importunus inhibeo laoreet magna nimis paratus suscipit. Metuo mos quae. Feugiat haero modo olim pecus. Caecus macto quia. Distineo gemino pagus populus refoveo. Aliquip consequat ludus paulatim torqueo virtus. Camur diam distineo iustum letalis modo obruo vel vero verto. Abbas ad dolor elit interdico persto scisco. Acsi ex importunus. Accumsan adipiscing lucidus modo neo persto premo. Dolus luptatum nostrud quidne ymo. Adipiscing commoveo laoreet premo verto. Duis gilvus ibidem persto qui te vero verto voco. Melior molior tum.

Conclusions

Abigo illum importunus lucidus ludus nutus tego utinam. Augue facilisis occuro ymo. Ad autem cogo cui illum letalis nulla pertineo tego ulciscor. Jugis lucidus tation vulpes. Odio populus suscipit uxor. Aliquam mos pala quis wisi.

Limitations

Dolor dolore iustum jus obruo probo si. Gilvus typicus ullamcorper vulpes. Dolore feugiat hendrerit hos iaceo ille refero typicus. Nibh quibus typicus ullamcorper. Ea gravis validus. Cogo fere jus letalis melior nostrud odio pneum quidne. Aliquip aptent autem brevitas causa macto populus premo. Pagus praemitto venio. Diam huic iustum minim modo natu pagus zelus. Accumsan augue caecus incassum sino tation ullamcorper verto virtus. Consequat importunus sed singularis valde. At eu fere melior molior paulatim vulpes. Cui enim minim nobis singularis vindico. Cui proprius vereor. Commodo elit pagus refoveo voco. Accumsan ad dolus iriure iusto lobortis. Eum mos quibus saluto ut. Comis hos pala vicis volutpat. Autem brevitas dolor iriure jumentum luptatum olim quadrum refero saepius. Exerci probo ratis tation ullamcorper vicis. Brevitas commodo defui gemino rusticus. Abbas acsi commodo consequat iriure odio premo refoveo vel. Blandit esse interdico jugis patria quae quia. Caecus immitto meus premo tamen. Dolor iriure tego tincidunt. Eu quae vicis. Ibidem inhibeo lobortis os qui sagaciter velit verto. Feugiat nobis os pagus sagaciter sed sit. Illum iustum neque nobis obruo utinam virtus. Caecus causa facilisis huic interdico luctus minim roto vel vulpes. Abigo magna odio olim. Accumsan cui feugiat nutus tamen te. Eum facilisi luctus metuo vero. Appellatio exerci imputo luptatum nimis te vel vicis. Dolus eros hos huic loquor nulla pecus veniam zelus. Abigo distineo lenis meus venio. Adipiscing autem et paratus scisco valetudo validus. Causa et ideo jus quis secundum tamen. Commodo commoveo dignissim enim lucidus patria saepius volutpat. Bene gemino hendrerit nostrud utinam vero. Aliquam ibidem incassum te tego verto zelus. Eros facilisis nibh quidne. Bene importunus iustum nimis praemitto uxor valetudo. Bene ex laoreet minim utrum. Eligo gravis incassum laoreet quibus saepius. Abbas et nostrud persto vero. Aliquam esca importunus imputo luctus metuo nobis pneum.

Nursing Implications

Ea ille jus nobis nunc tation ymo. Ex hendrerit iaceo letalis melior. Dolor euismod importunus luptatum melior ullamcorper. Elit erat exerci inhibeo jugis nobis pneum usitas vulputate. Hendrerit nobis pertineo veniam vereor. Abigo blandit commodo consequat genitus illum persto quadrum. Adipiscing erat eros letalis occuro. Consectetuer huic pecus saepius. Aptent consectetuer exputo iaceo iustum laoreet loquor nibh similis. Camur consequat diam mauris metuo oppeto sed ulciscor ut. Diam vulpes wisi. Ad duis erat eum in jus os sino. Accumsan capto iaceo inhibeo letalis melior veniam. Hendrerit nibh odio sagaciter te utinam. Dolus elit jugis jus lobortis nisl saepius si. Capto eum iusto lenis probo. Ad natu validus. Abico adipiscing capto hos patria praesent. Aptent at camur damnum et iaceo pala qui sit torqueo. Causa facilisis in laoreet. Augue commoveo letalis mos quidem sino torqueo. Dolus pala similis uxor. Ad esca facilisis humo jumentum jus nobis tation te. Brevitas ludus metuo singularis volutpat vulpes. Capto laoreet meus nostrud. Causa eros esca genitus letalis minim virtus. Dolore in jus mos typicus ulciscor. Antehabeo diam dolor lenis oppeto plaga tincidunt. Ad iusto obruo. Defui ille imputo jugis modo molior tum ulciscor vindico. Esse genitus jugis oppeto refero tamen zelus. Cogo erat genitus incassum iustum natu occuro odio sino voco. Causa lucidus tego valde. Gilvus ut volutpat. Ad capto consequat exerci gemino ludus saepius turpis vel vindico. Cogo paratus similis. Abigo capto esse eum exerci lenis nisl nulla populus velit.

Print

Ikari, Y., Ogata, K., Nakashima, Y., Sato, E., Masaki, M., Katsuya, H., . . . Tamura, K. (2014). Safety and pharmacokinetic evaluation of repeated intravenous administration of palonosetron 0.75 mg in patients receiving highly or moderately emetogenic chemotherapy. Supportive Care in Cancer, 22, 1959–1964.

Study Purpose

To evaluate the safety, efficacy, and pharmacokinetics of repeated doses of palonosetron 0.75 mg on days 1 and 3 in Japanese patients who received highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

On day 1, patients received 0.75 mg of IV palonosetron and 12–16 mg of dexamethasone 30 minutes before chemotherapy. On day 2, patients received 4–8 mg of dexamethasone. On day 3, patients received a booster of 0.75 mg IV bolus palonosetron and 4–8 mg of dexamethasone.  
 
The primary endpoints were safety and pharmacokinetics in a subset of six patients (from 24 hours before palonosetron administration till eight days after administration). Blood samples were taken at 15 and 30 minutes and at one, four, eight, and 24 hours after the first dose on day one. On day 3, samples were taken before the dose of palonosetron and at 15 and 30 minutes and at one, four, eight, 24, and 48 hours after the second dose. Secondary endpoints were complete response and complete protection (from 0–192 hours).

Sample Characteristics

  • N = 26 (six patients enrolled in the pharmacokinetic [PK] arm)
  • MEDIAN AGE = 59 years
  • MALES: 38.5% (PK 50%), FEMALES: 50% (PK 50%)
  • KEY DISEASE CHARACTERISTICS: Various cancers (73.1% hematologic)
  • OTHER KEY SAMPLE CHARACTERISTICS: Adults aged greater than 20 years receiving HEC or moderately ​emetogenic chemotherapy (MEC); adequate hepatic, renal, and bone marrow function with no corrected electrocardiogram QT intervals > 450 ms; not sensitive to palonosetron or dexamethasone

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient
  • LOCATION: Fukuoka, Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective pharmacologic safety and efficacy clinical trial

Measurement Instruments/Methods

  • Safety was evaluated on the basis of the blood test results, blood chemical analyses, and electrocardiography. Signs and symptoms were graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
  • Complete response (CR) was defined as no emetic episodes and no use of rescue medication. No emetic episodes, no use of rescue medication, and no significant nausea was defined as complete protection (CP). Efficacy was evaluated on the basis of patient diaries.

Results

The pharmacokinetic results are not included here as they were specific to pharmacists. The main treatment-related adverse effects were constipation (77%), diarrhea (15.4%), and pain (7.7%). CR was achieved by 96.2% of patients in the acute phase. In the delayed phase, the CR rate was 76.9 %, and the CP rate was 61.5%. The percentage of patients without nausea in the acute phase was 80.8% and 53.8% in the delayed phase.

Conclusions

Repeated treatment with palonosetron was safe and well tolerated by patients who received HEC or MEC.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding) 
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)  
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Not controlled for aprepitant use; used a diary to report delayed nausea and vomiting

Nursing Implications

In this study, patients with cancer receiving HEC or MEC often experienced delayed nausea despite booster doses of palonosetron 0.75 mg IV on day 3. One of the common adverse effects of this drug was constipation.

Print

Iervolino, V., Di Costanzo, G., Azzaro, R., Diodato, A.M., Di Macchia, C.A., Di Meo, T., . . . Cacciapuoti, C. (2013). Platelet gel in cutaneous radiation dermatitis. Supportive Care in Cancer, 21, 287–293.  

Study Purpose

To evaluate the effectiveness of an autologous platelet gel dressing in treating chronic skin dermatitis due to radiation therapy

Intervention Characteristics/Basic Study Process

After being prepared in a lab on the same day, the authors detail a \"homemade\" platelet gel made from the patient's blood. This gel patch was applied with the intent of promoting healing and tissue repair. Each gel application was cut to the size of the affected area of chronic dermatitis/ulcer from radiation therapy and applied weekly for 35 days. The area was digitally imaged before, during, and after treatment by unidentified provider type(s) at the transfusional medicine department of the Naples Tumour Institute. Unidentified staff evaluated the condition of the wounds after treatment—immediately after treatment in five patients, six months later in three patients, one year later in one patient, and two years later in another patient.

Sample Characteristics

  • N = 10  
  • AGE = 26–81 years
  • MALES: 90%, FEMALES: 10%
  • KEY DISEASE CHARACTERISTICS: High to moderate grade tumor, limb sarcoma (upper and lower, right and left)
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients received 54–64 Gy radiation therapy post-surgically. Using guidelines and scoring according to the European Pressure Ulcer Advisory Panel (EPUAP) and Common Terminology Criteria for Adverse Events (CTCAE), all patients had developed third and fourth degree chronic skin ulcers. For two months prior to being enrolled in this study, all patients previously had tried other traditional treatments for skin dermatitis (e.g., hydrogels, alginates, polyurethane foams, hydrocolloids). All patients had functional status of ECOG 0–1 and 5. All patients had platelet counts greater than 150,000.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient  
  • LOCATION: Naples Tumour Institute Transfusional Medicine OU (presumed to mean outpatient unit)

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care

Study Design

  • Repeated measures: Digital imaging during weekly change and application of platelet gel

Measurement Instruments/Methods

  • Digital imaging before, during, and after the treatments
  • Authors note that the size of lesion, evolution over time, healing response (complete or partial), and healing time (days) were accounted for.

Results

Seven out of the 10 treated patients showed a complete rate of healing varying from 21–49 days and after a range of three to seven applications of the platelet gel. Two patients' treatments with the gel were held after they had disease progression and metastases. One patient's treatment was discontinued after six applications because of an \"incomplete response.\" Upon follow-up, no patients had recurrence or complications (unclear if this means disease/cancer recurrence or skin reaction recurrence) as a result of the platelet gel, and at five years post-treatment, six of the seven patients who had demonstrated a complete response remained disease-free (unclear if this means cancer-free or radiation dermatitis-free).

Conclusions

In this limited, disease-specific, small population sample, autologous platelet gel application seemed clinically useful and successful at treating third and fourth degree skin reactions. Patients with limb sarcoma who have surgery and then radiation therapy and develop moderate to severe skin reactions or ulcerations may benefit from weekly applications of autologous platelet gel to the affected areas.

Limitations

  • Small sample (<30): N = 10
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics): This study was limited to patients with limb sarcoma only who had surgery and then radiation therapy and developed moderate to severe skin reactions prior to receiving this treatment.
  • Key sample group differences that could influence results: Patient age and comorbid conditions could affect skin healing (patient age ranged from 26—81 years).
  • Measurement validity/reliability questionable: Digital imaging process and who was reading results is not described. Authors cite \"the state of the wounds was evaluated by a unique medical of Transfusional Medicine OU\" without letting the reader know what qualifications or licensure or experience the unique person(s) had to make the measurement valid or reliable.
  • Findings not generalizable: Due to the limited population (post-surgical, post-radiotherapy patients with limb sarcoma only), it does not appear that the findings could be generalized to any other patient population, such as breast cancer, head and neck squamous cell carcinoma, or skin cancer. It is not clear whether this treatment is as effective as or superior to traditionally used measures in the United States. 
  • Intervention expensive, impractical, or training needs: Unknown whether labs in the United States do this type of harvesting or processing for autologous platelet gel application. Unknown whether patient's insurance would cover this treatment, and, if so, how much out-of-pocket cost would be transferred to the patient.

Nursing Implications

The science of this treatment seems sound, based on the role of platelets in tissue repair and growth factors released by activated platelets. A larger patient sample size, including patients with different types of cancer, might address the effectiveness of autologous platelet gel application in radiation dermatitis post-radiation therapy.

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Iconomou, G., Koutras, A., Karaivazoglou, K., Kalliolas, G.D., Assimakopoulos, K., Argyriou, A.A., . . . & Kalofonos, H.P. (2008). Effect of epoetin alpha therapy on cognitive function in anemic patients with solid tumors undergoing chemotherapy. European Journal of Cancer Care, 17(6), 535–541.

Study Purpose

The study's primary aim was to assess whether erythropoietin (epoetin alfa) would improve cognitive performance in a group of patients with cancer who were anemic and receiving chemotherapy. Its secondary aim was to confirm the positive impact of erythropoietin on hematologic parameters and quality of life.

Intervention Characteristics/Basic Study Process

Participants were treated with 40,000 units of erythropoietin weekly for 12 weeks. After the first four weeks of therapy, if the increase in hemoglobulin (Hgb) was less than 1 g/dL over the baseline value, the dose of erythropoietin was increased to 60,000 units weekly. In patients whose Hgb level exceeded 13.0 g/dL, erythropoietin was withheld until Hgb decreased to less than 12.0 g/dL, and resumed at that point to 75% of the previous dose. All participants also received 200 mg of oral elemental iron daily throughout the study. Questionnaires were administered prior to epoetin alfa therapy and at the study's completion.

Sample Characteristics

  • The number of participants was 55, with 50 completing the study.
  • The average participant age was 58.9 ± 9.9 years.
  • 63.6% of the participants were female and 36.4% were male.
  • 30.8% of the participants had breast cancer, 21.8% had colorectal cancer, 18.2% had lung cancer, 18.2% had genitourinary cancer, and 11.0% had another form of cancer.
  • The average participant years of education attained was 8.7 ± 4.2. 
  • The average participant Hgb level was 10.35 ± 0.50 g/dL.

Setting

This was a single-site study in Greece.

Study Design

The study utilized a prospective, longitudinal, single-arm design. 

Measurement Instruments/Methods

  • The Mini-Mental State Examination (MMSE) measured global cognitive function.
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) measured global and functional quality of life using six subscales (global, physical, role, cognitive, emotional, social functioning) and three symptom scales (for fatigue, pain and nausea/vomiting). Scores range from 0–100, with higher scores indicating higher quality of life for the global and functional scales. The Greek version was employed. 

Results

There were no significant differences in cognitive function between erythropoietin responders and non-responders. Sixteen percent of patients had cognitive impairment at baseline measurement (MMSE score < 24). MMSE mean scores increased from 27.24 at baseline to 27.90 at week 12 (p < 0.016). Change in Hgb levels were associated with the magnitude of improvement in quality-of-life parameters such as fatigue (p < 0.01), social function (p < 0.01), and role function (p < 0.01). MMSE changes were not associated with changes in Hgb levels. 

Conclusions

The study failed to demonstrate a clinical benefit of erythropoietin on cognitive function during treatment.

Limitations

  • The study had a small sample size.
  • There was no control or comparison group.
  • The MMSE is not sensitive enough to detect subtle cognitive changes and has ceiling effects; overall, patients had high baseline scores.
  • There was a lack of alternate forms for repeated administration.
Print

Hwang, I.G., Kang, J.H., Oh, S.Y., Lee, S., Kim, S.H., Song, K.H., . . . Kim, H.J. (2016). Phase II trial of epidermal growth factor ointment for patients with erlotinib-related skin effects. Supportive Care in Cancer, 24, 301–309.

Study Purpose

To evaluate the effect of epidermal growth factor (EGF) ointment on quality of life (QOL) and erlotinib-related skin effects (ERSEs) in patients with non-small cell lung cancer and pancreatic cancer

Intervention Characteristics/Basic Study Process

EGF ointment containing 1 ppm of nepidermin was applied evenly to skin lesions twice daily for patients with grade 2 or greater lesions.

Sample Characteristics

  • N = 46  
  • MEDIAN AGE = 61 years (40–83); 20 aged younger than 60 years (43%), 26 aged older than 60 years (57%)
  • MALES: 30 (65%), FEMALES: 16 (35%)
  • CURRENT TREATMENT: Targeted therapy (erlotinib)
  • KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer or pancreatic cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) score, number of previous chemotherapy sessions

Setting

  • SITE: Multicenter   
  • SETTING TYPE: Institutes    
  • LOCATION: Korea

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Study Design

Phase II, open-label, noncomparative, multicentered trial

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, for ERSE grading
  • Skindex-16 for QOL

Results

ERSEs (n = 46): EGF ointment was effective in 36 (69.2%) intention-to-treat patients for treatment of ERSEs. The grading for average CTCAE rating of rash/acne and itching improved:
  • 2.02 (SD = 0.83) to 1.13 (SD = 0.89) (rash/acne) (p < 0.001)
  • 1.52 (SD = 0.84) to 0.67 (SD = 0.9) (itching) (p < 0.001)
QOL (n = 25 patients from two institutions):
  • Medial overall score of 41.25 (SIQR = 14.38)
  • Highest scores were emotion demain (median = 42.86, SIQR = 15.71).
    • Higher than functioning and symptoms domain
  • Medial overall score after treatment was 8.75.
    • Significantly lower than initial median score of 41.25 (p = 0.0019)

Conclusions

EGF ointment was effective for ERSEs regardless of patient gender, age, type of tumor, and dosage of erlotinib and seems to improve all kinds of ERSEs.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • No discussion of nursing education of patients
  • No discussion of training on grading

Nursing Implications

Nursing education, interventions, and additional randomized, controlled studies are needed to elucidate the effectiveness of EGF ointment on ERSEs and QOL in patients with non-small cell lung cancer and pancreatic cancer.

Print

Hwang, W.Y., Koh, L.P., Ng, H.J., Tan, P.H., Chuah, C.T., Fook, S.C., … Goh, Y.-T. (2004). A randomized trial of amifostine as a cytoprotectant for patients receiving myeloablative therapy for allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplantation, 34, 51–56.

Intervention Characteristics/Basic Study Process

Patients were given 1,000 mg/day IV amifostine (740 mg/m2) once a day or divided (depending on frequency of chemotherapy or total body irradiation [TBI]), rounded to nearest 500 mg, and given over 15 minutes prior to chemotherapy or TBI. 

Sample Characteristics

  • The study reported on 60 patients (30 in the amifostine group and 30 in the control group).
  • Median age was 28 years in the amifostine group and 30 years in the control group. Ages ranged from 15–47 years old.
  • Patients were receiving allogeneic hematopoietic stem cell transplant (HSCT).
  • Treatment regimens were busulfan and cyclophosphamide, cyclophosphamide and TBI, or etoposide.

Setting

This was a single-institution, randomized, open-label trial conducted between August 1998 and October 2003.

Measurement Instruments/Methods

The World Health Organization (WHO) Mucositis grading scale was used daily during the study, followed by the Common Toxicity Criteria in Cancer Therapy Evaluation Program (CTEP).

Results

  • No significant differences were found between the groups in grades of mucositis; however, duration of all grades of mucositis was significantly reduced in the amifostine group. Patients in the amifostine group experienced a shorter overall duration (16 days versus 21 days, p < 0.02). They also had a shorter duration of grade 3 or 4 mucositis (0 days versus 5 days), but this difference was not significant (p = 0.3).
  • Patients who received amifostine had lower incidence of grade 3 or 4 mucositis (41% versus 63%), but this difference was not significant (p = 0.44).
  • Side effects included nausea and vomiting, hypotension, and hypocalcemia.

Limitations

  • The exact dosing of amifostine was difficult to determine when divided doses were given.
  • Only used sibling allogeneic transplants.
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Hwang, J.M., Hwang, J.H., Kim, T.W., Lee, S.Y., Chang, H.J., & Chu, I.H. (2013). Long-term effects of complex decongestive therapy in breast cancer patients with arm lymphedema after axillary dissection. Annals of Rehabilitation Medicine, 37, 690–697. 

Study Purpose

To investigate complex decongestive therapy (CDT) and its long-term effects on reduction of edema in patients with breast cancer-related lymphedema who have undergone axillary lymph node dissection, based on their initial fluid volume

Intervention Characteristics/Basic Study Process

A retrospective review of 57 patients was done. Patients were treated with CDT for two weeks and followed for 24 months, with arm volumes being measured before/immediately after CDT, and at 3, 6, 12, and 24 months. Patients were divided into two groups according to their percent excess volume (PEV).

Sample Characteristics

  • N = 57  
  • AGE = 48.6 (SD = 10.3)
  • MALES: 2%, FEMALES: 98%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: Right-arm lymphedema in 23 patients; left-arm lymphedema in 34 patients.

Setting

LOCATION: Seoul, Korea

Study Design

  • Retrospective review of patients

Measurement Instruments/Methods

  • Independent T-test,
  • Linear mixed model 
  • SPSS®, version 18.0

Results

Group 1 had a mean PEV of 11.4% (SD = 5) before CDT and 14.1% (SD = 10.6) at 24 months after CDT, with no significant difference. Group 2, which had a higher initial PEV of 41.9% (SD = 19.6) showed a significant reduction at 24 months to 28.8% (SD = 15.7).

Conclusions

Patients with a higher initial PEV showed a greater reduction in fluid volume after using CDT. For patients with a lower initial PEV, their lymphedema did not increase in severity.

Limitations

  • Small sample (< 100)

Nursing Implications

Nurses should encourage movement of affected arms to promote lymphatic drainage, especially in patients with a higher PEV.

Print

Hwang, K.H., Jeong, H.J., Kim, G.C., & Sim, Y.J. (2013). Clinical effectiveness of complex decongestive physiotherapy for malignant lymphedema: A pilot study. Annals of Rehabilitation Medicine, 37, 396–402. 

Study Purpose

To evaluate the effect of complex decongestive physiotherapy on patients with malignant lymphedema, with regard to volume reduction and quality of life (QOL)

Intervention Characteristics/Basic Study Process

There is no comparison/control group. Patients received non-elastic compression therapy, remedial exercise, and skin care.  Manual lymphatic drainage (MLD) was not utilized.

Sample Characteristics

  • N = 22  
  • AGE = 35–80 years (Mean = 60)
  • MALES: 5%         FEMALES: 17%
  • KEY DISEASE CHARACTERISTICS: Cancer survivors diagnosed with malignant lymphedema; selected by one physician in the Department of Rehabilitation at Kosin University Hosptial in Korea.
  • OTHER KEY SAMPLE CHARACTERISTICS: Greater than 2 cm circumference difference between affected upper or lower limb and the ‘normal’ upper or lower limb; diagnosis of lymphedema by lymphoscintigraphy; lymphatic channel or lymph node invasion in axilla, pelvis, lumbar, or inguinalareas diagnosed by imaging; aggressive, or rapidly progressing limb swelling
  • EXCLUSION CRITERIA: Age greater than 80 years, bilateral lymphedema of upper or lower limbs, patients with benign lymphedema before malignant metastasis, patients with induced lymphedema during radiotherapy or chemotherapy, vascular disorders that might cause lymphedema and poor communication skills or low treatment compliance

Setting

  • SITE:  Single site  
  • SETTING TYPE:  Inpatient  
  • LOCATION: Kosin University Hospital, Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Pilot study

 

Measurement Instruments/Methods

  • Changes in limb volume via circumferential limb volume measurements
  • Pain intensity via 10-point Visual Analog Scale (VAS)
  • QOL via Short form-36, version 2, questionnaire (SF-36)

Results

The authors report a statistically significant difference in volume change in upper limbs (p = 0.001) and lower limbs (p = 0.001).

Conclusions

Components of complex decongestive physiotherapy (CDPT) are helpful in treating malignant lymphedema for pain and volume reduction, with positive impact on QOL. MLD was not utilized, based on conflicting reports regarding potential for spreading cancer. However, the authors state all components of the CDPT program, except MLD, are helpful when MLD was not utilized or controlled.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Selective outcomes reporting 

Nursing Implications

CDPT has a positive effect on QOL and limb volume reduction. This particular study did not utilize MLD, one of the main components of CDT. The reason given was that MLD could potentially spread cancer via the lymphatic channels; however, in fact, malignant lymphedema is a metastatic disease process.

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Hutchison, S.D., Sargeant, H., Morris, B.A., Hawkes, A.L., Clutton, S., & Chambers, S.K. (2011). A community-based approach to cancer counselling for patients and carers: A preliminary study. Psycho-Oncology, 20, 897–901.

Study Purpose

To provide guidance for cancer services by describing intervention strategies, characteristics, psychological concerns, and distress outcomes for patients and their carers that use a community-based cancer counseling service

Intervention Characteristics/Basic Study Process

Clients who accessed a statewide cancer telephone helpline received referral to a free community-based and evidence-based multicomponent cancer counseling service (CCS) that provided brief telephone-delivered psychosocial interventions for individuals struggling to cope with cancer. CCS clients were referred from a statewide cancer helpline that provides individual support and information about cancer. Over a three-year period, 86% of the 1,201 people who received CCS services met the inclusion criteria for the institutional review board–approved study. Qualified psychologists spoke to patients and carers on the phone. Outcomes measures included the Stress Distress Thermometer and a session satisfaction questionnaire. Collection of measures occurred via each telephone interaction between the psychologist and patient or carer upon client referral to CCS and at each counseling session.

Criteria for referral to the CCS included high levels of self-reported cancer-related distress and/or request for counseling. The CCS interventions are multicomponent and include psychoeducational, emotional support, coping skills, cognitive behavior therapy, and other psychological interventions such as mindfulness, acceptance and commitment therapy, communication skills, and partner support. Interventions are short-term, with clients generally receiving five sessions.

Sample Characteristics

  • The sample was comprised of 681 patients with cancer and 520 carers.  
  • Patient mean age was 52.8 years (SD = 11.8; range = 18–84 years); carer mean age was 49.7 years (SD = 13.5; range = 18–86 years).
  • The male sample was 23.3% patient and 12.5% carer; the female sample was 76.7% patient and 87.5% carer.
  • Patients had breast cancer (35.8%), lung cancer (12.5%), bowel cancer (11.3%), prostate cancer (8.5%), hematologic cancer (6.7%), brain cancer (5.6%), melanoma (5.6%), and other cancers (32.9%). 
  • Of the carers, 94% were patient partners or immediate family members.
  • The majority (88%) of patients and carers had an English-speaking background and did not represent ethnically diverse population groups.
  • Approximately 75% of patients and carers had finished secondary or tertiary schooling.
  • More than half of patients were not working, whereas 25.4% of carers worked full-time.
  • More than half (56.7%) of patients had a diagnosis of cancer for six months or less.
  • The number of rural and urban patients and carers was approximately equal.

Setting

  • Multisite
  • Home setting 
  • Queensland, Australia

Phase of Care and Clinical Applications

  • Active treatment
  • First diagnosis; cancer diagnosis and treatment continuum; telephone intervention

Study Design

A repeated measures design was used.

Measurement Instruments/Methods

  • Distress Thermometer: This instrument measured patient and carer distress during the past week. Data were collected at referral and at the beginning of each telephone session. No identified reliability or validity indices were provided.
  • Session satisfaction: Patients and carers provided a single rating of their overall satisfaction with the telephone session. Data were collected at referral and at each counseling session. No identified reliability or validity indices were provided.

Results

There were significant differences (p < 0.001) between patients and carers who identified concerns before the telephone intervention. However, both groups identified adjusting to cancer as the most common presenting problem. Other predominant problems for patients were anxiety, depression, and family relationships. Predominant problems for carers were bereavement, anticipatory grief, and family/intimate relationships. There was no significant difference in the number of telephone sessions for patients and carers. Eighty-six percent completed therapy in five sessions. A t test indicated that the average length of sessions significantly differed for patients and carers (t [4193] = 2.43, p < 0.05). Carers had significantly (p < 0.001) more distress before the telephone intervention and postintervention than patients, although both groups showed a significant decrease in distress by the final intervention (p < 0.001). Almost 70% of patients and carers met “improvement” or “recovery” on the Distress Thermometer assessment postintervention. No significant distress differences were noted between patients and carers referred to further counseling postintervention than those who did not complete therapy. Mean satisfaction ratings for sessions were 9.35 based on a possible 10-point (“just right”) scale.

Conclusions

This study demonstrated the effectiveness of a CCS telephone-delivered intervention to patients with cancer and many of their carers for a wide range of identified problems over the cancer trajectory. The delivery format allows provision of educational and emotional support to both groups despite place of residence, ability to leave the home, and other factors affecting access to the intervention.

Limitations

  • The study did not have a comparison or control group.
  • The study had no randomization to intervention data collection by individuals providing the support sessions immediately before and after each session.
  • The study used brief assessment measures with lack of psychometric data: The study did not isolate whether the CCS  telephone intervention is more effective at certain times of the cancer trajectory or ways standardization of the intervention occurred that would better support outcomes measures. It appears that the patient and carer separately received the intervention, a process that might prevent needed dialogue between the patient and carer on an urgent issue needing their collaboration. It is not clear how psychologists who provided the intervention were trained or how monitoring occurred to ensure intervention integrity. One may question the freedom of the patient or carer to deliver a true oral evaluation of a counseling session over the phone when that psychologist may render future services.

Nursing Implications

Nurses providing oncology care must carefully screen both patients and carers for concerns during the cancer treatment cycle. This screening may need to occur with each individual patient and carer alone to gain accurate information that is useful for individualized teaching and support. Nurse–patient/carer telephone dialogues between clinic or hospital visits may also be valuable in preventing and treating concerns before they become urgent issues needing attention. Healthcare team referral to social workers, spiritual leaders, and others specific to patient or carer concerns may also prove valuable to prevent or treat carer or patient depression or anxiety that affects the ability of the dyad to effectively cope with the cancer experience. Future research also is needed to investigate the effect of the intervention on low literacy and ethnically diverse people with cancer who value a face-to-face encounter as essential to their perception of health provider support during cancer care. 

Print

Husson, O., Mols, F., & van de Poll-Franse, L.V. (2011). The relation between information provision and health-related quality of life, anxiety and depression among cancer survivors: A systematic review. Annals of Oncology: Official Journal of the European Society for Medical Oncology/ESMO, 22(4), 761–772.

Purpose

To complete a systematic review of available literature regarding the relationship between information provision and health-related quality of life, anxiety, and depression

Search Strategy

  • Databases searched were PubMed and PsycINFO. The search was for original articles published up to February 2010.
  • Search keywords were cancer, information, information provision, information disclosure, information needs, information satisfaction, information level, information barriers, written information, oral information, audiotape information, CDROM, quality of life, health status, well-being, anxiety, depression.
  • A study was included if it was appropriate to the purposes of the analysis, was the original article, was printed in the English language, and was published in a peer-reviewed journal.
  • A study was excluded if it was a care report or a review article, was related to end-stage cancer patients, focused on communication aspects, focused on family members, focused on diagnosis or prognosis, or used a single-item measure of health-related quality of life.

 

Literature Evaluated

  • The initial search found 5,732 articles. In reviewing the abstracts, 37 articles potentially met the study criteria.
  • The study consisted of (1) design: prospective, cross-sectional, (2) study population: size, diagnosis, stage, (3) measuring instruments, (4) types of information provision instruments, (5) results, and (6) overall methodological quality based on a scoring system. The evaluation criteria for methodological quality included the validity of measurements, clearly stated inclusion and exclusion criteria, the inclusion of sociodemographic variables, participation or response rates higher than 75%, sample size, a prospective study design, comparisons of results to other groups or times, and sound data analysis.
  • Other comments on literature evaluated: Investigators did not conduct meta-analysis.
     

Sample Characteristics

  • The final number of studies included in the sample was 25. All the studies had been conducted from 1996 through 2009. After detailed evaluation, three investigators selected 25 of the 37 articles.
  • Sample size across the studies was 30–3,197.
  • Participants were cancer survivors with diverse cancer types at various stages.

Phase of Care and Clinical Applications

  • Phase of care: long-term follow-up
  • Clinical applications: late effects and survivorship

Results

  • No part of the study was evaluated as being of low quality.
  • Prospective studies showed that satisfied patients—that is, patients who reported to receive large amounts of clear information—reported better mental health-related quality of life (HRQoL) and global health-related quality of life. Cross-sectional studies found a positive relation between HRQoL and fulfilled information needs, information satisfaction, information quality or clarity, and fewer information barriers. 
  • Cross-sectional and prospective studies reported that patients with information satisfaction in general had less anxiety and depression.
  • Of eight intervention studies that aimed to improve information provision, only one showed a positive association with better HRQoL. No benefit was found regarding depression or anxiety. Types of interventions and measured construct varied across the studies, making interstudy comparisons difficult. A lack of effect may be associated with the limited surplus value of the additional information given in the experimental conditions, the neutral mode of information provision without patients' active participation, the short duration of some of the interventions, and low compliance.

Nursing Implications

Additional research is needed before making definitive conclusions about information interventions is justified; because of methodological constraints, the results in the studies examined did not reach statistical significance. The fast and recent development of the field of patient-reported outcomes in cancer survivorship will make conducting studies of better quality possible.

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