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Becker, G., Galandi, D., & Blum, H.E. (2007). Peripherally acting opioid antagonists in the treatment of opiate-related constipation: A systematic review. Journal of Pain and Symptom Management, 34, 547-565.

Purpose

To evaluate evidence on the effectiveness of the peripherally acting mu-receptor antagonists alvimopan and methylnaltrexone in the management of opioid-induced constipation.

Search Strategy

Databases searched were Ovid MEDLINE, Biological Abstracts, BIOSIS Previews, CINAHL, Evidence-Based Medicine Reviews (EBMR) (Cochrane Database of Systematic Reviews, ACP [American College of Physicians] Journal Club, Database of Abstracts of Reviews of Effectiveness [DARE], and the Cochrane Central Register of Controlled Trials [1966-May 2005]), PubMed (1996-May 2005), CancerLit (1963-June 2005), and Embase (1980-May 2002). A hand search also was conducted on bibliographies of books about palliative care.  From that hand search, reference citations concerning constipation were identified to find additional clinical trials to include in the review.

Search keywords were constipation, intestinal obstruction, opioid bowel dysfunction, opioid related constipation, opioid-related disorders, peripherally acting opioid antagonist, opioid antagonist, opioid mu receptors, narcotic antagonists/naltrexone, methylnaltrexone, and alvimopan.

Studies were included in the review if

  • The trial population comprised adults with opioid-related constipation who (a) had chronic pain and were being treated with an opioid regimen, (b) were on methadone maintenance programs, or (c) were healthy volunteers used as models to reproduce the condition of real patients.
  • The sample size was at least 10 participants.
  • The intervention treatment was with methylnaltrexone or alvimopan.
  • The outcome measures of prevention or reduction of constipation and the incidence of adverse events were addressed.

Studies were excluded if they had a small sample size (fewer than 10 participants) or used the Rome Diagnostic Criteria to define constipation.

Literature Evaluated

Ten studies were appropriate for this review. However, four of the 10 had two or three parts performed in different populations or using different dosing regimens. The differing parts were treated as different studies and assessed individually, yielding 15 studies (10 randomized controlled trials and five phase II studies addressing dose and toxicity).

Sample Characteristics

  • Study groups ranged in size from 11 to 168 participants, for a total of 605 participants in all 15 studies.
  • Seven studies included healthy volunteers, two included members of methadone maintenance programs, and three included both members of methadone maintenance programs and patients with chronic pain.
  • One study looked at patients receiving opioids for acute pain and two included hospice patients.

Results

This systematic review looked mainly at the efficacy of using the peripherally acting opioid antagonists methylnaltrexone (nine studies) and alvimopan (six studies) in managing opioid-induced constipation. Internal validity of the studies was high, indicating methylnaltrexone and alvimopan may be effective in relieving opioid-induced constipation. However, most study participants were healthy volunteers or members of methadone programs.

Limitations

  • The studies in this review addressed the efficacy of methylnaltrexone and alvimopan. However, most study participants were healthy volunteers or members of methadone programs. The question arises as to whether the effectiveness of those drugs would hold true in other populations.
  • Additional research is needed to assess the effectiveness of methylnaltrexone and alvimopan in patients with cancer. Not all of the studies addressed the effects of those peripherally acting antagonists on pain control and withdrawal. Of the 15 studies, five reported no effect on pain and seven reported no withdrawal effects. The effects of those drugs on pain and withdrawal require additional study.
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Beck, M., Wanchai, A., Stewart, B.R., Cormier, J.N., & Armer, J.M. (2012). Palliative care for cancer-related lymphedema: A systematic review. Journal of Palliative Medicine, 15(7), 821–827.

Purpose

To a conduct a systematic review of the published literature related to the effectiveness of cancer-related lymphedema management in palliative care

Search Strategy

Databases searched were PubMed, MEDLINE, CINAHL, Cochrane Library databases, PapersFirst, Proceedings First, Worldcat, PEDro, National Guidelines Clearing House, ACP Journal Club, and Dare.

Search keywords were lymphedema (lymphoedema, lymphodema, elephantiasis, swelling, edema, and oedema) and palliative care (advanced disease and metastatic cancer).

Studies were included in the reivew if they related to lymphedema management in the setting of palliative care, including randomized controlled trials, cohort studies, case-control studies, meta-analyses, and systematic reviews.

Studies were excluded if they

  • Had no available English translation
  • Did not evaluate an intervention
  • Did not address lymphedema in the palliative care period
  • Were abstracts only, letters to the editor, cross-sectional studies, qualitative studies, or general lymphedema overviews.

Literature Evaluated

  • Using the search terms, 31 references were retrieved.
  • The research was evaluated using the PEP categories of levels of evidence.

Sample Characteristics

  • Eleven studies were included.
  • Samples sizes ranged from 1–90 across studies.
  • Samples included patients with various types of advanced or metastatic cancer and lymphedema.

Phase of Care and Clinical Applications

Patients were undergoing end-of-life and palliative care.

Results

The study identified four categories of lymphedema in the palliative care settings.

  • Five case studies addressed closed-controlled subcutaneous drainage.
  • One retrospective study dealt with manual lymphatic drainage (MLD).
  • Two case studies looked at compression therapy.
  • Three case studies addressed complete decongestive therapy (CDT).

Only a few studies (4 out of 11) included objective measures of outcomes. All studies were in the category of \"Effectiveness Not Established\" assessed by the Oncology Nursing Society Putting Evidence Into Practice classification.

Conclusions

A lack of rigorously designed clinical research studies have been conducted pertaining to the treatment of lymphedema in patients with advanced or metastatic cancer.

Limitations

  • Articles published prior to January 2004 were not included in this systematic review. The authors did not provide an explanation for this.
  • Articles with no available English translation were excluded. This exclusion criterion indicates that articles from non-English countries (e.g., Germany, China, and India) were not reviewed; however, the authors did not state the possible number of these non-English articles.

Nursing Implications

This systematic review indicated that the identified procedures (closed-controlled subcutaneous drainage, MLD, compression therapy, and CDT) are relatively safe. Nurses may consider recommending these procedures to individuals with lymphedema and advanced or metastatic cancer. Nurse scientists need to conduct more rigorously designed studies to test the effectiveness of management of cancer-related lymphedema in palliative care.

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Bechtel, T., McBride, A., Crawford, B., Bullington, S., Hofmeister, C.C., Benson Jr, D.M., . . . Devine, S.M. (2014). Aprepitant for the control of delayed nausea and vomiting associated with the use of high-dose melphalan for autologous peripheral blood stem cell transplants in patients with multiple myeloma: A phase II study. Supportive Care in Cancer, 22, 2911–2916. 

Study Purpose

To evaluate the efficacy of adding aprepitant to an antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Participants received aprepitant at 125 mg orally on day 1 followed by 80 mg orally at 24 and 48 hours after the initial dose of aprepitant. Ondansetron was given at 16 mg orally on day 1, and dexamethasone was given at at 12 mg orally on day 1 and at 8 mg orally on days 2–4. Breakthrough medications were used as needed. There was no comparison or control group. To evaluate nausea and vomiting, patients were assessed four to six times per day for the presence or absence of vomiting, the frequency of emetic episodes, the need for breakthrough antiemetic medication, and a nausea score provided by the nurse. Mean nausea scores were assessed every 24 hours beginning 24 hours after chemotherapy and continuing 120 hours after chemotherapy.

Sample Characteristics

  • N = 26  
  • MEAN AGE = 59.3 years (no range given)
  • MALES: 65%, FEMALES: 35%
  • KEY DISEASE CHARACTERISTICS: Multiple myeloma and autologous stem cell transplant
  • OTHER KEY SAMPLE CHARACTERISTICS: High-dose melphalan

Setting

  • SITE: Not specified
  • SETTING TYPE: Not specified    
  • LOCATION: Not specified

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, single-arm study

Measurement Instruments/Methods

  • Nausea scores were determined using a linear analog scale (0–10).

Results

Complete response was defined as no more than one emetic episode during the evaluation period. Of the 26 participants, 25 (96%) completely responded and needed no additional breakthrough medication. Twenty-four (92%) had no documented emetic episodes during the study period. Some degree of nausea was reported by 23 out of 26 (88%) patients, and the mean nausea score for the entire group during the study period was 0.7 (range = 0–10).

Conclusions

Adding aprepitant to a standard antiemetic regimen may result in lower rates of CINV associated with high-dose melphalan and stem cell transplant.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)

 

Nursing Implications

Adding aprepitant to standard antiemetic regimens may result in better controlled CINV. However, with such a small sample size and no comparison group, attributing these results to the intervention is difficult.

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Bazire, L., Fromantin, I., Diallo, A., Lande, B., Pernin, V., Dendale, R., . . . Kirova, Y.M. (2015). Hydrosorb® versus control (water based spray) in the management of radio-induced skin toxicity: Results of multicentre controlled randomized trial. Radiotherapy and Oncology, 117, 229–233. 

Study Purpose

To report the efficacy of Hydrosorb versus water-based spray (control) to treat G1-2 radiodermatitis in patients with early stage breast cancer (BC) treated with normo-fractionated radiotherapy (RT)

Intervention Characteristics/Basic Study Process

  • Patients were randomized to either the (a) Hydrosorb arm or the (b) placebo arm if they had the presence of grade 1 or grade 2 radiodermatitis.
  • Baseline colorimetric measurement was performed on healthy skin on day 0.
  • Local placement of Hydrosorb was done by the research nurse for the first time with subsequent education on how to apply at home. 
  • Study observations were conducted on days 7,14, 21, and 28.
  • All patients were instructed in skin care: use of mild soap for cleansing and daily moisturizer, avoidance of pools and sunlight, use of razors or deodorant
  • Patients were removed from the study for grade 3 or 4 dermatitis.

Sample Characteristics

  • N = 278 in intention to treat analysis
  • MEDIAN AGE = 53 years
  • AGE RANGE = 21–86 years
  • MALES: Not stated  
  • FEMALES: Not stated
  • KEY DISEASE CHARACTERISTICS: All patients had breast cancer. Three patients in the Hydrosorb arm had diabetes (2.1%), and six patients in the placebo group (4.4%).
  • OTHER KEY SAMPLE CHARACTERISTICS: Age, body mass index, tobacco use, diabetes, neoadjuvant chemotherapy, radiodermatitis grade, median dose, medial colorimetric value, colorimetric value in two categories, median surface, pain, concurrent hormonal treatment

Setting

  • SITE: Multicenter
  • SETTING TYPE: Hospital
  • LOCATION: France

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Study Design

Randomized, prospective, open-label, placebo-controlled study

Measurement Instruments/Methods

  • Dermatology Life Quality Index (DLQI) questionnaire 
  • Colorimetric evaluation (chromameter)
  • Visual analog scale (VAS) 
  • Common Terminology Criteria for Adverse Events (CTCAE), version 3

Results

  • Sixty (49%) treatment interruptions/failures occurred in Hydrosorb arm versus 62 (51%) in the control arm (p = 0.58).
  • Twenty-four patients discontinued RT for local care.
  • No colorimetric difference existed between the two arms (p = 0.21).
  • The average absolute reduction of colorimetric levels between day 28 and day 0 was 4. 
  • The median surface area of radiation dermatitis zone on D28 was 4.04 (Hydrosorb) and 4 (placebo).
  • The median VAS on D28 was 2 in both arms.
  • Forty-eight patients in the Hydrosorb arm had a VAS score greater than 2 versus 51 patients in the placebo arm (i.e., 34% and 38%, respectively) (p = 0.45).
  • Significant reduction of pain was observed on D7 (p = 0.04) and D21 (p = 0.01) in the Hydrosorb arm.
  • Median quality of life (QOL) per DLQI on D28 was 5 in both arms.
  • Sixty patients in the Hydrosorb arm and 55 patients in the placebo arm had moderately to severely altered QOL (p = 0.76).
  • Skin care was considered to be satisfactory for 125 patients in the Hydrosorb arm (88%) and 116 patients in the placebo arm (85%) (p = 0.059).

Conclusions

No significant difference existed between Hydrosorb and placebo in the treatment of acute radioinduced dermatitis. A trend in improvement in pain was observed with the use of Hydrosorb; however, any additional treatment given for pain, which was allowed, was not described.

Limitations

The ingredients of the patients' applied moisturizer were not defined and could have altered skin physiology in both arms. The frequency of Hydrosorb application was not defined. No actual grading of dermatitis existed per se. Changes in local treatment were allowed, but no information was provided regarding what additional treatments were done.

Nursing Implications

This study did not show that Hydrosorb was effective in preventing the increase of radiodermatitis severity. Patient instructions used here included outdated information, such as the need to avoid use of deodorants. Very limited evidence shows that topical treatments effectively prevent radiodermatitis.

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Bauters, T.G., Verlooy, J., Robays, H., Benoit, Y., & Laureys, G. (2013). Emesis control by aprepitant in children and adolescents with chemotherapy. International Journal of Clinical Pharmacy, 35, 1021–1024. 

Study Purpose

To investigate the efficacy of aprepitant in children and young adolescents receiving highly or moderately emetogenic chemotherapy who experienced uncontrollable emesis in previous cycles

Intervention Characteristics/Basic Study Process

This was a retrospective, observational analysis in children and adolescents aged greater than three years treated with aprepitant at a hospital in Belgium. Patients were identified through pharmacy records. Data on the use of antiemetics and emesis control were retrieved from pharmacy and nursing files. Emesis was defined as at least one episode of vomiting during the current chemotherapy cycle. Complete vomiting control was defined as no vomiting during the current cycle while incomplete control was defined as at least one episode of vomiting. The use of aprepitant was recorded and analyzed for each patient and for every chemotherapy cycle in which aprepitant was given.

Sample Characteristics

  • N = 20  
  • AVERAGE AGE = 14 years (range = 8–16 years)
  • MALES: 55%, FEMALES: 45%
  • KEY DISEASE CHARACTERISTICS: Bone tumor, lymphoma, leukemia, malignant mesenchymal tumor, germ cell tumor, hepatocellular carcinoma, and relapsed nephroblastoma and neuroblastoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Two patients were younger than than 11 although aprepitant is used in patients older than 11.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Ghent University Hospital in Belgium

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Pediatrics

Study Design

Retrospective, observational analysis over three years 

Measurement Instruments/Methods

  • Demographic data, cancer type, chemotherapy treatment protocol, emetogenic level of the chemotherapy cycle, administration of antiemetics, and emesis control over 24 hours, after 24 hours, and overall were recorded.
  • Emesis episodes (at least one during the chemotherapy cycle) and complete vomiting control (no vomiting during the current chemotherapy cycle) were endpoints.

Results

The total data reported were for 104 episodes.
 
Complete vomiting control was observed in 89 out of 104 (85.6%) of episodes, and incomplete vomiting control was seen in 15 out of 104 episodes (14.4%). This was observed in 10 patients (50%). Of them, four experienced vomiting in the acute phase (40%) and four in the delayed phase (40%). Two patients experienced vomiting in both the acute and delayed phase (20%). In the 15 episodes of incomplete vomiting control, vomiting was observed during the acute phase in six episodes (40%), seven in the delayed phase (46.7%), and two in both the acute and delayed phases (13.3%). Eight out of 10 patients (80%) with incomplete vomiting control needed rescue therapy with alizapride (three patients [37.5%] in the acute phase, three [37.5%] in the delayed phase, and two [25%] in both the acute and delayed phases). This represented 13 (86.7%) episodes with rescue therapy, five (38.5%) in the acute phase, five (38.5%) in delayed phase, and three (23%) in both phases.

Conclusions

Half the patients, representing a sizable percentage of episodes with complete emesis control, benefited from the use of aprepitant in combination with other antiemetics. This suggested the added value of aprepitant in patients receiving moderately or highly emetogenic cycles of chemotherapy, especially as all the included patients experienced uncontrollable emesis in previous cycles. Patients or parents with a positive experience with aprepitant asked for the availability of the product in subsequent cycles, which highlights its value.

Limitations

  • Small sample (< 30) 
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)

 

Nursing Implications

Aprepitant achieved good results in preventing or reducing vomiting in children, which might improve compliance and patient and family satisfaction.

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Bausewein, C., Booth, S., Gysels, M., & Higginson, I. (2008). Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database of Systematic Reviews (Online), 2(2), CD005623.

Purpose

The objectives of the study were to

  • Determine the effectiveness of nonpharmacologic and noninvasive interventions to relieve breathlessness in patients suffering from primary and secondary cancer, chronic obstructive pulmonary disease, interstitial lung disease, chronic heart failure, and motor neuron disease
  • Find out which intervention strategies are available, which are effective, and which participant groups benefit most from which interventions.

Search Strategy

  • Databases searched were The Cochrane Central Register of Controlled Trials; MEDLINE; EMBASE; CINAHI; British Nursing Index; PsycINFO; Science Citation Index Expanded; AMED; The Cochrane Pain, Palliative, and Supportive Care Trials Register; The Cochrane Database of Systemic Reviews; and Database of Abstracts of Reviews of Effectiveness.
  • After the initial search, reference lists from key articles, texts, and websites also were searched.
  • Authors with research in progress were contacted for unpublished data.
  • Search keywords were dyspnoea, shortness of breath, breathlessness, difficulty of breathing, or laboured breathing.
  • Included were randomized controlled and controlled clinical trials, including quasi-randomised trials and trials with double-blinding assessing the effectiveness of nonpharmacologic and noninvasive interventions to relieve breathlessness in participants with advanced stages of cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), chronic heart failure (CHF), and motor neuron disease (MND).
  • Studies were excluded if they examined any invasive interventions.
  • Studies having the intervention compared against placebo or usual therapy were not included.

Literature Evaluated

  • Initially, 5,154 articles were retrieved; a final of 47 are included in this review.
  • Two review authors assessed studies identified by the search for their relevance for inclusion.
  • Breathlessness was validated by reliable rating scales such as visual analogue scales (VAS), numeric rating scales (NRS), categorical scales, and modified Borg scales.
  • The Oxford Quality Scale was used to evaluate randomization, double blinding, description of withdrawal, and dropouts.
  • The Method Score From Edwards was used for studies with less rigorous methodology.
  • The Palliative Care National Institute of Clinical Excellence (NICE) guidelines were used to assess the grade of evidence.

Sample Characteristics

The study reported on a sample of 2,532 participants in 47 studies categorized into single intervention or multi-component interventions.

Results

The following single interventions were identified.

  • Walking aids (seven studies)
  • Distractive auditory stimuli (music) (six studies)
  • Chest wall vibration (five studies)
  • Acupuncture/acupressure (five studies)
  • Relaxation (four studies)
  • Neuro-electrical stimulation (three studies)
  • Fan (two studies)

The following multi-component interventions were identified.

  • Counseling and support (six studies)
  • Breathing training (three studies)
  • Counseling and support with breathing training (two studies)
  • Case management (two studies)
  • Psychotherapy (two studies)

A meta-analysis of the included studies was not possible due to hetereogeneity of the studies. Strong evidence suggests that neurologic muscular electrical stimulation and chest wall vibrations provide helpful relief of breathlessness in patients with COPD. However, the practical implications of the chest wall vibration interventions were only conducted in the respiratory laboratory. The evidence is moderately strong for walking aids having some benefits for patients with COPD with breathlessness by reducing the work of chest muscles. Moderate strength of evidence exists for breathing training being beneficial for breathless patients. Finally, not enough evidence exists to recommend usage of acupuncture, distractive auditory stimuli, relaxation, fan, counseling and support programs, or counseling and support programs in combination with relaxation and breathing training, case management, and psychotherapy.

Conclusions

Moderate evidence strength for walking aids and breathing retraining for COPD suggests these may be helpful interventions. Applicability in patients with cancer may be worth investigation.

Nursing Implications

  • Nonpharmacologic interventions for breathlessness need further testing.
  • Studies with sufficient sample size and power calculations are needed to be applicable to palliative care settings.
  • In recent years, a significant research gap exists in cancer, ILD, CHF, and MND.
  • The effectiveness of the chest wall vibration interventions should be retested outside the respiratory lab.
  • The beneficial timing of neuro-electrical stimulation should be investigated and tested.
  • Testing for whether acupressure or acupuncture alone or together has the best relief for breathlessness in patients is needed.
  • More research is needed to study the long-term effect of nonpharmacologic interventions on ongoing problems in advanced disease until the end of life.
  • Interventions should be developed for breathlessness at rest.
  • Mixed approaches of interventions should be tested.
  • New nonpharmacologic interventions related to breathless patients in advanced disease should be tested and investigated.
Print

Bausewein, C., Booth, S., Gysels, M., Kuhnbach, R., & Higginson, I.J. (2010). Effectiveness of a hand-held fan for breathlessness: A randomised phase II trial. BMC Palliative Care, 9, 22.

Study Purpose

The objective of the study was to determine effectiveness and acceptance of use of a handheld fan to relieve breathlessness in patients with advance chronic obstructive pulmonary disease (COPD) and cancer.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the fan or control groups. Control patients were given a wristband and instructed to wear it constantly and pull it at short intervals when breathless. Patients in the intervention group were given a handheld fan, shown how to use it (aimed at the central part of the face), and given a booklet with instructions for use. Data were collected at baseline and by monthly postal questionnaires for six months or until the patient died.

Sample Characteristics

  • The study reported on a sample of 36 evaluable patients.
  • The mean age was 65.6 years (SD = 8.8 years).
  • Of the sample, 51% were males and 49% were females.    
  • Thirty percent of patients randomized had advanced cancer.
  • The number of those completing the trial is not described.
  • Types of cancer are not described.

Setting

The study was conducted in an unspecified single site in the United Kingdom.

Phase of Care and Clinical Applications

  • Patients were undergoing end-of-life care.
  • The study has clincal applicability for end-of-life and palliative care.

Study Design

The study was a randomized controlled trial.

Measurement Instruments/Methods

A modified Borg scale was used.

Results

  • Twenty-nine percent in the intervention group and 41% in the control group initially randomized died before completion of the study, and missing data across groups were an average of 55%. 
  • After two months, no significant differences in outcomes were seen between groups.
  • Of 23 patients in the intervention group at two months, 9 considered it helpful and 14 did not. 
  • Power analysis showed that sample size at two months was sufficient to detect an effect size of 2.5, but the actual effect size seen was .08, showing no meaningful effect.

Conclusions

This study shows that use of a handheld fan for breathlessness was not effective.

Limitations

  • The study had a small sample size of less than 100.
  • The control condition used may not have been useful . 
  • This study demonstrates the difficulty in providing an appropriate control condition with nonpharmaceutical types of interventions and the difficulty in attempting to evaluate longer term results in patients with advanced disease.  
     

Nursing Implications

Findings do not show any benefit of a handheld fan to help patients with the sensation of breathlessness.

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Baumann, F.T., Zopf, E.M., Nykamp, E., Kraut, L., Schüle, K., Elter, T., . . . Bloch, W. (2011). Physical activity for patients undergoing an allogeneic hematopoietic stem cell transplantation: Benefits of a moderate exercise intervention. European Journal of Haematology, 87, 148–156.

Study Purpose

To demonstrate the effects of an exercise program on endurance, strength, lung function, and quality of life in patients undergoing allogeneic transplantation.

Intervention Characteristics/Basic Study Process

Forty-seven patients undergoing allogeneic transplantation during a three-year period were recruited and randomized into either the exercise group (EG) or the control group (CG). The EG received daily aerobic endurance training with a cycle and ADL training, involving relaxation, stair climbing coordination, and strengthening. Exercise was done 20–30 minutes per day, twice daily. CG patients received standard physiotherapy for 20 minute five days per week, consisting of active and passive mobilization with low intensity. Fatigue measurement was conducted two days after admission and one day before discharge. Exercise began the first day after transplantation.

Sample Characteristics

  • N = 33
  • MEAN AGE: EG 41.41 years, CG 42.81 years
  • MALES: EG 6%, CG 3%; FEMALES: EG 3.5%, CG 7%
  • KEY DISEASE CHARACTERISTICS: Patients with malignant hematologic disease undergoing bone marrow transplantation
 

Setting

  • SITE: Single site  
  • SETTING: Inpatient
  • LOCATION: Center of Transplantation in Idar-Oberstein, Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

  • RCT

Measurement Instruments/Methods

  • Modified WHO test on a cycle ergometer (aerobic endurance)
  • Digimax2000-load cell (strength) 
  • Vital capacity, forced vital capacity (lung function)
  • EORTC-QLQ C30 (quality of life)

Results

Increase in the experience of fatigue in the CG. Deterioration of physical function was seen in both study groups. There was improved emotional state for patients in the EG (p = .028). Relative endurance improved in EG both groups. There was no significant group by time effect on fatigue. No effect for strength, lung function, or anthropometric assessments reached significance in either group.

Conclusions

The only significant difference between the two groups was found in relative endurance in favor of EG.

Limitations

  • Small sample (< 30)
  • Patients, therapists, and outcome assessors were not blinded to the groups.  
  • Some patients in the CG exercised on the cycle ergometers that were used in the EG.
  • It was stated that exercise would not be done if patients were unable to participate due to clinical condition, etc., but no information is provided regarding the actual percent who were able to adhere to the exercise schedule.

Nursing Implications

Physical activity during acute phase of transplantation appears safe and can improve physical endurance and strength.

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Baumann, F.T., Drosselmeyer, N., Leskaroski, A., Knicker, A., Krakowski-Roosen, H., Zopf, E.M., & Bloch, W. (2011). 12-week resistance training with breast cancer patients during chemotherapy: Effects on cognitive abilities. Breast Care, 6, 142–143.

10.1159/000327505

Study Purpose

 To evaluate the effectiveness of resistance training on cognitive abilities in patients with breast cancer undergoing neoadjuvant chemotherapy   

Intervention Characteristics/Basic Study Process

The intervention group (IG) participated in 60 minutes of resistance training (three sets of 8–12 reps for 10 different exercises at 55%–75% maximum effort) twice a week for 12 weeks. The control group (CG) did not receive any information. Cognitive evaluations were performed in the IG prior to them receiving the intervention and at study conclusion (one to two weeks after end of chemotherapy) for both groups.

Sample Characteristics

  • The total number of participants was 17 (9 in intervention group, and 8 in thecontrol group). 
  • The mean age for the IG was 46.6 years (+/- 6.9 years). The mean age for the CG was 52 years (+/- 5.5 years).
  • The percentage of males and females was not provided.
  • Participants had been diagnosed with stage I–III breast cancer and were receiving neo-adjuvant chemotherapy.

Setting

  • Site was not specified.
  • Patients were recruited from the Breast Center of the University Hospital of Cologne, Germany.

Phase of Care and Clinical Applications

Patients were undergoing active treatment.

Study Design

Prospective, non-randomized controlled trial

Measurement Instruments/Methods

  • Memo memory test (verbal memory)     
  • Wilde Intelligence subtest (working memory)
  • d2 Test of Attention (focused attention and concentration)

Results

The IG's d2 Test of Attention scores improved (p = 0.049), but no significant differences were observed in comparison to the CG. The IG d2 error rate decreased from baseline by 1.12 points (p = 0.017) but was significantly different from the CG at baseline (p = 0.040) and post-intervention (p = 0.019). The IG short-term verbal memory was marginally improved from baseline (p = NS) but was significantly better than CG scores (p = 0.048). IG Wilde test scores for working memory showed significant improvement from baseline (p= 0.049), but no significant difference existed between IG and CG scores.

Conclusions

Improvements were seen in focused attention and concentration, working memory, and verbal memory for the IG. Although no differences were observed in verbal memory and attention between the IG and CG, the CG did not have baseline evaluations performed for adequate group comparisons.  

Limitations

  • The sample size was less than 30.
  • The sample was not randomized.
  • No pre-test was conducted for the CG.
  • No comparative demographics were collected (e.g., education, occupation, information on treatment, previous treatment modalities). 
  • No actual scores or data were presented in the research brief. 

Nursing Implications

Benefits of physical activity, predominately aerobic exercise, have improved symptoms of fatigue, sleep disturbances, affect, and cognitive function. Using resistance training may improve short-term verbal memory, working memory, attention, and concentration. Further study is warranted.

Print

Bauer, C., Laszewski, P., & Magnan, M. (2015). Promoting adherence to skin care practices among patients receiving radiation therapy. Clinical Journal of Oncology Nursing, 19, 196–203. 

Study Purpose

To optimize patient adherence to Oncology Nursing Society's (ONS's) Putting Evidence Into Practice (PEP) recommendations for skin care and to evaluate associated satisfaction and skin condition

Intervention Characteristics/Basic Study Process

A skin care protocol was developed, including cleansing, use of a moisturizer, protection from the sun, and avoidance of skin friction. Patients were given written instruction sheets and videos, skin care kits were provided free of charge and nurses rehearsed to provide consistent verbal information. Outcomes measured included adherence, patient satisfaction, and skin condition. Teaching was reinforced in week 1 and 3. Adherence and skin condition were measured weekly. Results were compared to a cohort of patients who had been managed under a previous protocol. A random selection of patients who had received previous care was selected for comparison.

Sample Characteristics

  • N = 86, 30 on the new protocol
  • MEAN AGE = 59.2 years
  • MALES: 72%, FEMALES: 28%
  • KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Detroit

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Observational cohort comparison

Measurement Instruments/Methods

  • MOSAIQ ONS rating scores 0–4 for skin changes
  • Visual analog scale (VAS) for satisfaction
  • Structured interview for adherence
  • Common Terminology Criteria for Adverse Events (CTCAE)

Results

The onset of skin reactions was later among the new protocol group, but differences from previous care were not significant. By week 5, the proportion of patients with grade 3 and 4 was lower among patients in the current protocol. Adherence to skin cleansing and moisturizing was 93%–95%. Of the patients, 87% were extremely satisfied with the education they received.

Conclusions

The findings suggest that teaching patients to follow a consistent skin care protocol can be beneficial in the prevention of severe radiodermatitis.

Limitations

  • Small sample (< 100)
  • 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)
  • Key sample group differences that could influence results
  • Skin care provided to the comparison cohort is not described.  
  • The dose and fractionization of radiation therapy in both study groups are not described.
  • How many patients were also receiving radiation therapy is unclear.

Nursing Implications

Regular skin cleansing during radiation therapy is a recommended part of care. This study showed that a nursing educational and care protocol could facilitate patient compliance to skin cleansing and other aspects of skin care, and may improve patients' skin condition during radiation therapy.

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