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Cramer, H., Lange, S., Klose, P., Paul, A., & Dobos, G. (2012). Yoga for breast cancer patients and survivors: A systematic review and meta-analysis. BMC Cancer, 12, 412.

Purpose

STUDY PURPOSE: To assess the evidence for effects of yoga on quality of life and psychological health in patients with breast cancer and survivors

TYPE OF STUDY:  Meta analysis and systematic review

Search Strategy

DATABASES USED: Medline, PsycINFO, EMBASE, CAMBASE, and Cochrane Library through 2/2012

KEYWORDS: Yoga, quality of life, mental health, psychological health, anxiety, depressive disorder, stress, distress, and terms for breast cancer

INCLUSION CRITERIA: Randomized controlled trial (RCT) of patients older than 18 with history of breast cancer; assess health-related quality of life (QOL) or well-being; mental, physical, function, social, or spiritual well-being; and/or psychological health

EXCLUSION CRITERIA: Studies that included yoga as part of a larger intervention, such as mindfulness-based stress-reduction, were excluded.

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 156

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used, and study quality was evaluated using Cochrane risk of bias criteria.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED: N = 12
  • TOTAL PATIENTS INCLUDED IN REVIEW: N = 742

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Program length and intensity varied from daily interventions for one week to interventions weekly for six months. Four studies included an attention-control condition. Risk of bias was generally high. Meta-analysis showed moderate short-term effects of yoga on global health-related QOL (SMD = 0.62, p = .04). Large short-term effects were found for anxiety (SMD = -1.51, p < .01), depression (SMD = -1.59, p < .01), and distress (SMD = -0.86, p < .01). None of these effects were maintained at long-term follow-up. There was significant heterogeneity in analysis of all outcomes except for overall mental, social, and spiritual well-being. Analysis showed that significant overall effects were only seen among studies involving yoga during active anticancer treatment.

Conclusions

Yoga may have short-term benefit for patients for overall QOL, anxiety, depression, and general distress; however, these effects do not appear to be maintained. It appears that benefit may be mainly seen during the active treatment phase of care.

Limitations

  • Small overall number of studies that could be included in various meta-analyses
  • High risk of bias in studies
  • High heterogeneity
  • Highly varied interventions
  • Samples limited to patients with breast cancer

Nursing Implications

Participation in activities such as yoga during treatment may help patients with anxiety, distress, and depression and overall quality of life during active treatment. The optimum frequency and duration of this type of intervention is unclear, and variability and study limitations make showing strong support of this intervention difficult. Yoga has been shown to be safe for patients with cancer; thus, for those patients who are interested in participating in yoga, there does not appear to be any reason to avoid it. Further well-designed research in this area is warranted to continue to explore the most effective timing, duration, and approaches for yoga interventions.

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Cramer, H., Lauche, R., Klose, P., Dobos, G., & Langhorst, J. (2014). A systematic review and meta-analysis of exercise interventions for colorectal cancer patients. European Journal of Cancer Care, 23, 3–14.

Purpose

STUDY PURPOSE: To evaluate the effects of exercise on patients with colorectal cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed, Cochrane Collaboration, Scopus
 
INCLUSION CRITERIA: Randomized, controlled trial; adult patients; comparison of exercise interventions with no treatment or active treatment; assessment of quality of life, fatigue, fitness, survival or biomarkers
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 415 studies
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Risk of selection, performance, attrition, reporting, and detection bias evaluation. Most had multiple risks of bias.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 5 studies, 2 in meta-analysis 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 238
  • SAMPLE RANGE ACROSS STUDIES: 18–102
  • KEY SAMPLE CHARACTERISTICS: All had colorectal cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

Meta-analysis of three studies showed no significant overall effect of exercise on fatigue or quality of life. Exercise was associated with improved physical fitness (p = 0.0006).

Conclusions

Exercise was shown to be effective in improving physical fitness; however, physical fitness did not have a significant effect on fatigue in patients with colorectal cancer in this study.

Limitations

  • Limited number of studies included
  • High heterogeneity
  • Low sample sizes

Nursing Implications

Exercise has been shown to improve fatigue in multiple patient groups. This review was limited by the small number of studies limiting samples to patients with colorectal cancer.

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Craft, L. L., Vaniterson, E. H., Helenowski, I. B., Rademaker, A. W., & Courneya, K. S. (2012). Exercise effects on depressive symptoms in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiology, Biomarkers & Prevention : A Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology, 21(1), 3-19.

Purpose

Evaluate the current literature on antidepressant effects of exercise in cancer survivors. Also to explore potential moderating variables related to participant, cancer and exercise characteristics.

TYPE OF STUDY Combined systematic review and meta analysis

Search Strategy

DATABASES Medline, Medline in Process, Psycinfo, Embase, CINAHL, Cochrane database, Cochrane central register of controlled trials, Allied and Complementary Medicine, Biosis Previews, Sports Discus
   

KEYWORDS  terms related to cancer, exercise, and depression    

INCLUSION CRITERIA Studies were eligible if they were a RCT of adults with cancer, compared exercise program with usual care, exercise program was chronic in nature (at least 4 weeks), reported depression pre and post  intervention, used depression inventory or clinician interview to define depression symptom, English language

EXCLUSION CRITERIA studies that used quality of life or moods scales to measure depression
Study Aims Evaluate the current literature on antidepressant effects of exercise in cancer survivors. Also to explore potential moderating variables related to participant, cancer and exercise characteristics.  
 

Literature Evaluated

TOTAL REFERENCES RETRIEVED : N =60

METHOD OF STUDY EVALUATION AND COMMENTS ON LITERATURE USED Two investigators independently reviewed articles with discrepancies resolved by consensus.

All studies included aerobic exercise with some also including strength training. Exercise programs were implemented prior to or during treatment in 47% of the studies. Interventions varied from unsupervised home based to supervised facility based with frew having mixed supervision. Intervention length ranged mostly from 4-14 weeks, with the longest being 52 weeks.  
 

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: N = 14 articles describing 15 RCTS   TOTAL SAMPLE SIZE: N =  1371   SAMPLE RANGE ACROSS STUDIES : 18-209, including exercise and control groups combined

KEY SAMPLE CHARACTERISTICS 60% (9) studies included breast cancer survivors. The average age was 51.6 years. 76.9 of those who reported race/ethnicity were Caucasian. Of those reporting cancer stage, 75% were patients with non-metastatic disease.

Phase of Care and Clinical Applications

PHASE OF CARE Active Treatment

APPLICATIONS Late Effects and Survivorship

Results

Effect size of -.22(p=0.04) was found comparing exercise group to control groups. Home based exercise had increased depressive symptoms (effect size(ES)e 0.16) compared to exercise location and facilities, laboratories, gyms (ES= -0.45, -0.77, -.014). Supervised exercise had the greatest effect (ES=-0.67) compared to mixed supervision (ES=-0.32) and unsupervised activity showed a small increase in depression (ES=0.25). Duration of greater than 30 minutes had a larger effect (ES=-.57) compared to less than or equal to 30 minutes (ES=0.01)

Conclusions

Overall, exercise had a small to moderate impact on depression symptoms which varied based on location of exercise, supervision, and duration. 

Nursing Implications

Exercise at places where patients interact with others had a greater effect size associated with reduction of depression symptoms. It would be important to recognize this when intervening with exercise. Future research should measure the significance of social interaction during exercise and depression symptoms.  Also, more work is necessary to understand if the exercise intervention improves QOL.

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Co, J.L., Mejia, M.B., Que, J.C., & Dizon, J.M. (2016). Effectiveness of honey on radiation-induced oral mucositis, time to mucositis, weight loss, and treatment interruptions among patients with head and neck malignancies: A meta-analysis and systematic review of literature. Head and Neck, 38, 1119–1128. 

Purpose

STUDY PURPOSE: To synthesize the available literature to determine the role of honey in reducing oral mucositis, time to onset of mucositis, weight loss, and treatment interruptions among patients with head and neck cancers undergoing radiation with or without concomitant chemotherapy

TYPE OF STUDY: Meta analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE Complete, CINAHL Plus, ProQuest Health and Medical Complete, Academic Search Complete, Biomedical Reference Collection Basic, PubMed, and Google Scholar
 
INCLUSION CRITERIA: Patients with head and neck cancer receiving chemotherapy with or without chemotherapy; use of wither raw, pure, or processed honey; administration of honey had to be oral, including concentrated or diluted
 
EXCLUSION CRITERIA: Nonrandomized controlled trails

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 83 abstracts; however, after refining the review of abstract, only eight articles were closely reviewed and five were included in the quantitative pooling according to the author. 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The authors stated that eight articles were closely reviewed for systematic review, but only two articles from meta-analysis. The authors did not say why only five articles were included in the summary table, and the selection rational was unclear.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 5 for meta-analysis and 8 for systematic review 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 244 (according to the authors)
  • SAMPLE RANGE ACROSS STUDIES: Author did not report each sample size, but some numbers were found in the report and a figure. According to the figure, each study had 20–33 participants per group, and it was assumed that each study had approximately 40–60 participants. However, one study used in systematic review seemed to have 131 patients in the study. Sample sizes were not reported well in this study. 
  • KEY SAMPLE CHARACTERISTICS: The authors included only randomized controlled trials with a honey intervention for patients with head and neck cancer who were receiving radiation therapy. The authors took appropriate screening procedures to select articles that met the criteria. This shrunk the sample size but resulted in more reliable results for meta-analysis.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Treatment Interruption: Treatment interruption was reported in three studies with a total sample of 140 patients. Statistical pooling yielded that the risk ratio of having a treatment interruption was significantly lower with the use of honey versus the control 0.11 (95% CI [0.02, 0.58], z = 2.6, p = 0.009).
 
Weight Loss (not meta-analysis result): Only two studies reported related to weight loss. They did not use the same reporting, and statistical pooling was not able to be conducted. Both studies showed statistical significance to show the effectiveness. In one study, the mean weight loss was 1 kg (SD = 0.35 kg) (range = 0–7 kg) for honey and 6.3 kg (SD = 0.53 kg) (range = 2–11 kg), and this was significant. Another study showed 55% static or positive weight gain in honey compared to the control (p < 0.05).
 
Peak mucositis score (not meta-analysis result): Some studies showed the benefit, but not all. 
 
Time to mucositis (not meta-analysis result): Two studies showed statistical significance, and one did not. No negative results exist to support honey use.

Conclusions

Honey was significantly better in lowering the risk for treatment interruptions and probably less weight loss but did not decrease the rate of the peak mucositis score. The results for prolonged onset of mucositis is favorable with the honey intervention in two studies, but one study did not show a significant difference.

Limitations

  • Limited number of studies included
  • No quality evaluation
  • High heterogeneity
  • Low sample sizes

Nursing Implications

The results showed that the honey intervention is effective in reducing treatment interruption. Other measures (weight loss, peak mucositis score, time to mucositis) need further meta-analysis to establish. Further well-designed research is needed to confirm the usefulness of honey preparations.

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Coyne, P.J., Wan, W., Dodson, P., Swainey, C., & Smith, T.J. (2013). A trial of Scrambler therapy in the treatment of cancer pain syndromes and chronic chemotherapy-induced peripheral neuropathy. Journal of Pain and Palliative Care Pharmacotherapy, 27, 359–364.

Study Purpose

To evaluate the effectiveness of Scrambler therapy on cancer pain, chemotherapy-induced peripheral neuropathy, neuropathic pain, and quality of life

Intervention Characteristics/Basic Study Process

Scrambler therapy is cutaneous electrostimulation that blocks the effect of pain information on the cutaneous nerves. In this study, all participants received the intervention to the affected area for 45 minutes daily for 10 consecutive days (Monday–Friday). Pain was measured before and after each intervention session.

Sample Characteristics

  • N = 39  
  • MEAN AGE = 56.5 years
  • MALES: 41%, FEMALES: 59%
  • KEY DISEASE CHARACTERISTICS: The majority of the study participants had chemotherapy-induced peripheral neuropathy (n = 33), followed by post-mastectomy pain (n = 3), postherpetic neuralgia (n = 2), and radiation-related pain (n = 1).
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants had to have pain or symptoms of peripheral neuropathy for longer than one month with an average daily pain rating of greater than 5 out of 10, or numbness that bothered the participant at least “a little bit.” Additionally, participants had to be adults with a life expectancy of longer than three months and an Eastern Cooperative Oncology Group performance status score of 0–2.

Setting

  • Setting was not described.

Phase of Care and Clinical Applications

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

Study Design

  • A repeated measures design with no control group was used to evaluate the intervention.

Measurement Instruments/Methods

  • Numerical Rating Scale (0–10) for pain
  • Brief Pain Inventory (questions 2–5 and 9)
  • Eastern Cooperative Oncology Group Chemotherapy-Induced Peripheral Neuropathy 20 scale
  • All measurements were performed pre- and post-intervention.
  • Comparisons were made between baseline day 1 and days 14, 30, 60, and 90.

Results

Improvement in pain was found at all secondary endpoints (days 14, 30, 60, 90), with a statistically significant difference in pain between baseline and day 30 (p = 0.0049) and change over time (p = 0.0002). Sensory and motor components of the chemotherapy-induced peripheral neuropathy scale also were found to improve with statistically significant sensory improvement between baseline and day 30 (adjusted p = 0.0007) and change over time (p < 0.0001). For the motor component, significant findings included improvement between baseline and days 14, 30, and 60 (adjusted p = 0.0143, 0.1035, 0.0094, respectively) and change over time (p = 0.0019). Improvements in all components of the Brief Pain Inventory were found (i.e., “interference with normal life,” which were maintained for mood, sleep, relationships, etc). Pain interference with walking was improved significantly between baseline and day 30 (p = 0.0003). Use of opioids did not change.

Conclusions

Scrambler therapy improved acute and chronic pain among patients with cancer. Additionally, it had a lasting effect three months post-treatment. Quality of life also was improved with this pain treatment. Further study is needed to determine generalizability of these findings to other patients with cancer.

Limitations

  • Small sample (less than 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)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: What opioids and dose the participants were taking during the study, who delivered the intervention, and the expense of the intervention or training needs were unclear. Additionally, findings are not generalizable to other patients with cancer because of the lack of a control group or attentional control condition and the small, heterogeneous sample.
  • Questionable protocol fidelity

Nursing Implications

Scrambler therapy appears to be a promising intervention for cancer-related pain and has no adverse effects. Because who delivers this treatment and its expense are unclear from this article, the implications to nursing are unclear. However, nurses knowing about this treatment is important because it may become a common method for treating cancer-related pain in the future.

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Coyne, P. J., Viswanathan, R., & Smith, T. J. (2002). Nebulized fentanyl citrate improves patients’ perception of breathing, respiratory rate, and oxygen saturation in dyspnea. Journal of Pain and Symptom Management, 23, 157–160.

Study Purpose

To test the theory:  \"Inhaled opioids usually are ineffective with report of respiratory depression; however, fentanyl may be more readily absorbed with less bronchospasm and thus relieve dyspnea.\"

Intervention Characteristics/Basic Study Process

Patients were given 25 mcg of fentanyl with 2 mL of saline via a nebulizer.

Sample Characteristics

  • The sample was comprised of 35 patients (20 women, 15 men) with terminal cancer who reported shortness of breath. 
  • Average age was 56 years.
  • Thirty-four patients were on oxygen. 

Setting

  • Inpatient
  • Oncology unit

Study Design

The study used a convenience sample, uncontrolled design.

Measurement Instruments/Methods

  • Patients’ perceptions of breathing (same, worse, or improved) were measured one hour after treatment.
  • Respiratory rate and oxygen saturation were measured at baseline and at 5 and 60 minutes following the intervention.

Results

  • Twenty-six of 32 patients (81%) reported improvement in breathing.
  • Three of 32 (9%) patients were unsure of their results.
  • Three of 32 (9%) patients reported no improvement.
  • Mean oxygen saturation significantly improved from 94.6% to 96.8% (p < 0.001) at five minutes and to 96.7% (p < 0.006) at 60 minutes.
  • Mean respiratory rate significantly decreased from 28.4 at baseline to 25.8 at five minutes (p < 0.03) and to 24.1 at 60 minutes (p < 0.02).

Conclusions

Fentanyl improved all three measures and may offer substantial relief of dyspnea. No significant side effects were reported.

Limitations

  • The study was not randomized and needs confirmation in a randomized, controlled trial.
  • The impact of the carrier saline is unknown.
  • Also unknown is the cause of attrition of three patients and whether patients were opioid tolerant or naïve.

Nursing Implications

Clinical questions about repeated dosing and method of administration (mask or mouthpiece) remain.

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Coyle, V.M., Lungulescu, D., Toganel, C., Niculescu, A., Pop, S., Ciuleanu, T., … Wilson, R.H. (2013). A randomised double-blind placebo-controlled phase II study of AGI004 for control of chemotherapy-induced diarrhoea. British Journal of Cancer, 108, 1027–1033.

Study Purpose

To examine the effectiveness of the use of a controlled-release transdermal patch preparation of mecamylamine (AG1004)

Intervention Characteristics/Basic Study Process

Patients who had received at least one cycle of chemotherapy and experienced grade 1 or 2 diarrhea were randomized to receive transdermal mecamylamine (AG1004) 4 mg every 24 hours or placebo using an identical-looking patch. The patch was applied 24 hours prior to chemotherapy and reapplied daily for the duration of the treatment cycle. Patients were allowed to use loperamide, codeine phosphate, or octreotide on a rescue basis for any active episodes of diarrhea. During the next cycle, the AG1004 dose was increased to 8 mg per day. Evaluation was done at the end of the first day of each cycle and at the end of the overall cycle of chemotherapy. Daily logs were used to record bowel movements and use of rescue medication.

Sample Characteristics

  • The study reported on 64 patients.
  • Mean age was 61.2 years with a range of 35–88 years.
  • The sample was 25% male and 75% female.
  • Patients had various tumor types, with colon and breast cancer most common.
  • All patients were receiving chemotherapy that has been associated with diarrhea, and all had experienced diarrhea in a previous cycle.
  • Patients were being treated with fluorouracil (5-FU), capecitabine, or irinotecan.

Setting

This was a multisite, outpatient study conducted in the United Kingdom and Romania.

Phase of Care and Clinical Applications

  • All patients were undergoing the active treatment phase of care.
  • This study has clinical applicability for elder care.

Study Design

This was a double-blind, randomized, placebo-controlled study.

Measurement Instruments/Methods

  • The Bristol stool scale and the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grading were used.
  • Patients kept daily diaries of bowel movements and use of rescue medication.

Results

  • Overall compliance with treatment was an average of 90% in both study groups.
  • Overall response (OR) was 1.26 in favor of the treatment, based on physician assessment, but this was not statistically significant.
  • Based on patient reporting of four or fewer bowel movements per day from diaries, more patients were classified as responders in the treatment group (OR = 6.4, 95% confidence interval [CI] = 1.7–24.6, p = 0.05). 
  • Use of rescue medication was low in both groups. 
  • Overall use of loperamide was less in the treatment arm at both treatment dosages, with a greater trend observed with the 8-mg dose level (p = 0.05).
  • No differences were found between groups in other associated gastrointestinal symptoms.

Conclusions

AG1004 was associated with less diarrhea compared to placebo on day one of chemotherapy cycles and did not appear to have significant adverse effects. AG1004 may be helpful in preventing chemotherapy-induced diarrhea.

Limitations

The sample size was small with fewer than 100 participants.

Nursing Implications

This study demonstrated some promising results, suggesting that treatment with AG1004 may be useful in preventing chemotherapy-induced diarrhea in patients being treated for cancer with agents known to be associated with diarrhea. Further research is warranted to confirm these findings.

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Cowan, C.C., Hutchison, C., Cole, T., Barry, S.J., Paul, J., Reed, N.S., & Russell, J.M. (2011). A randomised double-blind placebo-controlled trial to determine the effect of cranberry juice on decreasing the incidence of urinary symptoms and urinary tract Infections in patients undergoing radiotherapy for cancer of the bladder or cervix. Clinical Oncology, 24, e31–e38.

Study Purpose

The purpose of this study was to evaluate the effectiveness of cranberry juice on the incidence of urinary tract infections and urinary symptoms in patients undergoing pelvic radiotherapy for cancer of the bladder or cervix.

Intervention Characteristics/Basic Study Process

Participants were randomized to receive cranberry juice, twice a day (morning and night) for the duration of their radiotherapy treatment and for two weeks after treatment (six weeks in total) or a placebo beverage, for the same duration. The primary study end point was the percentage of patients who experienced an increase in the Common Toxicity Criteria (CTC) grade of their urinary symptoms or developed a urinary tract infection during the period of six weeks. The laboratory diagnosis of a urinary tract infection was based on a significant isolate of a single organism (i.e., 100,000 ml or heavy growth) in a non-catheterized patient and/or other abnormal findings, such as pus cells in the urine with or without subjective symptoms. Patients were required to provide weekly urine samples and to keep a daily diary to record their bladder symptoms and compliance with drinking the juice.

Sample Characteristics

  • The total sample size was 31 participants.
  • The cranberry juice group had a mean age of 67.5 years (range = 27–89); the placebo group had a mean age of 69 years (range = 28–85)
  • Fifty-three percent of the sample were male, 47% were female
  • Patients with cervical cancer made up 34.3% of the cranberry juice group (3.1% with radiotherapy alone) and 34.4% of the placebo group (4.7% with radiotherapy alone).
  • Patients with bladder cancer made up 65.6% of the cranberry juice group and 65.6% of the placebo group. 
  • Patients who had undergone previous urological surgery accounted for 31.3% of the cranberry juice group and 32.8% of the placebo group. 
  • Patient who had undergone previous gynecological surgery accounted for 28.1% of the cranberry juice group and 23.4% of the placebo group.
     

Setting

A single-site outpatient setting in Scotland


 

Phase of Care and Clinical Applications

Acute treatment

Study Design

Randomized, double-blind, placebo-controlled trial

Measurement Instruments/Methods

  • Urinary tract infections and/or pain
  • Hematuria
  • Frequency of urination
  • Patient diaries were used to record bladder symptoms and compliance with drinking juice.
  • Weekly urine samples were used to evaluate for infection
     

Results

The incidence of increased urinary symptoms or urinary tract infections was 82.5% in the cranberry juice group and 89.3% in the placebo group (p = 0.24, adjusted odds ratio [cranberry/placebo] 0.48, 95% CI [0.14, 1.63]).

Conclusions

This study did not provide support for effect of cranberry juice for prevention of urinary tract infections in this group of patients.

Limitations

  • Small sample size (less than 100 participants)
  • The power of the study to detect differences was limited by the below-target sample size and poor compliance.
  • Further research is recommended, taking cognizance of the factors contributing to the limitations of this study.
     

Nursing Implications

This study did not support effectiveness of drinking cranberry juice for prevention of urinary tract infections in patients receiving pelvic irradiation. The study had multiple limitations. No conclusions can be drawn from this study report due to limitations and small sample size.

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Courneya, K.S., Segal, R.J., Gelmon, K., Reid, R.D., Mackey, J.R., Friedenreich, C.M., . . . McKenzie, D.C. (2007). Six-month follow-up of patient-rated outcomes in a randomized controlled trial of exercise training during breast cancer chemotherapy. Cancer Epidemiology, Biomarkers and Prevention, 16, 2572–2578.

Study Purpose

Primary aim: To determine if prior research findings of improvement in patient outcomes with exercise during adjuvant chemotherapy would be maintained at six-month follow-up

Secondary aim: To determine if patients who reported regular exercise during the follow-up period would report better outcomes at six-month follow-up

Intervention Characteristics/Basic Study Process

Participants who had initially been in a three-armed randomized controlled trial were recruited to participate in this study. Prior study groups were aerobic exercise, resistance exercise, and control. Exercise groups were supervised. Participants were mailed questionnaires to determine the frequency of exercise and to rate their quality of life, self-esteem, fatigue, anxiety, and depression. Participants were asked to recall their exercise of the past six months using a questionnaire, and were then categorized into meeting or not meeting current guidelines for aerobic exercise (>/= 60 minutes of vigorous or 150 minutes of moderate exercise per week).

Sample Characteristics

  • The study reported on a sample of 201 female patients with breast cancer.
  • Mean patient age was 49 years, with a range of 25–78 years.
  • Patients received adjuvant chemotherapy with or without radiation therapy.
  • Of the sample, 21% were obese, 61% had stage II disease, 59% had breast-conserving surgery, 31% received taxane-based chemotherapy, and 25% had reported recent exercise in the initial study.

Setting

  • Multisite
  • Other setting
  • Alberta, Ottawa, and British Columbia, Canada

Phase of Care and Clinical Applications

Patients were undergoing the transition phase of care after initial treatment.

Study Design

This was a descriptive study for follow-up from a previous randomized controlled trial.

Measurement Instruments/Methods

  • Functional Assessment of Cancer Therapy–Anemia scale (FACT-A)
  • Rosenberg Self-Esteem Scale
  • Center for Epidemiologic Studies–Depression scale (CES-D)
  • Spielberger State-Trait Anxiety Inventory
  • Godin Leisure-Time Exercise Questionnaire

Results

Of the sample, 20.9% reported meeting both aerobic and resistance exercise guidelines, 8% reported meeting only resistance exercise guidelines, 28.9% reported meeting only aerobic guidelines, and 42.3% reported not meeting any exercise guidelines. Those who originally were in a group given supervised aerobic exercise training (AET) had fewer reporting that they met exercise guidelines during follow-up (p = 0.034). Those who had received resistance exercise training (RET) reported higher self-esteem at six months (p = 0.032). The AET group reported significantly lower anxiety at six months than either the control or RET group members (p = 0.049). All other changes in self-reported outcomes at six months favored the exercise groups, but were not statistically significant. Those who reported that they met exercise guidelines reported higher quality of life (p = 0.025) and less fatigue (p = 0.013). They also reported less anxiety, but this difference was not significant. At six months, those in the AET group reported that anxiety was lower by 4.7 points and depression was reduced by 2.7 points.

Conclusions

Exercise training during chemotherapy treatment may have longer-term effects on anxiety and self-esteem. Consistent exercise meeting recommended guidelines appears to benefit patients in terms of a positive effect on symptoms of fatigue and general quality of life.

Limitations

  • There was a higher loss to follow-up in the original study’s control group, which may have skewed study results comparing exercise groups to controls.
  • Findings are based on self-report only, which may have affected findings related to consistency of exercise.

Nursing Implications

Findings suggest that ongoing exercise according to guidelines appears to have positive effects on patients’ quality of life, fatigue, anxiety, and self-esteem. Nurses can educate patients about these potential benefits.

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Courneya, K.S., Segal, R.J., Mackey, J.R., Gelmon, K., Friedenreich, C.M., Yasui, Y., . . . McKenzie, D.C. (2014). Effects of exercise dose and type on sleep quality in breast cancer patients receiving chemotherapy: A multicenter randomized trial. Breast Cancer Research and Treatment, 144, 361–369.

Study Purpose

To compare the effects and doses of a three-arm exercise trial to improve sleep quality in patients with breast cancer receiving active chemotherapy

Intervention Characteristics/Basic Study Process

The three-group design of the CARE trial compared the standard dose of 25–30 minutes of aerobic exercise (STAN) to higher doses of activity that included 50–60 minutes of aerobic exercise (HIGH) and 50–60 minutes of combined-dose of aerobic and resistance exercise (aerobic and strength training three times per week) (COMB). COMB strength training was part of the 50–60 minute session and included two sets of 10–12 repetitions of nine different strength exercises at 60%–75% of the estimated one-repetition max (RM). All groups received three weekly treatments with outcomes measures to determine primary and secondary outcomes. Interventions continued for the duration of chemotherapy. Data were collected at baseline, midpoint 1, midpoint 2, and postintervention.

Sample Characteristics

  • N = 296
  • MEAN AGE = > 18 years M = 50 (SD = 8.7 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving active chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: English or French speaking; not pregnant; stages I–IIIc

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Blinded, randomized, controlled trial

Measurement Instruments/Methods

  • Primary outcomes were measured using the Pittsburgh Sleep Quality Index (PSQI).
  • Secondary outcomes for moderators for plausibility included clinical utility, support for previous research used, age, aerobic exercise guidelines, strength exercise guidelines, comorbidities, body mass index, aerobic fitness (treadmill and gas exchange), and medical moderators from records (stage, surgery, and chemotherapy).

Results

296 patients completed the study with complete data. Baseline global sleep scores were M = 6.2 (SD = 4.1) with 52% of participants reporting poor sleep at baseline (PSQI > 5). The main effects of the study showed that the HIGH group had statistically better outcomes compared to the STAN group for primary sleep global scores (d = 0.22; p = 0.039), sleep quality (d = 0.26; p = 0.028), and sleep latency (d = 0.18; p = 0.049). The COMB group barely scored significantly higher than the STAN group for global sleep quality, sleep duration, and sleep efficiency (d = 0.24; p = 0.04)  and percent of poor sleepers (d = 0.20; p = 0.045). The HIGH group was statistically better than COMB for sleep latency only (d = 0.20; p = 0.04) . Significant moderators included surgery, baseline aerobic fitness, baseline aerobic exercise guidelines, baseline strength guidelines, and number of comorbid conditions. The effect size for the HIGH group compared to the STAN group was larger for global sleep quality for lumpectomy patients with no comorbid conditions, those meeting aerobic exercise guidelines, and those who were fitter at baseline. Scores in the COMB group were higher than those of the STAN group for lumpectomy patients meeting strength exercise guidelines. The overall effect for each arm was small.

Conclusions

Higher doses of exercise and the combination of exercise and strength training were associated with better overall sleep quality compared to the standard dose of 50–60 minutes of aerobic exercise. Different sleep components appeared to be most affected by the type of exercise intervention, and no single intervention impacted all the sleep components measured.

Limitations

  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: There were no noted statistics to compare the three intervention groups as reported in the manuscript, so it is unclear whether group differences were present. The findings of this study only are generalizable to breast cancer and cannot be generalized to other active patients with cancer. The intervention assumes that patients have access to exercise support and gyms with the COMB part of the intervention. This might not be realistic for some areas with rural populations. The PSQI was validated using all 19 items, but this study eliminated nine (sleep disturbance) questions without a validation of the questionnaire, thus reducing the overall validity and reliability of the findings that were based on the global sleep quality index.

Nursing Implications

Nurses often suggest maintaining activity during treatment, but there is little information about the effectiveness of this recommendation on sleep-wake disturbances. This study provided a large sample of patients with breast cancer that narrowed down the doses needed to affect sleep. The overall results of this study suggest that exercise can improve sleep during chemotherapy treatment. However, the limitations of this study need to be taken into consideration before recommending the actual interventions used.

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