To compare the efficacy of multidose ondansetron with single-dose granisetron in complete emesis control and time spent in an ambulatory care setting in children with acute lymphoblastic leukemia (ALL) receiving moderately emetogenic cyclophosphamide-based chemotherapy

Eligible patients entered a four-week run-in period during which they were given antiemetic agents according to the randomization scheme before their scheduled IV cyclophosphamide chemotherapy. Regimens were either single-dose granisetron (0.5 mg for patients weighing 25–50 kg or 1 mg for patients over 50 kg) administered orally one hour before chemotherapy or three doses of ondansetron (0.15 mg/kg administered IV one hour before chemotherapy and again four hours after the first dose with an additional oral dose eight hours after the first dose). Parents were asked to keep a log of their child’s emetic episodes during the first 24 hours following chemotherapy. Antiemetic efficacy was assessed by the number of vomiting episodes, the need for rescue medication, and the extent of nausea and appetite loss.

• N = 33
• MEAN AGE = 7.8 years (SD = 4.9 years)
• MALES: 64%, FEMALES: 36%
• KEY DISEASE CHARACTERISTICS: Patients with ALL receiving IV cyclophosphamide
• OTHER KEY SAMPLE CHARACTERISTICS: Ages 3–18 greater than 25 kg; no pre-existing chronic nausea or vomiting; and no coadministration of corticosteroids

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

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Single-institution, randomized, open-label, two-period crossover investigation

• Parents used a self-reported diary to document the number of emesis episodes.
• No other instruments or measurements were reported.
• No information was provided on how rescue medication, nausea, or appetite loss was measured.

In the granisetron arm, 20 out of 33 patients (60.6%) experienced complete efficacy compared to 15 out of 33 patients (45.5%) in the ondansetron arm, this was not statistically significant (p = 0.227). In both treatment groups, that males were less likely to respond to antiemetic treatment than females. In the granisetron group, 100% (12 out of 12) of females versus 76.2% (16 out of 21) of males experienced complete efficacy. In the ondansetron group, 100% (12 out of 12) of females versus 81% (17 out of 21) of males experienced complete efficacy. These differences did not meet a statistical significance (p = 0.271). The cost analysis demonstrated that granisetron costs about $0.20/kg (20 mcg/kg per patient), and ondansetron costs $20.09 per 8 mg vial or $6.18 per 4 mg tablet. This equates to about $0.99/kg (0.15 mg/kg per patient). The drug cost differential between the two modalities is $0.79/kg, favoring granisetron therapy on the basis of cost.

A single prophylactic oral dose of granisetron (10–20 mcg/kg) given prior to moderately emetogenic chemotherapy was at least as safe and effective as a triple dose of ondansetron given under similar circumstances. It also was more cost effective.

• Small sample (< 100)
• Risk of bias (no blinding)
• Measurement/methods not well described
• Measurement validity/reliability questionable 
• Findings not generalizable
• Other limitations/explanation: Subjects were followed for only 24 hours. Time spent in the clinic (a reported purpose of the study) was not reported in the findings. Conversely, cost was reported in detail in the results section but was not listed as a purpose of the study.

Based on this study, a single dose of oral granisetron (10–20 mcg/kg) is as safe and effective as a triple dose of ondansetron for moderately emetogenic chemotherapy in children with ALL in the acute phase of chemotherapy-induced nausea and vomiting only. There seems to be a gender difference in antiemetic efficacy.

To evaluate the symptoms and functional limitations of patients with secondary breast lymphedema following surgical treatment and to assess the additional therapeutic benefit of Deep Oscillation when combined with manual lymphatic drainage

Patients were randomized to the treatment group or the control group. The treatment group received 12 sessions of manual lymphatic drainage supplemented by Deep Oscillation, and the control group received manual lymphatic drainage alone.

• The study sample (N = 21) was comprised of a treatment group (n = 11) and a control group (n = 10) of female patients.
• Mean age for the treatment group was 56.6 years, with a range of 41–65 years and for the control group was 62.0 years, with a range of 42–71 years.
• All patients had breast-sparing surgery for breast cancer and were at least six weeks since their last irradiation.

The study took place at a single site in Berlin, Germany.

The study used a randomized controlled trial design.

• A 10-point visual analog scale was used to subjectively assess pain, breast swelling, and the effectiveness of lymphedema treatment.
• Range of motion of shoulder was measured using the neutral-zero method for passive range of motion.
• Range of motion of cervical spine was measured using the Zebris ultrasound-based movement sensor for active cervical spine mobility.
• ScanMobile served as a mobile 3D measuring system for the breast surface area in the target region.

Patients had high pain and swelling scores at baseline. Shoulder mobility was impaired in all patients; restriction of cervical spine mobility was common at baseline and declined further in the control group. Deep Oscillation resulted in significant pain reduction in the treatment group. The subjective reported reduction of swelling was confirmed objectively by 3D measurement only in the treatment group.

Additional Deep Oscillation supplementary to manual lymphatic drainage can enhance pain alleviation and swelling reduction.

• The study sample was small, with less than 30 patients.
• Placebo effect may exist because of the use of a new technique.
• The number of treatment sessions per week was higher in the treatment group with two to three sessions per week compared to control group with only one to two sessions per week.

More attention should be paid to patients with breast lymphedema. Treatment with low-intensity and extremely low-frequency electrostatic fields could be a useful supplementary therapy in the management of patients with breast lymphedema. However, more studies with larger sample sizes are needed to duplicate the findings from this study.

To evaluate a multi-modular self-care program, Self-Care Improvement through Oncology Nursing (SCION), consisting of emesis treatment, nutritional support, counseling, and relaxation interventions to reduce anorexia, nausea, and emesis (ANE)

Patients were randomized to receive either standard care (control) or the SCION program, which included four modular, algorithm-based protocols. In the intervention group, all patients received Module 1, \"Information leaflet,\" and Module 2, \"Structured consultation,\" at various times during treatment. Module 3 “Nutrition counseling” and Module 4 “Relaxation” were given if a patient developed significant nausea, emesis, or weight loss. Patients in the control group received set emesis prophylaxis. Assessments were made on days 1–5 of two chemotherapy cycles and day 8 of the second cycle.

• The study consisted of 208 participants.
• Mean age in the control group was 53.38 years (SD = 13.69 years). Mean age in the intervention group was 50.52 years (SD = 13.21 years).
• In the control group, 48% of the sample was female. In the intervention group, 71.4% of the sample was female.
• Diagnoses were gynecologic (47%), urologic (5%), hematologic (16%), other (32%).
• In the control group, 40% of patients were receiving chemotherapy with level 4 emetogenic potential and 60% were receiving chemotherapy with level 5 emetogenic potential. In the intervention group, 22% were receiving level 4 emetogenic potential and 78% were receiving level 5 emetogenic potential.
• In the control group, 11% of patients were receiving NK1 receptor antagonists (RAs) in addition to 5-HT₃ RAs and steroids. In the intervention group, 20% were receiving NK1 RAs in addition to 5-HT₃ RAs and steroids.

The study was conducted in inpatient and outpatient settings at two German university hospitals.

All patients were in active treatment.

This was a randomized, controlled study.

• All patients were assessed on days 1-5 of two chemotherapy cycles for nausea, vomiting, anorexia, and weight loss using Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).
• A summative score was used to bring each symptom to a 0-10 range; formula: ANE = 2.5 x (anorexia, nausea, vomiting) + 3.33 x weight loss.
• A 100-mm visual analog scale (VAS), ranging from insufficient to very good, was used to capture patient knowledge of chemotherapy-related side effects and effective self-care activities
• The Appraisal of Self-Care Agency (ASA-A) scale was used to assess self-care agency.
• The Self-Care Chemotherapy Side Effect Questionnaire was used to assess self-care activities.
• Quality of life was assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ).

• No significant differences were found between the intervention and control groups in the reduction of ANE or chemotherapy side effect knowledge, self-care activities, or efficacy of competence activities.
• Quality of life (QOL) was significantly better in the control group (p = 0.017).
• Interactions between ANE intensity and the covariates were not statistically significant.
• Nausea (46%) was reported as the most frequent side effect.

The initial hypothesis, that a structured intervention for patients receiving chemotherapy with moderate or high emetogenic potential would significantly decrease ANE intensity, was not supported. The effectiveness of the nursing intervention to reduce chemotherapy-induced ANE and increase QOL could not be supported. Rather, the intervention was reported to have a negative effect on QOL.

• No appropriate control group was included.
• A 16% dropout rate occurred in the intervention group, because of imbalances in randomization (a higher number patients with hematologic cancers with additional radiotherapies).
• No evidence of standardized teaching or written materials was provided.
• A potential for bias existed because the nurses who administered the intervention and assessed the outcomes were aware of group allocation.
• Descriptions of the validity and reliability of the measurement tool were poor.
• The results did not reflect whether the program was effective or if effectiveness was a result of low ANE incidence and intensity.

The SCION program had no effect in reducing distressing ANE.

To evaluate Self Care Improvement through Oncology Nursing (SCION-PAIN), a nursing-administered program to reduce patients’ barriers and improve pain management and pain-related discharge management

The intervention was a nurse-led counseling program to improve pain management and pain-related discharge management by reducing patient-related cognitive barriers. In the intervention group, the SCION-PAIN program was administered by specially trained ward nurses in cooperation with a study nurse. Initial education was standardized, and follow-up was tailored to individual needs. Three initial sessions were provided during hospital stay, and a follow-up telephone counseling session was done two to three days after discharge. Study measures were obtained at baseline, at discharge, and on days 7, 14, and 28 after discharge.

• N = 202  
• AVERAGE AGE = 55.9 years (control); 57.75 years (intervention)
• MALES: 60 (57.1%) control; 59 (57.8%) intervention, FEMALES: 45 (42.9%) control; 43 (42.2%) intervention
• KEY DISEASE CHARACTERISTICS: Gynecologic tumors 21/105 (20%) control and 20/101 (19.8%) intervention; urologic tumors 4/105 (3.8%) control and 12/101 (11.9%) intervention; hematologic malignancies 15/105 (14.3%) control and 1/101 (1%) intervention; gastrointestinal tumors 26/105 (24.8%) control and 40/101 (39.6%) intervention; other tumors 39/105 (37.1%) control and 28/101 (27.7%) intervention

• SITE: Multi-site  
• SETTING TYPE: Multiple settings (inpatient and home setting)
• LOCATION: Eighteen oncology wards from two German university hospitals

• PHASE OF CARE: Active antitumor treatment

Cluster-randomized trial

• The effectiveness of the SCION-PAIN program was assessed by the difference in patient-related barriers to the management of cancer pain between the control and intervention groups using the Barriers Questionnaire II.
• Secondary endpoints were measured with the Brief Pain Inventory (BPI), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ), the German Pain Coping Questionnaire (GPCQ), and the Medication Adherence Scale (MAS).
• Health-related quality of life was measured by the EORTC-QLQ C30.

Compared to usual care, the SCION-PAIN program reduced cognitive barriers in cancer pain management more effectively (p < 0.02), and patients who participated in this program showed a significant increase in perceived knowledge of cancer pain. There was no difference between the groups in average or worst pain intensity. Patients in the intervention group adhered better to pain medications (p = 0.02).

The results of this study demonstrated the effectiveness of the SCION-PAIN program as a brief, easily administered, nurse-led intervention to improve the self-management of pain in patients with cancer. Patient education could help to empower patients to actively participate in their pain treatment and develop self-management skills, improving adherence through care transitions. Participants in the program demonstrated a lower intensity of pain.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Small number of randomized clusters; effects caused by differing personalities of the included participants; the responses to the information provision, different levels of social support, or of mental resilience were not assessed systematically

The results of this study emphasized the integral role of nurses as part of the supportive or palliative care team. This study also confirmed that the inpatient period provides a very valuable and suitable timeframe to improve patients’ self-management and communication skills to prepare them for care transitions.

To evaluate the efficacy of selenium intake for prevention of oral mucositis (OM) in patients with hematologic malignancies who are candidates for allogeneic hematopoietic stem cell transplantation (HSCT) after receiving high-dose chemotherapy (HDC)

Patients randomly were assigned to the selenium or control group in a blocked, randomization schedule. They were given either a selenium tablet (200 mcg) or placebo tablet twice daily, from the starting day of HDC to 14 days after transplantation. Chemotherapy was the same for all patients. All patients received a similar regimen for prevention of mucositis, including nystatin, sucralfate, and mouthwashes with chlorhexidine, plus 10 cc diluted povidone-iodine every three hours. Narcotic analgesics rarely were used to alleviate OM.

• N = 77 patients participated, 74 patients completed, and 3 patients discontinued
• MEAN AGE = 33.3 years
• MEDIAN AGE: 32 years
• RANGE: 18–55 years
• MALES: 56%, FEMALES: 44%
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL)
• OTHER KEY SAMPLE CHARACTERISTICS: Disease status before transplant was evenly matched in the study and control group.

• SITE: Hematology-Oncology and Stem Cell Transplantation Research Center    
• SETTING TYPE: Shariati Hospital  
• LOCATION: Tehran, Iran

• PHASE OF CARE: Treatment
• APPLICATIONS: Adult patients with AML or ALL undergoing allogeneic HSCT

• Double-blind, randomized, controlled study

• Five-grade World Health Organization (WHO) toxicity scale for OM
  • Assessment was carried out by one author under the supervision of the attending physician; both were blinded to patients’ allocation.
  • Assessed on a daily basis (except for weekends and holidays)
  • Assessed from day one of HDC until 21 days after transplantation, or until OM was resolved

The cumulative incidence of OM (WHO scale grades of 1–4) in the selenium group and control group was not significantly different. The incidence of severe OM (grades 3 and 4) was significantly lower in the selenium group (10.8% versus 35.1%, P = 0.013). Two patients in the control group experienced WHO OM grade 4, and none of the patients in the selenium group experienced grade 4. Mean duration of OM was not different between the two groups. Mean duration of OM from the beginning of grade 2, moving up to grade 4, and then returning to grade 2 was significantly lower in the selenium group. No difference was seen in the start day of OM between the two groups.

Selenium supplementation during HDC may prevent severe OM in patients undergoing allogeneic HSCT. Further testing is needed before selenium can be recommended. Further testing is needed to establish optimal dose, time to initiate, and duration of treatment with selenium.

• Small sample: < 100
• Single institution
• No mention of how the outcome assessor was trained to do the assessments
• Authors contradicted themselves when they stated no patients in the selenium group experienced grade 4 OM, yet also stated in the results that mean duration from beginning of grade 2, moving up to grade 4, and returning to grade 2 was significantly lower in the selenium group.

Nurses need to be informed about possible effective methods for reducing and eliminating OM to guide their patients.

Prophylactic laser treatment was administered daily from beginning of conditioning regimen to two days after stem cell transplantation.

Patients received gallium aluminum arsenate diode laser therapy on four anatomic sites of the oral mucosa.

660 nm 10 mW 2.5 J/cm² was administered. Each anatomic site was illuminated for 10 seconds per point.

 

Patients with HSCT from Brazil aged 17-62 years

Historical control group (1999–2000): n = 25

Laser group: n = 24
 

The study occurred from January 2003-September 2004.

WHO

Administration of morphine

Time of parenteral nutrition
 

Incidence of mucositis was the same in both groups.

Percentage of grade 2, 3, and 4 mucositis was less in laser group, not SS (p = 0.12). The laser group took longer to develop grade 1 (4.36 versus 6.12 days [p = 0.01], had fewer days of pain (5.64 versus 2.45 [p = 0.04], and had fewer patients who required morphine (10 versus 4 [p = 0.07].
 

Limited sample size and methodology

Number of patients with grade 3–4 may have been SS with larger sample.
 

 To assess the effect of black cohosh on the frequency and intensity of hot flashes in survivors of breast cancer

The study explored the use of black cohosh for treatment of hot flashes among women with a history of breast cancer. The black cohosh and placebo were supplied by the manufacturer. Each participant received 130 tablets and took one tablet twice daily with meals for 60 days.

• Eighty-five participants were enrolled  (59 on tamoxifen, 26 not on tamoxifen); 42 participants were assigned to treatment; 43 were assigned to placebo; 69 completed all three hot flash diaries.
• Inclusion criteria: Participants had to have completed primary therapy, including chemotherapy and radiation therapy, at least two months before entering the trial.
• Exclusion criteria: Patients could not be using hormonal replacement therapy for hot flashes, be pregnant, have major psychiatric illness, or have recurrent or metastatic breast cancer.
• Participants were stratified based on if they used tamoxifen.

The study was a randomized clinical trial: two-arm randomization, double-blind, placebo-controlled.

Participants were asked to record in a diary the number of hot flashes and the intensity of each. Participants scored severity as 1 = mild, 2 = moderate, and 3 = severe, for three days before starting to take any study pills, then again on days 27 to 30, and on days 57 to 60. FSH and LH levels were measured in a subset of participants at the first and final visits.

Sample size was chosen for 90% power to detect a 30% difference between groups in mean numbers of hot flashes, with a SD of 4.0. All analyses were stratified by tamoxifen use. The primary efficacy end point was mean numbers of hot flashes at 57 to 60 days. The safety end points were changes in mean levels of FSH and LH at the start and end of study participation associated with treatment. In hot flash intensity, both groups experienced a decline during the first month of study participation. The differences between groups in intensity at the end of the study were not significant. For the overall hot flash activity score, the differences between the treatment and placebo groups adjusted for tamoxifen were not statistically significant. Changes in FSH and LH levels of also did not differ between the two groups.

Data provide little evidence of either harm or benefit from using black cohosh to control hot flashes.

A limitation of this study is that participation lasted only two months.

To describe an evidence-based approach to using psychosocial interventions to manage anxiety and depression in adults with cancer

• Initially, authors included 14 systematic reviews and meta-analyses, including randomized and nonrandomized studies of patients with cancer. The final report included 13 studies. Literature was summarized in terms of randomized controlled trials (RCTs) that demonstrated efficacy, in managing anxiety or depression, based on intervention type and patient disease or treatment status.
• Authors presented intervention recommendations with significant (p < 0.05) effects relative to control.
• In addition, authors reviewed National Comprehensive Cancer Care Network (NCCN) Distress Management Guidelines and the clinical practice guidelines of Australia's National Breast Cancer Centre and the National Cancer Control Initiative's Practice Guidelines for the Psychosocial Care of Adults with Cancer (2003).
• The search strategy involved MEDLINE and PsychINFO resources. Authors did not list keywords.
• In addition, authors included existing systematic reviews and meta-analyses of effects of psychosocial interventions on anxiety and depression in adults with cancer and reviews of clinical practice guidelines relevant to distress and psychosocial care of adults with cancer. Exclusion criteria were not listed.

Authors provided examples of psychosocial interventions found to be effective. To be effective, the interventions

• Had to have been superior to a control condition in a published RCT
• Must have demonstrated good potential for dissemination
• Must have addressed common indications for preventing or managing anxiety or depression

Five interventions are illustrated:

• Psychoeducation for new patients with cancer, which resulted in significantly (p < 0.001) fewer symptoms of anxiety and depression as well as greater satisfaction (p < 0.01) with care provided than with usual care
• Patients randomized to problem-solving therapy, which demonstrated significantly (p < 0.05) less depression and maintained results through the one-year follow-up period
• Stress management techniques of paced abdominal breathing, progressive muscle relaxation with guided imagery, and the use of coping self-statements. These techniques yielded significantly less anxiety and depression (p < 0.05) than did usual care.
• Cognitive therapy evaluated against a wait-list control in breast cancer. Women who had clinically significant symptoms of depression demonstrated significantly (p < 0.01) less depression postintervention, with even further reduction occurring during the six-month follow-up period.
• Group cognitive-behavioral therapy for early-stage breast cancer survivors post-treatment, compared with no-intervention controls, indicated that the intervention group reported significantly (p < 0.05) less depression immediately postintervention and at two-year follow-up.

Nine of the 13 publications reached positive conclusions about the efficacy of psychosocial interventions for depression in patients with cancer. Positive supporting evidence recommends behavioral therapy, counseling or psychotherapy, and either of these approaches combined with education, relaxation training for patients not undergoing surgery, and cognitive behavioral therapy. Six of eight publications reached positive conclusions about the efficacy of psychosocial interventions for anxiety. Recommended are behavioral interventions for patients undergoing treatment, relaxation training for patients not undergoing surgery, and cognitive behavioral therapy in the post-treatment period.

In “summarizing the summaries,” limitations included differences in the scope, methods, and manner of summarizing findings and determining recommendations.

Weaknesses found in nearly all the studies included

• Gaps regarding the benefits of psychosocial interventions for diverse demographic, disease, and treatment characteristics. Men and ethnic and racial minorities were underrepresented, and most studies were based on several different types of cancer—usually, early-stage cancer.
• Inconsistency in the evaluation of interventions, number and timing of outcome assessments, and outcome measures used.
• Inadequate reporting of study methodology.
• Lack of research on patients who experience clinically significant anxiety or depression.

Future research should focus on men, minorities, patients with advanced disease, and those who have completed treatment. Studies must include patients who experience significant depression or anxiety prior to intervention. Combinations of interventions should also be studied. Last, timing for screening and intervening is needed as evidence to guide practice.

Databases searched were PsycINFO, MEDLINE, and CINAHL through November 2005.

Seventeen randomized, controlled trials of activity-based interventions were included in the meta-analysis. Activity-based interventions included professionally supervised programs and unsupervised, home-based programs designed to promote exercise activity. To be included, a trial must have included a controlled comparison arm with either a no treatment or placebo condition, must have been a study of an activity-based intervention in adults diagnosed with cancer, one of the study outcomes must have been fatigue or the related constructs of vitality or vigor, and the reported results must have included significant testing of differences between an intervention condition and a control condition.

In all 17 studies in which fatigue, vitality, or vigor was assessed as an outcome, more than three-quarters of the studies measured the construct of fatigue. Fatigue, vitality, or vigor was a primary outcome in slightly more than half of all the studies of activity-based interventions, and it was a secondary outcome in the remainder. Activity-based interventions included professionally supervised programs and unsupervised, home-based programs designed to promote exercise activity. There were numerous differences across these studies in the type of exercise (e.g., aerobic or resistance), mode (e.g., walking or cycle ergometer), and intensity of exercise.

Sixteen of the 17 studies used no intervention control groups or wait-list control groups, and one study used a placebo control condition that involved stretching exercises. Sixty-one percent of the studies provided a home-based exercise intervention and 39% provided supervised exercise programs. No study specified the levels of fatigue, vigor, or vitality used as the eligibility criterion.

• Ten of the 17 trials were in patients with breast cancer only.
• Eleven studies included patients undergoing or about to start chemotherapy and/or radiotherapy, and five included only patients who had completed treatment.
• With regard to disease severity, 10 studies included only patients with nonmetastatic disease, and the remaining studies either did not specify metastatic status or were not restricted in terms of metastatic status.
• The total sample size for each activity-based intervention study ranged from 14 to 155 patients (median = 50 patients).

The effect size for activity-based interventions was not statistically significant (d_w = 0.05; 95% confidence interval [CI] [-0.08, -0.19]), and there were no differences in effect sizes as a function of cancer type (breast cancer:  d_w = 0.12; 95% CI [-0.15, -0.30]) or for all other types (d_w = 0.06; 95% CI [-0.11, -0.24]) or intervention modality (home-based:  d_w = 0.04; 95% CI [-0.13, -0.22]; supervised:  d_w = 0.16; 95% CI [-0.09, -0.41]).

• As with all meta-analyses of exercise that pool results across studies, there was variability in the type, mode, and intensity of exercise, as well as variation in the duration of the intervention and whether the intervention was supervised or home-based.
• Few studies provided an analysis of adherence effects in the intervention group, and no study reviewed by the authors required study participants to have a clinically significant level of fatigue. As a result, the possibility exists that many participants were experiencing little or no fatigue at the time of study entry, thus limiting the ability of these study designs to detect intervention effects.

The current results conflict with the results and conclusions made by other authors who conducted narrative systematic reviews of single studies, with meta-analyses that included both randomized and nonrandomized trials, and with the results of another meta-analysis published more recently. Close comparison of the studies reviewed by the current authors with those reviewed by Cramp and Daniel suggest that the conclusions were different in part because different randomized, controlled trials were examined. Six randomized, controlled trials of activity-based interventions with favorable effects on the outcome of cancer-related fatigue were published after the current authors completed their electronic database searches. In addition, the search strategies used by the current authors excluded two randomized, controlled trials that reported activity interventions (Galantino 2003; Dimeo 2004) that met the criteria for inclusion in their meta-analysis. Moreover, a meta-analysis published in April 2008 by the Cochrane Collaboration that included these more recently published trials together with the two trials that were inadvertently excluded by the current authors concluded that there was a small but statistically significant effect for exercise (standardized mean difference = -0.23; 95% CI [-0.33, -0.13]).

Evaluate the effects of stress management training and exercise, alone or in combination, on well-being, depression, and anxiety among patients during chemotherapy treatment

Patients were stratified by gender, physical activity level, treatment schedule, and whether they also were receiving radiation therapy. They then were randomly assigned to one of four groups: usual care only (UCO), exercise (EX), stress management training (SM), or exercise plus stress management training (SMEX). The SM group met with an interventionist before the first chemotherapy infusion and was provided with a 15-minute video, a booklet, and an audio recording that provided information and instructions for paced breathing, progressive muscle relaxation with guided imagery, and coping statements to manage stress. Patients were instructed on how to learn and use the techniques during chemotherapy. The EX group met with the interventionis before the first infusion and was given a video and booklet providing instructions on use of regular exercise during treatment, with an emphasis on walking. These patients also were provided with pedometers. Patients were advised to exercise for 20–30 minutes three to five times per week and were provided with heart rate targets and shown how to use pulse rate to monitor exercise intensity. The SMEX group was provided with exercise and stress management resources. All patients had the same usual care access to the full range of psychological services provided to all patients and were given information about chemotherapy with written materials. Assessments were done at baseline (T1), six weeks (T2), and 12 weeks (T3). Exercise was self-directed and home-based.

• N = 286  
• MEAN AGE: 57.5 years
• MALES: 34%, FEMALES: 66%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types. The majority were not receiving concomitant radiation therapy.
• OTHER KEY SAMPLE CHARACTERISTICS: More than one-third were college graduates and were married or partnered. All were adults.

• SITE: Single site   
• SETTING TYPE: Home   
• LOCATION: Florida

PHASE OF CARE: Active anti-tumor treatment

• Randomized, controlled trial
• Four groups

• MOS–SF36
• Center for Epidemiological Studies Depression Scale (CESD)
• Beck Anxiety Inventory (BAI)
• Godin Leisure-Time Exercise Questionnaire

The SMEX group had a significant reduction in depressive symptoms compared to the UCO group (p = .048). All groups except for the UCO group showed a decrease in depressive symptoms over time. The effect size was small at its maximum (d = 0.25). BAI scores showed a positive effect in the SMEX group compared to the UCO group (p = .049). In the SMEX group, this decline occurred mainly between baseline and the first follow-up at six weeks, and then anxiety scores increased. The maximum effect size was small (d = .22). No significant differences were seen between the UCO and EX or SM groups in anxiety or depression over time. Exercise and stress management activities increased only in the SMEX group.

The combination of exercise and stress management training reduced anxiety and depressive symptoms during chemotherapy treatment. Exercise alone and stress management training alone did no show positive results. The size of the effect of SMEX was small.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%
• By the first follow-up, about one-third of the patients withdrew. By the investigator's calculations, the study was underpowered.

Findings suggest that the combination of stress management training, using approaches such as progressive muscle relaxation and guided imagery with home-based exercise delivered via video and written guidelines, had a small effect on improving anxiety and depressive symptoms among patients receiving chemotherapy.  This combination was more effective than relaxation training and exercise alone. This suggests that nurses can educate patients to use both of these approaches to manage these symptoms. Effect sizes seen here were small, and the intervention consisted of a single instructional face-to-face meeting and then patient self-directed activity using resources provided. More personal time and follow-up support and encouragement during treatment sessions may increase the magnitude of the effects. Provision of videos and written materials as used here can provide a practical approach to patient education in these areas.