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Caplinger, J., Royse, M, & Martens, J. (2010). Implementation of an oral care protocol to promote early detection and management of stomatitis. Clinical Journal of Oncology Nursing, 14, 799–802.

Purpose & Patient Population

To observe the benefits of implementing an oral care protocol in the identification and treatment of stomatitis in patients with head and neck cancer receiving radiation and chemotherapy

Type of Resource/Evidence-Based Process

Databases searched were CINAHL, the Cochrane Central Register of Controlled Trials, and Medline.

Search keywords were stomatitis, mucositis, mucous membrane, treatment protocols, clinical practice guidelines, radiation therapy, and chemotherapy.

A protocol was developed based on the literature. Nursing education was conducted regarding grading stomatitis based on World Health Organizaiton (WHO) guidelines and interventions for each grade. Patient education was developed regarding the key components of oral hygiene, along with creation of a stomatitis brochure. Chart audits were evaluated for a 20-day period pre- and post-intervention.

Results Provided in the Reference

After protocol implementation, more cases of stomatitis were identified and stomatitis was identified at an earlier stage of severity.

Guidelines & Recommendations

Protocol use gives nurses the tools to identify high-risk patients and provide treatment.

Nursing Implications

Daily oral assessment and protocol use reduces the severity of stomatitis resulting in improved patient outcomes. This project could have been expanded and carried one step further by looking at both patients' and nurses' satisfaction and perceived effectiveness of the program.

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Cantarero-Villanueva, I., Fernández-Lao, C., Cuesta-Vargas, A. I., Del Moral-Avila, R., Fernández-de-Las-Peñas, C., & Arroyo-Morales, M. (2013). The effectiveness of a deep water aquatic exercise program in cancer-related fatigue in breast cancer survivors: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 94, 221–230.

Study Purpose

To examine the effectiveness of an eight-week aquatic exercise program on cancer-related fatigue and physical and psychological outcomes in patients with breast cancer.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to exercise groups or usual care control groups. The intervention consisted of an eight-week program of water-based exercises, three times per week, in a heated deep swimming pool. Sessions lasted 60 minutes each and included a warm-up and cool-down. Exercise intensity was maintained according to recommendations for moderate exercise as stated by the American College of Sports Medicine and American Heart Association. Groups of 10 to 12 women participated in the exercise program. Data were collected at baseline, eight weeks, and six months.

Sample Characteristics

  • The sample was comprised of 61 participants.
  • Mean participant age was 48 years.
  • All participants were female.
  • All participants had breast cancer. 
  • The majority had undergone radiation and chemotherapy after surgery. 
  • All had completed treatment other than ongoing hormone therapy.
  • Of the participants, slightly more than 60% were married and 70% to 75% were postmenopausal.
  • At baseline, all patients reported 32 to 38 minutes of activity per day. 
  • All had completed treatment within the previous 18 months.

Setting

  • Single site
  • Outpatient
  • Spain

Phase of Care and Clinical Applications

Patients were undergoing the transition phase after active treatment.

Study Design

This was a single-blind, randomized, controlled trial.

Measurement Instruments/Methods

  • Piper Fatigue Scale
  • Profile of Mood States (POMS)
  • Multiple sit-to-stand test
  • Trunk curl static endurance test

Results

  • ANOVA showed a significant difference in all dimensions of fatigue and overall fatigue over time, between groups, with greater improvement in fatigue in the aquatic exercise group (p < 0.001). The overall effect size for total fatigue was d = 1.51 (95% confidence interval [CI] [1.13, 1.90]) at eight weeks. The overall effect size for severity of fatigue was d = 0.68 (95% CI [1.14, 1.22]). The intergroup effect size for total fatigue at six months was d = 0.87 (95% CI [0.48, 1.26]).
  • Leg and abdominal muscle endurance for the sit-to-stand and abdominal curl tests was significantly higher in patients in the exercise group (p < 0.001).
  • Groups showed a significant difference over time in favor of exercise (p = 0.029).
  • The six-month follow-up revealed no effect of exercise on depression.

Conclusions

Deep-water exercise reduced fatigue, provided a short-term improvement in leg and abdominal muscle endurance, and resulted in some short-term reduction in depression. Effects on muscle endurance and depression declined after the eight-week program. Apparent effects on fatigue lasted six months.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • The study had a risk of bias due to lacking an appropriate attentional control condition.
  • Unintended interventions or applicable interventions not described would influence results.
  • The authors either did not know the components of patients' ongoing physical activities or did not describe them.
  • The authors provided no information about adherence to the exercise program.
  • The authors did not present an intention-to-treat analysis.
  • The sample was very homogeneous, which limited the generalizability of the study.
  • The authors did not address whether the exercise itself or involvement in group activity affected depression. 

Nursing Implications

The study adds to the large body of evidence showing the effectiveness of various types of exercise in the treatment of fatigue in patients with breast cancer. Nurses can recommend various types of exercise for their patients.

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Cannici, J., Malcolm, R., & Peek, L. A. (1983). Treatment of insomnia in cancer patients using muscle relaxation training. Journal of Behavioral Therapy and Experimental Psychiatry, 14, 251–256.

Intervention Characteristics/Basic Study Process

The intervention consisted of individual muscle relaxation training over three sessions plus instructions for home practice twice daily. Patients were either in the relaxation (n = 15) or usual care (n = 15) group. The outcome was sleep.

Sample Characteristics

  • The sample was comprised of 30 patients (11 men, 19 women).
  • Mean age was 56 years (range 21–80).
  • Patients had various cancers.

Setting

  • Quiet office in the hospital, patient’s home, or patient’s hospital room
  • Southeastern United States

Phase of Care and Clinical Applications

Patients were undergoing the active treatment and long-term follow-up phases of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

Daily diary and questionnaire pertaining to sleep behavior the previous night, for a total of nine nights

Results

Sleep-onset latency was reduced in the relaxation group compared with the usual care group; differences in sleep latency were maintained at the three-month follow-up. No differences were found in other sleep variables.

Limitations

  • Sleep was measured by self-reports.
  • Training is needed in delivering muscle relaxation.

Nursing Implications

No cost issues existed.

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Cankurtaran, E. S., Ozalp, E., Soygur, H., Akbiyik, D. I., Turhan, L., & Alkis, N. (2008). Mirtazapine improves sleep and lowers anxiety and depression in cancer patients: superiority over imipramine. Supportive Care in Cancer, 16, 1291–1298.

Study Purpose

To compare the effectiveness of two psychotropic medications, mirtazapine and imipramine, on distressing somatic symptoms (i.e., pain, nausea, vomiting, decreased appetite, and sleep disturbance) of cancer as well as symptoms of depression and anxiety.

Intervention Characteristics/Basic Study Process

Patients self-selected to receive psychotropic medication and supportive psychotherapy (intervention group) or supportive psychotherapy only. Those who elected to take medication were randomly enrolled to receive mirtazapine or imipramine. Mean dosage of mirtazapine ranged from 5 to 30 mg/day, depending on the visit. Mean dosage of imipramine ranged from 5 to 100 mg/day, depending on the visit. Each group was then assessed at three visits:  baseline and three and six weeks after therapy had begun.

Sample Characteristics

  • The sample was comprised of 53 patients with cancer (35%–38.5% male, 61.5%–65% female).
  • Median age was 43 to 47.5 years (range 26–56).
  • All cancer types were included; no information about cancer stage was provided. 
  • In each group, median time since diagnosis ranged from 6.5 to 8 months.
  • All patients had an additional psychiatric diagnosis. All had cancer; were undergoing chemotherapy; and had been diagnosed with major depressive disorder, adjustment disorder, and/or anxiety disorder.

Setting

  • Single site
  • Outpatient
  • Large oncology research and training hospital in Turkey

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a prospective, repeated measures design.

Measurement Instruments/Methods

  • Patient sociodemographic information    
  • Pain, nausea, and vomiting (evaluated by single-symptom scale)
  • Weight
  • Appetite (evaluated by single item)
  • Hamilton Rating Scale for Depression (HRSD) (three items to assess sleep disturbance)
  • Hospital Anxiety and Depression Scale (HADS), Turkish version

Results

  • Among the three visits, no significant differences were observed with regard to the degree of pain, nausea, vomiting, or appetite in the mirtazapine, imipramine, and control groups, and nor did differences exist in terms of the scores relating to the degree of pain, nausea, vomiting, appetite, weight, or insomnia, among the mirtazapine, imipramine, and control groups.
  • In the mirtazapine group, the initial, middle, and late insomnia scores improved between the first and second and first and third visits. In the control and imipramine groups, no significant change occurred in insomnia scores between visits.
  • In the imipramine group, a significant difference was seen in weight at the three visits. Median weight decreased from the second to third visit.
  • In the mirtazapine group, statistically significant differences were noted in the mean total, anxiety, and depression HADS scores at each visit. Especially notable were score changes between the first and second visit. In the imipramine and control groups, no differences were found in the total, anxiety, and depression HADS scores across visits. 

Conclusions

Mirtazapine is effective in resolving insomnia and in reducing the symptoms of anxiety and depression in patients with cancer who have depression, anxiety, or adjustment disorders.

Limitations

  • The study had a small, heterogeneous sample, with less than 100 patients.
  • The study had a high drop-out rate; by six weeks, 10 of 20 patients had dropped out of the control group, 4 of 20 had dropped out of the mirtazapine group, and 4 of 13 had dropped out of the imipramine group.
  • The study had no control group or random assignment and presented no information about confounding factors. 
  • Patients were not controlled for use of concomitant medications to treat the somatic symptoms being evaluated.

Nursing Implications

Mirtazapine may be useful in treating anxiety, depression, and insomnia in patients undergoing chemotherapy for cancer who have clinically relevant anxiety or depression. More systematic research, such as placebo-controlled studies, is required.

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Cangiano, C., Laviano, A., Meguid, M.M., Mulieri, M., Conversano, L., Preziosa, I., & Rossi-Fanelli, F. (1996). Effects of administration of oral branched-chain amino acids on anorexia and caloric intake in cancer patients. Journal of the National Cancer Institute, 88, 550–552.

Study Purpose

To evaluate the efficacy of oral branched-chain amino acids versus placebo on anorexia and food intake in patients with cancer

Intervention Characteristics/Basic Study Process

A mixture of 4.8 g branched-chain amino acids was administered three times daily versus placebo powder three times daily for 60 minutes before each meal for seven consecutive days.

Sample Characteristics

  • The initial sample included 28 patients; attrition of 3 patients occurred secondary to early surgery not related to study (treatment arm = 13,  placebo arm = 12).
  • Groups were equivalent in sex, age, and tumor origin.
  • Patients were included in the study if they were newly diagnosed with cancer, undergoing surgical resection, experiencing anorexia, and not losing weight.
  • None of the patients received radiotherapy or chemotherapy during the study or four weeks prior.

Setting

Multiple institutions in Italy that were not listed or further described

Study Design

A double-blinded, placebo-controlled, randomized trial design was used.

Measurement Instruments/Methods

  • Nutritional status prior to and at end of study using biochemical indices
  • Daily caloric intake measured by weighing food before and after each meal
  • Presence of anorexia measured using questionnaire not described in the article
  • Blood tests on days 0, 3, and 7 to measure levels of plasma amino acids and tryptophan

Results

Nutritional status was within normal limits for both groups prior to and at the end of study. Daily caloric intake was significantly increased in the treatment arm. There was no change in the placebo group. Incidence of anorexia was significantly decreased in the treatment arm (100% prior to and 45% at the end of study). There was no significant change in the placebo arm (100% prior to and 84% at the end of study). Blood tests showed a significant increase in plasma amino acid levels and a decrease in free tryptophan levels in the treatment arm and no change in levels noted in the placebo arm.

Limitations

  • The study had a small sample size.
  • Inclusion criteria was fairly narrow, including newly diagnosed, resectable patients who were not losing weight. Whether results can be applied to patients with cancer not meeting these criteria is questionable.
  • The study had a short treatment time of seven days, leading to questions regarding long-term effects.
  • The measurement tool used for anorexia was a questionnaire not described in this paper but rather referenced from a previous article.
  • Anorexia was not defined.
  • The study sites were not listed or described.
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Candy, B., Jones, L., Goodman, M.L., Drake, R., & Tookman, A. (2011). Laxatives or methylnaltrexone for the management of constipation in palliative care patients. Cochrane Database of Systematic Reviews, 1, CD003448.

Purpose

To update the information available on the effectiveness of laxatives and methylnaltrexone for constipation management in palliative care patients.

Search Strategy

Databases searched were MEDLINE and the Cochrane Central Register of ControlLed Trials (Central).

Search keywords were laxatives, methylnaltrexone, and palliative care.

Studies were included in the review if

  • They reported on adults receiving palliative care.
  • Patients used laxatives or methylnaltrexone for constipation.

Studies were excluded if they reported on healthy volunteers, drug misuse–related constipation, or bowel obstruction.

Literature Evaluated

A total of 186 references were retrieved. If citation screening did not identify whether a study was eligible, the full text was reviewed for acceptability. Two authors independently screened studies and discussed differences of opinion. Randomized controlled clinical trials were evaluated for inclusion.

Sample Characteristics

  • Seven studies comprising a total of 616 patients were included.
  • Key characteristics were use of lactulose, senna, co-danthramer, misrakasneham,  and magnesium hydroxide with liquid paraffin.

Phase of Care and Clinical Applications

  • Patients were undergoing the end-of-life phase of care.
  • The study has clinical applicability for palliative care.

Results

  • The best laxative for this patient population is unclear.
  • Methylnaltrexone is effective in patients with opioid-induced constipation.

Conclusions

Well-designed clinical trials are needed to help identify which laxatives are most effective for palliative care patients with constipation.

Limitations

Very few clinical trials effectively evaluated the use of laxatives in this patient population.

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Candy, D., & Belsey, J. (2009). Macrogol (polyethylene glycol) laxatives in children with functional constipation and faecal impaction: A systematic review. Archives of Disease in Childhood, 94, 156–160.

Purpose

To determine whether more precise guidance can be given regarding use of osmotic laxatives, and to assess the evidence for their use in children with constipation.

Search Strategy

Databases searched were PubMed, Embase, the Cochrane Library, and Google Scholar. Reference lists were also hand searched.

Search keywords were polyethylene glycols, lactulose, senna, bisacodyl, picosulphate, constipation, defecation, cathartics, infant, child, preschool, adolescent, and clinical trial.

Studies were included in the review if they

  • Were a randomized clinical trial of osmotic laxative versus placebo or an active comparison
  • Reported on patients aged younger than 18 years with a diagnosis of constipation of more than three months in absence of structural, endocrine, or metabolic disease
  • Recorded a quantitative effect on constipation
  • Were published in a peer-reviewed journal.

Literature Evaluated

Initial searching provided 100 clinical trials and 71 review articles. A final group of seven trials was identified for consideration in this review.

Sample Characteristics

The seven final studies encompassed data on 594 patients.

Results

  • A consensus appears to exist among studies that PEG is more effective than lactulose.
  • One systematic review in 2006 found no evidence to support use of stimulant laxatives or bulk-forming agents among children.
  • One study compared PEG 3550 with milk of magnesia. No difference existed between groups regarding bowel movements; however, more children refused treatment with milk of magnesia than with PEG (35% versus 5%, p < 0.001).

Conclusions

The review highlights the necessity of considering what treatment children will accept in managing symptoms.

Nursing Implications

This review was done in children with functional constipation, so findings may not be clearly applicable in children with constipation related to cancer treatment. PEG may be helpful and more effective than lactulose in the management of constipation in children with cancer, and may be more accepted than milk of magnesia.

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Candy, B., Jones, L., Larkin, P.J., Vickerstaff, V., Tookman, A., & Stone, P. (2015). Laxatives for the management of constipation in people receiving palliative care. Cochrane Database of Systematic Reviews, 5, CD003448. 

Purpose

STUDY PURPOSE: To update the review of information regarding the effectiveness of administrating laxatives for the management of constipation in people receiving palliative care
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: CENTRAL, The Cochrane Library, MEDLINE, EMBRASE, CINAHL, and Web of Science (SCI and CPCI-S) for trials to September 2014
 
INCLUSION CRITERIA: Randomized, controlled trials; adults receiving palliative care
 
EXCLUSION CRITERIA: Studies that included healthy volunteers

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 175, five studies involving 370 people
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors independently screened studies and discussed differences of opinion.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 5
 
TOTAL PATIENTS INCLUDED IN REVIEW = 370

Phase of Care and Clinical Applications

PHASE OF CARE: End-of-life care
 
APPLICATIONS: Palliative care

Results

No difference in effectiveness was demonstrated in lactulose compared with senna; senna plus lactulose compared with magnesium hydroxide plus liquid paraffin; misrakasneham compared with senna; and docusate plus senna compared with placebo plus senna.

Conclusions

The best laxatives for this patient population is unclear.

Limitations

Very few clinical trials effectively evaluated the use of laxatives in this patient population.

Nursing Implications

More RCTs are needed to help evaluate the effectiveness and improve the quality of care of patients in palliative care.

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Candy, B., Jones, L., Drake, R., Leurent, B., & King, M. (2011). Interventions for supporting informal caregivers of patients in the terminal phase of a disease. Cochrane Database of Systematic Reviews, 6, CD007617. 

Purpose

STUDY PURPOSE: To assess the effects of support interventions on the psychological and physical health of informal caregivers of patients in the terminal stage of disease

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, National Health Service Research Register, Dissertation Abstracts; a hand search of Palliative Medicine, Journal of Pain and Symptom Management, and British Journal of Psychiatry was also conducted.
 
INCLUSION CRITERIA: Evaluation of interventions that aimed to provide caregiver support in addition to usual care, including domestic or respite services, and increase coping and problem solving; psychoeducational interventions; randomized, controlled trials; adult caregivers; care recipients in advanced, terminal, or end-of-life stages
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 8,269
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Consumers and Communication Review Group guidelines used to assess risk of bias. Studies were generally of low quality with uncertain risk of bias in many aspects.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 11, 8 in meta-analysis
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,836
  • SAMPLE RANGE ACROSS STUDIES: 30–363
  • KEY SAMPLE CHARACTERISTICS: In eight trials, care recipients had terminal stage cancers; varied ethnic groups

Phase of Care and Clinical Applications

PHASE OF CARE: End-of-life care

APPLICATIONS: Palliative care

Results

Nine studies used interventions aimed to directly support the caregiver, and in five of these, the intervention was also aimed at the patient. In two trials, the aim was to indirectly support the caregiver via patient support. A meta-analysis of eight studies aimed at direct caregiver support to reduce psychological distress, in favor of the intervention (SMD = –0.15, 95% confidence interval [–0.28, –0.02], p = 0.02). Studies measuring improvement in coping or quality of life did not show any significant effect of the intervention. Two trials showed improved access to health services with the intervention, and one did not show any difference between groups in physical health outcomes of the caregivers.

Conclusions

Support interventions aimed directly at the caregiver reduced short-term psychological distress, with a small effect size, and resulted in marginal and insignificant improvements in coping and quality of life.

Limitations

  • Mostly low quality/high risk of bias studies
  • High heterogeneity

Nursing Implications

Supportive interventions provided directly to informal caregivers had small but significant positive effects on caregiver psychological outcomes.

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Can, G., Topuz, E., Derin, D., Durna, Z., & Aydiner, A. (2009). Effect of kefir on the quality of life of patients being treated for colorectal cancer. Oncology Nursing Forum, 36, E335-E342.

Study Purpose

To determine the effectiveness of kefir in preventing treatment-related gastrointestinal complaints and to determine the effects of kefir on quality of life (QOL) among patients receiving chemotherapy treatment for colorectal cancer.

Intervention Characteristics/Basic Study Process

Patients were included if they had stage II, III, or IV colorectal cancer; were 18 years or older; had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; and were receiving standard treatment with 5 FU or oral fluoropyrimidine. Patients were randomized to either the control group or the experimental (kefir) group. Kefir (500 mL) was industrially prepared by Altinkilic Company in Istanbul. Patients were instructed to use 250 mL of kefir two times per day for one week during chemotherapy treatment. Side effects of treatment were evaluated in both groups one week after each chemotherapy cycle. QOL was evaluated after the third and sixth cycles of treatment.

Sample Characteristics

  • The sample was comprised of 37 patients (65% male, 35% female).  
  • Mean age was 54.32 years (standard deviation = 12.77 years).
  • Patients had colorectal cancer stage II to IV.
  • Of the patients, 29 (78%) were married.

Setting

  • Single site 
  • Istanbul University Oncology Institute

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Memorial Symptom Assessment Scale (MSAS)    
  • Functional Assessment of Cancer Therapy–General (FACT-G):  A Turkish version of the FACT-G was validated in this study by the authors. Cronbach's alpha values for subscales varied from 0.69 to 0.76, with a value of 0.9 for the total scale.

Results

There were no statistically significant differences between groups in patients’ disease-related complaints before the intervention. No statistically significant changes were observed between pre- or posttreatment for the control group for the MSAS-GDI subscale scores; however, statistically significant increases in symptom distress (p < 0.05) were observed in the experimental (kefir) group from pre- to posttreatment. For the MSAS-PHYS subscale, the control group experienced a significant increase in symptoms over pretreatment scores (p < 0.05); however, a significant increase occurred in physical symptoms after each treatment cycle (p < 0.05) in the experimental group, with physical scores significantly higher (p = 0.03) in the experimental group after the fifth cycle compared to the control group. Scores for the MSAS-PSYCH were also significantly higher (p = 0.01) in the experimental group compared to the control group after the sixth treatment cycle. Total MSAS scores were significantly higher for each treatment cycle compared to pretreatment for the experimental group (p < 0.05) and were significantly higher than the control group after the fifth treatment cycle (p = 0.02). The experimental group reported significantly fewer problems sleeping than the control group after all rounds of chemotherapy (p = 0.05). No significant differences were observed between groups for QOL (p > 0.05).

Conclusions

The kefir intervention did not affect QOL. Patients receiving kefir reported increased physical and psychological systems and increased symptom distress compared to patients not receiving kefir but reported fewer problems sleeping.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • The approach to sleep measurement was limited.

Nursing Implications

Kefir may increase physical complaints, including gastrointestinal complaints, in patients with colorectal cancer receiving chemotherapy. Kefir does not have a significant effect on QOL. Further study is needed to determine the effects of kefir on sleep problems in this population.

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