To investigate the effect of 3M™ Cavilon™ No-Sting Barrier Film and topical corticosteroids on irradiated skin

Thirty-nine post-operative patients with breast cancer were assigned to the three intervention groups using simple randomization. The three treatment groups included 3M barrier film versus no treatment [n = 13], Elomet^® (mometasone furoate [corticosteroid] cream) versus no treatment [n = 9], and Elomet versus 3M barrier film [n = 17]. Each participant’s treatment field was divided in half so that she received both radiodermatitis treatments assigned to the group. Elomet and 3M film barrier were applied every other day, excluding weekends, by the same staff, and the reactions were observed. For patients with more advanced disease, chest wall recurrence, or lymph node involvement, those areas also were irradiated. The skin reactions in the neck and supraclavicular areas were not included in the study. The primary end points were time to onset of grade 1 pruritus, a pain score of 3, and presence of grade 2 dermatitis. The secondary end points were grade 3 radiodermatitis and pain scores by each treatment.

• N = 39  
• AGE = 30–76 years
• MEAN AGE = 51 years
• MALES: 0%, FEMALES: 39%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chest wall, remaining breast after conservative surgery, treated skin, untreated skin, post-operative

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

• PHASE OF CARE: Active antitumor treatment

Open-label clinical trial of barrier film or corticosteroid cream, versus no treatment to prevent/reduce grade 1 pruritus, grade 2–3 radiodermatitis, and pain score of 3.

• Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 for dermatitis associated with radiation and for pruritus
• A pain score was collected.
• SPSS software version 10 was used to analyze the data.

The authors recommend using the barrier film starting at the commencement of treatment to reduce friction and irritation, particularly in skin folds and the axilla. However, study findings here do not show an effect on development of radiodermatitis. Once pain and hyperemia occur, the barrier film is discontinued and corticosteroid cream started. The effectiveness of corticosteroid on prevention of radiodermatitis should be investigated further under a lager randomized study.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs
• Other limitations/explanation:  The researchers said they used “simple randomization” to assign the participants to the three treatment groups. They did not explain what they meant by “simple randomization.” The number of participants in each treatment group differed. Demographics for the members of each treatment arm were not provided. Some participants were receiving first-line treatment for a new breast cancer. Others were experiencing a recurrence. Some participants had a modified radical mastectomy, and some had breast-conserving surgery. The authors did not report the use of a power analysis to determine the sample size required to accurately identify statistically significant differences between the treatments, nor the expected effect size of the intervention. It is unlikely that 13 participants in each treatment arm would provide enough power to detect significant differences. The participants in the 3M barrier film versus no treatment and the Elomet (mometasone furoate [steroid] cream) versus no treatment arms served as their own control. The participants in the Elomet versus 3M barrier film arm did not have a control. The volume and type of tissue in each half of the treatment field may not have been identical. The skin dose in each half may have differed and was not reported in this article. Inter-rater reliability was not reported. The method of measuring pain score was not reported.  A pain score of 3 was an endpoint, but the range was not identified.

The effectiveness of corticosteroids on prevention of radiodermatitis should be investigated further in a large, randomized, controlled clinical trial with adequate power to detect clinically significant differences and controlling for confounding factors.

To evaluate whether using dietary interventions could be beneficial in the treament of arm lymphedema in patients who have breast cancer-related lymphedema

• The study sample (N =64) was comprised of female patients.
• Patients were stratified by volume and treatment and then randomized to one of three groups.
  • Weight reduction with decreased calories to 1,000–1,200 a day
  • Low-fat diet without change in calories, reducing dietary fat to 20% of total calories
  • Control group without change from intake
• Fifty-one patients completed the study.

The study used a randomized controlled trial design with two interventions and one control group.

• The volume measurements were performed by lymphedema practitioners who were blinded to the intervention using a Perometer and a volume equation using circumference.
• Arm circumference was measured every 4 cm.
• Height and weight were measured.
• Skin fold thickness was measured at four sites.

Results showed significant reduction in body weight (p = 0.006), body mass index (p = 0.008), and skin fold thickness measured at four sites (p = 0.044) in the weight-reduction and low-fat groups but not in the control group. There was a reduction in excessive arm volume over the 24 weeks but no significant difference between groups. There was a significant correlation between weight loss and a reduction in excess am volume irrespective of the dietary group (p < 0.002). Weight loss for the control, weight-reduction, and low-fat groups were 60%, 95%, and 76%, respectively. Weight reduction appears to be an effective means of assisting in the reduction of arm volume during the treatment of the lymphedema arm.

A good study that identifies an important risk factor and intervention.

• The study was ambitious and could have benefited from a simple weight-controlled study.
• Patients used compression sleeves and bandages during the intervention; nevertheless, the patients were distributed throughout the groups.
• Patients had poor adherence to diets.
• Some patients who were instructed not to lose weight did.
• The calorie intake of 1,000–1,200 per day is low for anyone.

Participants initially were given donepezil 5 mg per day. After 6 weeks, dosage was increased to 10 mg per day for a total of 18 weeks. Treatment then was discontinued for a six-week washout period. Patients, therefore, served as their own control at two points (baseline and post-washout). After week 30, patients were given the choice to continue using donepezil at 10 mg per day. Patient outcomes were assessed at baseline and at week 6, 12, 24, and 30 (following the washout period).

• N = 35 enrolled (24 patients remained on the study and completed all assessments)
• MEDIAN AGE = 45 years
• KEY DISEASE CHARACTERISTICS: All had primary brain tumor, mostly low-grade glioma
• FEMALES: 46%
• OTHER KEY SAMPLE CHARACTERISTICS: 92% white, 8% black. Patients who remained on the study did not differ significantly at baseline from the patients who dropped out on the measures of sex, race, mood, and cancer-related quality of life. Patients remaining on the study were significantly younger than those who dropped out.
• EXCLUSION CRITERIA: Less than 18 years of age, life expectancy of less than 30 weeks, received partial or whole brain radiation less than six months before enrollment, imaging evidence of tumor progression in the previous three months, brain tumor treatment planned during course of study

• Wake Forest University School of Medicine in Winston-Salem, NC

• Active treatment

• Open-label, phase II clinical trial

• Profile of Mood States (POMS)

The donepezil intervention group demonstrated a significant improvement in fatigue from baseline to 24 months as shown by the POMS subscale for fatigue (p = 0.03).

• Lack of a neutral comparison group
• Possible that observed improvement is result of “practice effect,” as participants were required to fill out forms four times over a 7.5-month time period

The study was conducted to determine whether donepezil improved cognitive functioning, mood, and quality of life in patients who had irradiated brain tumors.

All participants received 5 mg/day of donepezil for 6 weeks, then 10 mg/day of donepezil for 18 weeks, followed by a washout period of 6 weeks where no treatment was administered. 

• The total number of enrolled participants was 35, with 24 completing all outcome assessments.
• The participants were 54% male and 46% female.
• The participants were 92% Caucasian and 8% black.
• 23 participants had glioma (about half low-grade), 4 participants had meningioma, 7 patients had other primary brain tumors, and 1 patient had metastatic disease).

This was a prospective, open-label, phase II study.

• Mini-Mental State Examination (MMSE) for global cognitive functioning
• Trail Making Test Parts A and B (TMT-A and TMT-B) for visual attention, motor speed, and cognitive flexibility
• Digit Span Test for attention and concentration
• Revised Rey-Osterrieth Complex Figure Test for visual construction skills and figural memory
• Controlled Oral Word Association Test for verbal fluency
• California Verbal Learning Test-II for verbal memory
• Health-Related Quality of Life (HRQOL) measures for health-related quality of life
• Karnofsky Performance Status Scale (KPS) for general well-being; scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease)
• Functional Assessment of Cancer Therapy-Brain (FACT-Br) for cancer-related quality of life for patients with brain tumors
• Profile of Mood States assessment for subscales in depression, anxiety, anger, subjective confusion, fatigue, and vigor, as well as an overall mood score for distress

Significant improvement was noted between the pre-treatment baseline  and week 24 on measures of attention/concentration, verbal memory, figural memory, and a trend for verbal fluency (all p < 0.05). Confused mood was also improved from baseline to 24 weeks (p = 0.03). Health-related quality of life improved from baseline to 24 weeks in brain-specific concerns (p = 0.003), emotional functioning (p = 0.04), and social functioning (p = 0.02), with a trend for improvement in total health-related quality of life (p = 0.07).

Ten of 21 participants, or 48% of those who completed the study through the 30-week assessment, chose to go back on donepezil. A total of 63 toxicities ranging from grade 1 to grade 3 were reported.

Mood, health-related quality of life, and cognitive functioning (attention/concentration, verbal memory, and figural memory) were significantly improved following a 24-week course of donepezil.

• The study had a small sample size.
• The study had no control group for comparison. 
• Participants who completed the entire study differed significantly from those who dropped out in terms of age (p = 0.04). No control comparison.
• The repeated measures study did not address practice effects.
• Other co-occurring events may explain improvements in cognitive functioning. These events include concurrent tumor shrinkage, resolution of radiation-induced fatigue, and repair and recovery from radiation-induced brain damage.

To assess the effectiveness of an intervention using structured telephone interventions for the caregivers of patients diagnosed with gastrointestinal cancer that had a poor prognosis to improve psychosocial outcomes of the patient and caregiver

This intervention was a randomized, controlled trial in which caregivers were assigned to either the family connect (FC) telephone intervention or usual care. The FC group received four standardized telephone calls in the 10 weeks after patient hospital discharge. The caregivers’ quality of life, caregiver burden, unmet supportive needs, and distress were assessed at three and six months.

• N = 128 pairs  
• AVERAGE AGE = 55.7 years (intervention); 52.7 years (control)
• MALES: 61%, FEMALES: 39%
• KEY DISEASE CHARACTERISTICS: Patients with all cancers found within area of the gastrointestinal system and their caregivers were included.
• OTHER KEY SAMPLE CHARACTERISTICS: Most were English-speaking, and all received some prior form of cancer treatment.

• SITE: Four metropolitan hospitals in Sydney, Australia
• SETTING TYPE: Initial, hospital, follow up, telephone
• LOCATION: Sydney, Australia

• PHASE OF CARE: Newly diagnosed or recurrent primary upper gastrointestinal cancer, metastatic liver disease, or stage 4 colorectal cancer
• APPLICATIONS: Palliative care 

This study was a parallel-randomized trial with a 1:1 group allocation.

• Quality of Life (QOL) scale Short Form 12 (SF-12) v2
• Caregiver Reaction Assessment (CRA)
• Functional Assessment of Cancer Therapy–General (FACT-G)
• Supportive Care Needs Survey (SCNS-34) patient version
• Single-item distress thermometer

Caregiver QOL scores were similar in both groups. The group that was randomized to receive the intervention reported a greater sense of social support and reduced worry about finances, and they also had fewer rehospitalization and emergency department visits.

This intervention did not demonstrate significant improvements in quality of life or sense of well-being for the caregivers. There were some trends observed through data analysis, which warranted the continued development of meaningful, telephone-based, caregiver-focused supportive care interventions.

• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Other limitations/explanation: The high level of withdrawals prior to randomization (20% of caregivers and 32% of patients) may have resulted from need for both patients and caregivers to agree to participate in the study.

This study did demonstrate the potential to improve patient and caregiver QOL. Future nursing research should focus on continuing to educate caregivers with strategies to identify and address patient care needs, which can ultimately reduce the overall cost to healthcare systems.

To compare the psychosocial outcomes of two different approaches for management of women undergoing colposcopy: immediate large loop excision versus punch biopsies with recall

In a larger study, women had been randomly assigned to cytological surveillance or colposcopy for low-grade abnormal cervical cytology. Women having colposcopy then were randomly assigned to either immediate large loop excision or to a group having punch biopsies and selective recall. Assessments were done at baseline, at six weeks post-procedure, and at 12,18, 24, and 30 months.

• N (sample size) = 966 completed six-week assessments, and 594 completed 30-month assessments.
• AGE: Mean and range were not provided. All patients were younger than 60 years; 71.6% were younger than 40 years.
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: 37.6% were high risk based on initial cytology.
• OTHER KEY SAMPLE CHARACTERISTICS: 76.6% were employed full- or part-time.

• SITE: Mutli-site   
• SETTING TYPE: Outpatient
• LOCATION: United Kingdom

PHASE OF CARE: Diagnostic

Randomized controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Profile of Mood States (POMS) 
• Spielberger State Trait Anxiety Inventory

There were no differences between groups in prevalence of significant depression at any study time-point. In all patients, the median POMS score fell significantly from recruitment to 12 months (p < .001) and remained stable thereafter. There were no significant differences in average scores at any time-point. In all patients, anxiety fell significantly from baseline to six weeks post-procedure (p < .001) and remained stable thereafter. There were no significant differences between groups at any time point in the study.

There were no differences in symptoms of anxiety and depression based on the type of management examined here for women undergoing colposcopy. In all patients, anxiety and depression declined significantly shortly after the procedure and then remained stable over the next 24 months. However, the prevalence of significant depression (HADS depression subscale ≥ 8 ) increased from 6% precolcoscopy to 9.6% at 30 months.

• No subgroup analysis was performed based upon whether or not patient had clinically relevant anxiety or depression at baseline.
• No information is provided regarding use of medications or any other interventions aimed at these symptoms.
• The study fails to take into consideration the many variables that can impact changes in anxiety and depression symptoms over time.

Findings suggest that the specific approach to management with colposcopy does not significantly impact anxiety and depression in women with low-risk abnormal cervical cytology. The timing of depression increase seen here might suggest that extended follow-up after colposcopy and treatment may be associated with depression for some women. Which of the strategies examined here offers the best balance between benefits and harms is a matter of continuing debate.

To assess the impact of an eight-week mindfulness-based cognitive therapy program on individuals experiencing distress as a consequence of cancer 

Participants included people with a history of cancer and those the study defined as carers. Participants were people who called the Cancer Council South Australia Helpline. They were assessed for anxiety and depression before and after a course of mindfulness-based cognitive therapy (MBCT). The MBCT program consisted of eight weekly two-hour sessions facilitated by an experienced counselor. The program sessions included these topics: stepping out of automatic pilot; dealing with barriers; mindfulness of one’s breath; staying present; acceptance; holding, allowing, letting be; thoughts are not facts; how to best take care of oneself; and using learned skills to control future mood. An optional three-hour follow-up session occurred six weeks after program completion, to reinforce mindfulness principles.

• The sample (N = 21) included 16 cancer survivors and five carers.
• Mean participant age was 52 years, with a range of 34–69 years.
• The sample was 14% male and 86% female.
• The largest number of participants had breast cancer; glioblastoma multiforme, adenoid cystic carcinoma, acute myeloid leukemia, lymphoma, liver cancer, bladder cancer, ovarian cancer, and prostate cancer were represented.
• Time since diagnosis was 3–120 months.

• Single site  
• Adelaide, South Australia, Australia

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

Prospective, one-group, pre/post-test design

• Beck Depression Inventory (BDI)    
• State-Trait Anxiety Inventory (STAI)
• Freiburg Mindfulness Inventory (FMI)

• Mean depression scores decreased from mild (mean: 15.0; SD = 9.07) to minimal (mean: 10.37; SD = 5.92) and for anxiety levels from clinical (mean: 43.17; SD = 13.25) to nonclinical (mean, 31.39; SD = 9.61). 
• At the three-month follow-up, depression levels remained roughly the same as they had been at baseline. Compared to pretreatment levels of mean anxiety, at three months researchers noted a slight but nonsignificant increase.
• Mindfulness level at each time point had significant negative correlations with depression and anxiety.

Poor study design and small sample prevent drawing a valid conclustion about the effect of the intervention.

• The study had a small sample size (particularly in regard to carers), with fewer than 30 participants. This fact limits generalizability.
• The study did not include an appropriate control group.
• The authors' recruitment method, using those who had called a helpline as the recruitment pool, was unusual. 
• Defining and measuring the concept of mindfulness is difficult.
• Measurement and intervention time points, in relation to cancer treatments, were unjustified; thus, the findings may have been the result of natural changes over time.
   

MBCT may be an effective intervention for cancer survivors and carers who are willing to make a time commitment for sessions and homework. Further research is warranted.

To compare the effectiveness of an integrated treatment program for major depression in patients with cancer with usual care

This study enrolled patients with major depression from three cancer centers. Patients were randomly assigned in a one-to-one ratio to either the standard care for depression or an intervention group. The intervention consisted of a multicomponent treatment program. This collaborative care model was expanded to include integration with the patients' specialist medical care. Potential participants were identified by the depression screening offered to all patients attending the selected National Health Service clinics in Scotland. A database software program randomized participants to the standard care or intervention groups. In the standard care group, the primary care physician and oncologist were informed of the diagnosis of major depression and asked to treat their patient accordingly. In the intervention group, the physicians were informed of the diagnosis and the participant saw a specially trained nurse under the supervision of a psychiatrist. This program was an intensive, collaborative care-based program specifically designed to be integrated with the patient’s cancer treatment.

• N = 500  
• AGE = Not available
• MALES: Not available  
• FEMALES: Exact numbers not available, but greater than half of patients were female
• KEY DISEASE CHARACTERISTICS: Majority were women with breast or gynecologic cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Participants were receiving adjuvant treatment or follow-up

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Scotland, United Kingdom

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care 

Randomized, controlled trial comparing a standard treatment and an intervention

• Symptom Checklist Depression Scale (SCL-20) (self-reported)
• Primary outcomes were measured at 24 weeks.  
• Treatment response was defined as a reduction of at least 50% in depression severity from baseline.
• Secondary response was defined as an average depression score over 24, 36, and 48 weeks.
• Tertiary outcomes were anxiety, pain, fatigue, social, role functioning, overall health, and quality of life.

From 2008 to 2011, 253 patients were placed into the intervention group and 247 were placed in the standard of care group. Baseline characteristics did not differ between groups. Rates of antidepressant prescriptions at minimum effective doses and dose adjustments were higher in the intervention group. Very few patients from either group received formal psychological treatment from mental health professionals. The primary outcome of treatment response was achieved by 62% of patients in the intervention group compared to 17% of patients in the standard care group. The odds ratio was eight to five (95% confidence interval, p < .0001). The intervention was better than standard care for all secondary and tertiary outcomes. The mean additional cost per patient of providing depression care was in the 95% confidence interval.

A statistically significant number of patients had a clinical response in the intervention group versus the standard of care. This group also had a much greater improvement in anxiety, pain, fatigue, functional ability, quality of life, and perceived quality of care.

• Risk of bias (sample characteristics)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: The sample was mainly women receiving adjuvant treatment or follow-up care. The trial was completed in one particular healthcare system. The researchers were not able to determine whether one component of the intervention was more important than others. Patients were followed for only one year. Long-term outcomes are unknown.

Nurses are able to  play a major role in screening for depression and are able to provide (with training) interventions to help patients improve the symptoms of depression. Nurses also can provide longitudinal follow-up in assessing the improvement of depression. Attention to and treatment of depression in patients with cancer is effective. Nurses can advocate for sufficient attention to depression screening and management.

To compare two topical agents (Calendula Weleda^® cream and Essex^® cream) in reducing the risk of severe acute radiation skin reactions in women receiving adjuvant radiation therapy for breast cancer

Patients randomly were assigned one of two creams (Calendula or Essex) and applied a thin layer twice daily from the beginning of radiotherapy through two weeks after their final radiation treatment or until the skin reaction healed. The cream was not applied within two hours of the radiation treatment. Patients were advised to wash daily with nonperfumed soap and told not to apply other topicals in the radiation field. Patients completed questionnaires related to quality of life (European Organization for Research and Treatment of Cancer [EORTC]-QLQ C30), sleep (MOS), and symptoms (e.g., pain, tenderness, burning, pulling, itching) related to the radiation field on a visual analog scale.

• N = 411    
• MEAN AGE = 58 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with breast cancer who had previous partial or modified radical mastectomy and were to undergo adjuvant external beam radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Treatment fractions were 2Gy per day, five days per week, up to 50Gy total dose, or 2.66Gy per day, five days per week, up to a total dose of 42.56Gy. All patients younger than 40 years had a boost of 16Gy in 2Gy per fraction. Treatment was photons 6MV or in combination with 15MV or 18MV.

• SITE: Single institution  
• SETTING TYPE: Radiation unit  
• LOCATION: Department of Oncology at Karolinska University Hospital

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

• Two arm, blinded, randomized phase III trial

• Primary endpoint statistics: Fisher’s exact test
• Secondary endpoint: Linear regression
• The primary endpoint of this study was the difference in the proportion of patients with severe acute radiation skin reactions using the Radiation Therapy Oncology Group (RTOG)/EORTC scale for radiation morbidity scoring criteria.
• Patients were evaluated by radiation therapy nurses who had received education on the use of the RTOG/EORTC scale in the form of 90-minute workshops and lectures.
• Assessment took place on three occasions: the first day of radiation treatment, the last day of treatment, and at a follow-up visit 5–17 days after the final radiation treatment.
• The secondary endpoint of this study was patient-reported outcomes (using quality of life and sleep questionnaires and symptom ratings on a visual analog scale).

Researchers found no statistically significant difference in severe acute radiation skin reactions in the group using Calendula cream versus the group using Essex cream (a water-based topical emollient, which is the standard of care in that institution.) Severe acute radiation skin reaction (RTOG/EORTC grade less than or equal to 2) was 23% in the Calendula group versus 19% in the Essex group. There were no differences in patient-reported outcomes in terms of pain, burning, itching, pulling, or tenderness at the radiation site. However, there was a statistically significant difference in patient evaluation of application and absorption of the cream in favor of Essex cream.

There was no difference in severe acute radiation skin reactions in women with breast cancer using Calendula cream or Essex cream during radiation therapy.

• Key sample group differences that could influence results
• Other limitations/explanation: The timing of the follow-up visit was variable at a length of 5–17 days post-radiation therapy. Treated skin heals over time, and a more acute skin reaction is likely at five days post-treatment versus two weeks or longer off treatment.

Patients with breast cancer undergoing curative radiation therapy may experience a less severe acute radiation skin reaction using twice daily application of Calendula cream or an aqueous-based cream. Future studies could include patients with other types of cancer and different treatment fields to compare benefits of these topical emollients.

To evaluate the effects of reflexology compared to the effects of massage or usual care on the cancer-related quality of life, relaxation, mood, and adjustment of women with newly diagnosed early breast cancer

Women were randomized to one of three interventions: reflexology plus self-initiated support (SIS), scalp massage plus SIS, or SIS (treatment-as-usual control group). Patients receiving reflexology or massage received eight one-hour sessions at weekly intervals for eight weeks, beginning seven weeks after surgery. Patients were assessed by a nurse who was blinded to treatment allocation. Assessments occurred before randomization (week 6 after surgery), 18 weeks after surgery, and 24 weeks after surgery.

• The sample was composed of 183 patients. Sixty patients were in the reflexology group, 61 were in the massage group, and 62 were in the SIS group.
• In the reflexology group, mean patient age was 59.37 years (SD = 10.46 years); the age range was 32–81. In the massage group, mean patient age was 57.70 years (SD = 10.12 years); the age range was 36–76. In the control group, mean patient age was 59.36 years (SD = 10.23 years); the age range was 36–77.
• All patients were female.
• All patients had early-stage breast cancer.
• Patients were randomized six weeks after breast surgery. Randomization was not controlled for treatment type. The reeport suggests that most participants were receiving chemotherapy, radiation therapy, or both; the sample description does not make type of treatment clear.

• Multisite
• Outpatient
• United Kingdom

Phase of care: active treatment

Randomized controlled clinical trial

• Functional Assessment of Cancer Therapy-Breast (FACT-B)
• Trial Outcome Index (TOI)
• Mood Rating Scale (MRS)
• Hospital Anxiety and Depression Scale (HADS)
• Complementary Therapies Questionnaire (CMQ)
• Structured Clinical Interview for DSM-IV-TR disorders (SCID-IV-TR)

• At baseline authors noted no significant difference between groups on any measure or demographic variable.
• At the primary end point (week 18), TOI scores for the three groups differed significantly: Massage patients had significantly higher scores on the TOI (indicating better quality of life) than those receiving SIS (p < 0.03). MRS scores at the primary end point showed that massage and reflexology patients were significantly more relaxed (p < 0.0005) than were SIS patients.
• HADS scores did not differ significantly among the three groups.
• At the second end point (week 24), reflexology patients were significantly more relaxed (p < 0.02), according to TOI, than were SIS patients.

At the two end points, authors noted no significant differences in depression scores. This indicated that neither intervention had any impact on depression or anxiety.

• The study had a risk of bias due to no appropriate attentional control.
• Subjects had low levels of symptoms of interest, which may have affected the ability of the interventions to demonstrate impact.

Findings do not support the effectiveness of reflexology as a means of reducing depression or anxiety.