To evaluate the role of auricular acupuncture (AA) in men receiving luteinizing-hormone releasing hormone (LHRH) analogues for prostate cancer on hot flash incidence and severity

The study enrolled 60 consecutive men with prostate cancer who were receiving on LHRH agonist treatment.  Their median age was74 years, and they received weekly AA for 10 weeks.

Patients recorded the frequency of hot flash episodes during the day and at night at 0, 4, and 10 weeks. Participants were asked to grade the intensity of their hot flashes on a 0–6 scale, with 6 representing maximum intensity, and they recorded these data at 0, 4, and 10 weeks.

95% of patients reported a decrease in the severity of symptoms, from a mean of 5.0 to 2.1 (Student’s test, p < 0.01).

Limitations of this study included using a convenience sample and absence of a control group.

To promote self-care by combining informal teaching with group support in a short-term, closed, multiprofessional group

A single group facilitator introduced multiprofessional input from a changing weekly speaker during six 90-minute weekly sessions.

Groups were capped at 12 caregivers and initially focused on patient issues. Transportation for caregivers and a patient-sitting service were provided when necessary.

Four groups were delivered with peer supervision to ensure consistency of the intervention.

The sample (N = 73) was adult, informal, unpaid caregivers of patients receiving palliative care (86% of patients had a cancer diagnosis).

• Home palliative care services
• London, England

A prospective, observational, comparative (no randomization) design was used between those who accepted the intervention (n = 36) and those who declined the intervention but agreed to data collection in the first wave (n = 37), with limitations in group assignment.

• Zarit Burden Inventory
• Palliative Outcome Scale
• Eastern Cooperative Oncology Group Performance Scale
• Coping Responses Inventory
• General Health Questionnaire–12
• State Anxiety Scale

The intervention was not found to affect outcomes for any measures at postintervention (eight weeks) or follow-up (five months).

• The study had no randomization.
• Participants had a choice of comparison group.
• Little information was given about the training or preparation of the group facilitator.
• The sample was mostly Caucasian.
• Attrition was a problem.

A short-term, closed, multiprofessional group aimed to promote self-care by combining informal teaching with group support.

A single group facilitator introduced multiprofessional input from a changing weekly speaker during six, 90-minute weekly sessions. Groups were capped at 12 caregivers.

The group initially focused on patient issues, and transportation for caregivers and a patient-sitting service were provided when necessary.

A total of four groups were delivered with peer supervision to ensure consistency of the intervention.

• N = 73 adult, informal, unpaid caregivers of patients receiving palliative care (86% of patients had a diagnosis of cancer)

• Home palliative care services in London, United Kingdom

The study design was a prospective, observational, comparative (no randomization) between those who accepted the intervention (n = 36) and those who declined the intervention but agreed to data collection in the first wave (n = 37); limitations existed in group assignment.

• Zarit burden inventory
• Palliative outcome scale
• Eastern Cooperative Oncology Group performance scale
• Coping responses inventory
• General health questionnaire-12
• State anxiety scale

The intervention was not found to affect outcomes for any measures at post-intervention (eight weeks) or follow-up (five months).

• The study had no randomization.
• Participants had a choice of comparison group.
• Little information was given about the training or preparation of the group facilitator.
• The sample was mostly Caucasian.
• Attrition was a problem.

To update and evaluate intervention studies and current state of the science regarding support for caregivers in a systematic review

• Databases used in the search were MEDLINE, CINAHL, and PsycINFO.
• Key words were carer; caregiver; cancer; palliative; end of life; and terminal.
• To be included in the review, studies had to involve adult caregivers/adult recipients, be English language, occur in the cancer palliative care setting, and be intervention-based (from 2001 to July 2010).
• Articles reporting case studies, interventions without evaluation data, and interventions during the bereavement phase, as well as articles included in Harding and Higginson's 2003 systematic review paper, were excluded.

• The search revealed a total of 10,817 references.
• Studies were evaluated using the Jadad Rating Scale and the Quality Rating Scale.
• Despite the exclusion of bereavement studies, multiple studies are included in table and summarized.
• An international sample of studies was represented.
• Despite intent to focus on cancer populations, nine studies were in palliative care (not clearly cancer); a few studies were based on program implementation (process), so no specific caregiver outcomes were reported.

• A total number of 33 studies were included in the review. 
• Sample range of subjects across studies was 2–2,000+ (less than 25 [n = 10]; 25–100 [n = 10]; more than 100 [n = 13]).
• Interventions were dyad (n = 16) or caregiver only (n = 17).

• End-of-life phase
• Palliative care

Group interventions were studied most often, although only two of the studies included reported a statistically significant benefit compared to controls. The next largest group of studies investigated one-on-one psychological interventions. Two of these showed a positive effect for patient/carer dyads. Overall findings were equivocal, with about the same number of studies showing significant improvement with the intervention as those showing no change or difference between groups. The nature and timing of interventions varied greatly across studies included.

The authors identified seven categories of interventions: (a) one-on-one psychological, (b) dyad psychological, (c) palliative care/hospice (delivery), (d) informational/training, (e) respite, (f) group intervention, and (g) physical.

Given the limitations, differences in the nature of interventions reviewed, and inconsistencies of findings across studies, this review does not provide strong support for any particular type of intervention.

This summary has limited guidance due to lack of synthesis to actually guide practice. There were also inconsistencies between the inclusion and exclusion criteria and the studies reported; not all have clear implications to cancer, affect active information caregivers, or measure caregiver outcomes.

MEDLINE, CancerLit, PsycInfo, and CINAHL databases using the search terms carer(s), caregiver(s), palliative, and cancer were used.

Twenty-two articles reported interventions for adults actively providing informal care to noninstitutionalized patients with cancer and patients receiving palliative care. Only six of the interventions had been evaluated: Two used a randomized, controlled trial design, three used single group design (two prospective, one retrospective), and one was evaluated by facilitator feedback.

The sample was comprised of caregivers from palliative or cancer care populations.

Problem-solving and education interventions led to overall improved caregiver burden, although the improvement was not significant; however, significant improvements were seen in a subsample of burdened caregivers (at baseline). Home nursing and respite care services improved caregiver satisfaction, quality of life, physical and emotional stress or distress, pain, health, and sleep in a few studies. Problem solving and education are likely to be effective in reducing caregiver burden.

• Too few studies evaluated interventions for caregivers.
• Most studies were of descriptive or cross-sectional design.
• Outcome measures within studies varied widely.
• Only two studies measured caregiver burden or strain as an outcome.

To evaluate the safety and efficacy of macrogol 3350 plus electrolytes in the treatment of chronic constipation in children.

All children received macrogol 3350 plus electrolytes for 12 weeks. Children aged 2 to 6 years received one sachet daily on days 1 and 2, one sachet twice daily on days 3 and 4, and one sachet three times daily on day 5. Children aged 7 to 11 years received one sachet twice daily on days 1 and 2, and two sachets twice daily on days 3, 4, and 5. After day 5 and until the end of the study, the dosage was titrated according to fecal form. The dose was increased by one sachet per day in the event of continued hard stools or no bowel movement, and decreased by one to two sachets per day in the event of loose stools or diarrhea.

The mean duration of treatment was 75.5 days, during which time the participants took an average of 1.3 sachets (6.9 g) of macrogol plus electrolytes per day.

• The study reported on a sample of 78 children with chronic constipation for greater than three months.
• Patients were aged 2 to 11 years, with a mean age of 4.9 years (SD = 2.6).
• The sample comprised 34 boys (44%).
• Patients were included in the study if they had chronic constipation defined as fewer than three complete bowel movements per week over the previous 14 days, in association with either straining or passage of hard stools in at least 25% of bowel movements. The existing constipation was either untreated or inadequately treated by laxatives.
• Patients were excluded if they were treated for fecal impaction with bowel washouts within the previous two months or if they had a past history of intestinal perforation or obstruction; Hirschsprung disease; paralytic ileus; toxic megacolon; severe inflammation of the intestinal tract; urinary tract infections; uncontrolled renal, hepatic, or cardiac diseases; endocrine disorders; or any other severe unstable coexisting disease within the previous 30 days.

Royal Children’s Hospital, Melbourne, Australia

This was an open-label, nonrandomized study.

• The primary outcome was number of spontaneous defecations per week.
• The secondary outcomes were fecal form, abdominal pain, rectal bleeding, pain on defecation, straining, soiling, amount of stool, stool withholding, and assessments of efficacy by the investigators and parents.
• Safety assessments included adverse events, laboratory tests (full blood examination; urea, electrolyte, and liver function tests) and changes in vital signs. Adverse events were monitored throughout the study; venous blood samples for laboratory safety were taken at visits 1, 3, and 5. 
• Compliance was rated on a four-point scale from very poor (less than 25% of prescribed dose taken) to very good (more than 75% of prescribed dose taken).

•  Sixty-five patients (80%) completed the study.
• The mean number of spontaneous defecations per week increased from 1.4 (SD = 0.55) at baseline to 6.8 (SD = 3.45) after 14 days and 7.1 (SD = 3.45) at 12 weeks (p < 0.001).
• Stool frequency remained unchanged from visit 2 until the final visit (ANOVA: F = 0.81, p = 0.518).
• Similar improvements were found in the secondary efficacy variables. A significant reduction in reported abdominal pain from 53 children (68%) at baseline to 3 (4%) at the final visit occurred (p < 0.0001). Similarly, 61 children (78%) had pain on defecation at baseline, compared with 7 (9%) at the final visit (p < 0.0001). Treatment was well tolerated.
• Of 318 adverse events, 262 (82%) were considered mild, and 241 (76%) were deemed unrelated to treatment.
• Only 3 children (4%) were withdrawn because of poor compliance. Mean duration of treatment was 75.5 days, during which time the participants took an average of 1.3 sachets (6.9 g) of macrogol plus electrolytes per day. Ratings of excellent compliance (higher than 75% intake of study medication) were reported for 86%, 81%, 76%, and 79% of participants at visits 2, 3, 4 and 5, respectively.

Longitudinal studies are needed to determine the long-term outcome of successful treatment of chronic constipation during childhood.

• The study did not mention which electrolytes were added and in what amount.
• This study design did not allow determination of a true treatment effect from spontaneous improvement.
• Open-label studies are subject to bias in assessments of efficacy, but the findings in this study are supported by results from several nonrandomized and randomized controlled studies of polyethylene glycol 3350–based preparations in children.
• Study results are not relevant to oncology.

STUDY PURPOSE: To examine physical and psychological benefits of yoga interventions in women with breast cancer

TYPE OF STUDY:  Systematic Review

DATABASES USED: MEDLINE, PsychINFO, the Cochrane Library, Embase, CINAHL, AMED, Web of Science, and Scopus

KEYWORDS: Yoga, breast cancer, and breast neoplasm

INCLUSION CRITERIA: Yoga intervention; women with breast cancer; a randomized controlled trial design (RCT); the studies were original full reports; and the studies were published in peer-reviewed journals.

EXCLUSION CRITERIA: Studies that investigated complementary and alternative medicines or exercise interventions; conference abstracts

TOTAL REFERENCES RETRIEVED: Eighteen RCTs met the inclusion criteria out of 274 initial data. The 274 initial articles returned were reduced to 132 after duplicates were removed. Further reductions occurred due to multiple publications of the same data or the same outcome measures; same studies or continuation of same studies also were removed from review.

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Physiotherapy Evidence Database (PEDro Scale) was used to rate methodological quality of RCTs. It is a 10-item scoring system that evaluates internal validity (random allocation; concealment of allocation; similarity of groups at baseline; blinding of participants, therapists, and assessors; adequate follow-up and undertaking an intention-to-treat analysis) and statistical information. A total score below 4 was considered to be of “poor” methodological quality; between 4 and 5 was considered to be of “fair” quality; 6 to 8 was considered to be of “good” quality; and 9 or 10 was considered to be of “excellent” quality. Two reviewers independently rated each study.

• FINAL NUMBER STUDIES INCLUDED: N = 18
• SAMPLE RANGE ACROSS STUDIES: The sample size range was 18–164 at baseline to 14–75 at follow-up.
• TOTAL PATIENTS INCLUDED IN REVIEW: N = 760
• KEY SAMPLE CHARACTERISTICS: The mean age (based on 10 studies adequately reporting age) was 52.7 years (mean age range = 45–62.9 years). Most studies investigated women with early or advanced stage disease; three included women with noninvasive breast cancers. Seventeen studies conducted repeated measures at a minimum of two time points (pre- and post-intervention) using an adequate baseline assessment performed before or after randomization (though not all studies reported change scores). Follow-up occurred over a range of one to six months.

PHASE OF CARE: Active antitumor treatment and transition phase after active treatment. Twelve studies were conducted during treatment; six were conducted post-treatment (two months to six years); two were conducted during mixed time periods during and after treatment (mean time since diagnosis or treatment = 1.7–6.5 years).     

APPLICATIONS: Elder care and palliative care

• The most common intervention was integrated yoga (consisting of postures, breathing, and meditation) and Iyengar and Hatha yoga (71 %) given via self-practice (83%) or in-class lessons. The duration was 4 to 12 weeks (median 8 weeks).
• The primary outcome variables of the yoga intervention were (1) mood and psychosocial functioning (depression, anxiety, stress, and psychological symptom distress); (2) health-related quality of life; (3) fatigue; and (4) biological changes and physical measures (i.e., wound healing, hospital stay, TNF-alpha, immunoglobulin, nausea and vomiting, and overweight).
• Overall, all 18 studies in the review reported positive effects from the yoga interventions, with the greatest impact on global QOL scores and emotional well-being. Few in the yoga program experienced improved cancer-related fatigue. Biological measures varied, and conclusions for this outcome cannot be drawn.
• Total quality rating scores for the RCTs was a median of 6, indicating that overall the quality was “good” (range 1 to 8); one study was rated methodologically poor (score 1). Low quality was found in the description of the randomization process (i.e., concealed allocation), blinding (i.e., blinding of assessors), and reporting of adequate follow-up (i.e., > 85% of subjects).
• Adherence was a major problem of the intervention.

• Qualities measures were used to evaluate studies. Overall study quality appears to be good, and the studies relatively consistently reported that yoga may be a useful practice.  
• However, long-term and specific objective effects of yoga interventions need to be further examined. Outcome variables in this review varied across studies. Only seven studies used validated depression measures, and only two studies used a validated anxiety measure. Among them, six studies reported positive effects from the intervention on depression and/or anxiety, whereas two studies reported no effect.
• The intervention program ranged from 6 to 26 weeks with up to three sessions of yoga per week and were generally well received and safe. Yet, more safety data are required to report that yoga is not harmful and is a credible intervention compared to conventional therapies. More economical and practical information also is needed to implement yoga.

This review does not specifically focus on depression and anxiety. Only studies with patients with breast cancer were included for this review. Thus, only several studies with depression or anxiety as outcome variables were included in the final review. None of the studies were found to have excellent design (e.g., small sample size and lack of long-term follow-up).

The intervention may be beneficial, yet its specific effect on depression and anxiety should be further examined. Also, the intense, duration, and practical issues (e.g., who provided the intervention, who paid the cost) should be considered. Nurses can conduct large-sample, long-term studies of the efficacy of yoga using instruments that measure change scores and calculating sufficient power to detect group differences.

To evaluate effects of an elemental diet for prevention of radiotherapy or chemotherapy-induced oral mucositis in patients with oral cancer

Data were collected from medical record review.  All patients received 2 Gy per day, fives days per week to the oral cavity for a total dose of 60-70 Gy with or without concurrent chemotherapy. 80 g of elemental diet powder was dissolved in 300 ml of water for patients to swish around in the mouth and swallow once daily. All patients were to follow a similar regimen of oral brushing, gargling with 4% azulene sodium sulfonate and water, lidocaine gargle, NSAIDs, and/or opioids as needed for pain. Data were compared between those who had received the elemental diet versus individuals who had not.

• N: 74
• AGE: Mean = 64.9, range = 30-91
• MALES: 67.6%        
• FEMALES: 32.4%
• KEY DISEASE CHARACTERISTICS: Squamous cell cancer – most located on the tongue or gingiva.  All were stage III or IV

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

• Retrospective Two group cohort comparison

• CTCAE version 4

Mulivariate analysis showed that use of the elemental diet (p = 0.004) and no concurrent chemotherapy (p = 0.004) were significant factors to predict the grade of mucositis observed. For those getting RT only, the incidence of grade 3 or 4 mucositis was lower in the group who had the elemental diet, but the difference was not statistically significant. For those getting both chemotherapy and radiation therapy (n = 49 patients), rates of more severe mucositis were 79.2% among controls and 40% in the elemental diet group (p = 0.005).

Having patients swish and swallow an elemental diet preparation appeared to reduce the severity of oral mucositis in patients with oral cancer getting combined radiation and chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Administration of an elemental diet preparation as used here might have a protective effect to reduce severity of oral mucositis in patients with oral cancer getting combined radiation and chemotherapy. This is a low-risk type of intervention that warrants further investigation. Prospective, well-designed trials are needed to establish efficacy.

To compare the effects of immediate-release morphine to those of flurbiprofen axetil in the treatment of cancer-related breakthrough pain

For the treatment of cancer-related breakthrough pain, patients in the flurbiprofen group received 50–100 mg flurbiprofen axetil IV and patients in the control group received a proportional dose of immediate-release morphine. Incidents of breakthrough pain were assessed for three days.

• The sample was composed of 217 patients.
• Mean patient age was 49.7 years.
• Of all patients, 60% were male and 40% were female.
• Cancer types in the sample included lung, prostate, breast, liver, esophagus, and pancreas cancers. All patients had severe pain that they rated at 7 or higher on a visual analog scale. Patients' background pain was controlled, and all patients experienced multiple instances of breakthrough pain.

• Single site
• Inpatient
• China

Two-group observational study

• Visual analog scale (VAS)
• Number of breakthrough episodes
• Time to relief of breakthrough pain
• World Health Organization criteria for adverse events

Average time to meaningful pain relief following administration of the rescue medication was 16 minutes in the flurbiprofen group and 27.3 minutes in the morphine group (p < 0.01). Patients in the flurbiprofen group and the morphine group received significant reduction in pain, from an average of 7 to 2.2 or 3.0, respectively, on the VAS. The number of breakthrough episodes was significantly lower in the fluribprofen group than in the morphine group (p = 0.000). Most patients needed 50 mg flurbiprofen; only five patients required a dose increase. No serious complications were observed. The prevalence of side effects was similar in both groups

IV flurbiprofen may be an effective intervention for cancer-related breakthrough pain.

• The study had risks of bias due to no blinding and no randomization and as a result of sample characteristics.
• Authors did not specify unintended interventions or other interventions that would influence results. 
• Measurement tools and methods were not well described.
• The study does not state clearly if patients were assigned to study groups or if assignment was random. The timing of pain assessments is unclear. Authors provide no information about background analgesics or duration of pain.
• Authors defined adequate pain control at baseline as pain with a VAS rating of 7 or higher. Whether this is actually adequate control is questionable. In addition, the study does not specify whether the VAS rating referred to worst pain or usual pain.

Flurbiprofen appears to be a promising agent for the management of cancer-related breakthrough pain. This study has several limitations. Further research regarding flurbiprofen is warranted.

To evaluate the effects of a rehabilitation program on quality of life (QOL), fatigue, fear of movement (kinesiophobia), distress, anxiety, depression, and physical condition.

The intervention consisted of a 12-week comprehensive rehabilitation program based on Herstel and Balans’s 12-week program. The program combined physical exercise, psychoeducation, and individual counseling. Each component consisted of 

• Physical training to enhance cardiorespiratory and muscular capacity. Physical training occurred three times a week for 60 minutes and was led by an expert physiotherapist.
• Psychoeducation to enhance self-confidence, autonomy, and coping skills. Psychoeducation occurred eight times. Each session lasted 90 minutes.
• Individual counseling to improve patients' follow-up and provide an individualized program. Individual counseling consisted of a 10-minute session at the start of the program, at the beginning of every exercise session, and at the end of the program.

The intervention was provided at no cost to patients.

• The sample was comprised of 36 patients (83% female, 17% male).  
• Mean age was 50 years (standard deviation [SD] = 12 years; range 28–75 years).
• The majority of patients (n = 27) had breast cancer.
• Patients had completed all cancer treatments, except long-term hormone treatment. Patients had received diverse treatments (i.e., chemotherapy, radiotherapy, surgery, and biotherapy) before the intervention.
• Time lapse since the last treatment varied, with a mean of nine months (SD = 14 months; range 0–60 months).
• Twenty patients were on hormone treatment during the intervention.

• Single site
• Outpatient
• University hospital in Belgium

• Patients were undergoing the transition after initial treatment phase of care.
• The study has clinical applicability for late effects and survivorship.

The study used a prospective, one-group pre-/posttest design.

• European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), to measure global QOL and physical functioning and condition
• Functional Assessment of Cancer Therapy–Fatigue (FACT-F), to measure fatigue
• Hospital Anxiety and Depression Scale (HADS), to measure depression and anxiety
• RAND 36-Item Health Survey (RAND-36), to measure general health-related QOL
• Tampa Scale of Kinesiophobia, to measure fear of movement or injury
• Distress Barometer, to measure distress
• Tecumseh Step Test, to measure cardiorespiratory fitness

• The authors noted significant improvements in QOL (p < 0.001), physical condition (p = 0.007), fatigue (p = 0.01), and depression (p = 0.012).
• Kinesiophobia (p = 0.229), distress (p = 0.344), and anxiety (p = 0.101) did not change significantly.
• In regard to depression, HADS scores changed from 5.71 (SD = 4.7) to 4.13 (SD = 4.36). This change was statistically significant.

The rehabilitation program was associated with a positive effect on depression, fatigue, and QOL; however, weaknesses in study design may preclude making a definitive conclusion based on the study. Prospective randomized studies must determine the long-term impact and the relative contribution of the program versus spontaneous recovery. Future research should also consider the cost-effectiveness of the rehabilitation program.

• The small sample size and nature of the sample (i.e., patients with early stage breast cancer) threaten the external validity of the study.
• The study did not include an appropriate control group. The lack of control group threatens the internal validity of the study. Thus, statistically significant effects may be placebo effects or time effects.
• The study did not include information regarding the scale and range of scores and method of score computation; therefore, the credibility of analysis based on the scores is unknown.
• The authors did not report whether patients were clinically depressed and if the improvement in the depression score indicates a clinically significant change.
• For various reasons, more than half (51%) of the patients who had an intake interview did not participate in the study. This may generate problems associated with the applicability of the program to patients with cancer.

Multidisciplinary rehabilitation can be one way to manage depression and fatigue in patients with cancer.