To test the feasibility, cultural sensitivity, and effect of an expressive writing intervention.

Patients completed baseline assessments by mail and received three envelopes that were to be opened according to labels for study week. They were asked to write about their deepest feelings about having cancer and about the strategies they used for coping. They were to write for 20 minutes each week. After the last writing assignment and three and six months later they completed study questionnaires by mail. Focus group interviews were also conducted.

• The sample was comprised of 19 women.   
• Mean age was 54 years (range 31–83).
• Patients had stage I and II breast cancer. 
• Mean time since diagnosis was two years.
• Patients has been in the United States an average of 19 years.
• Most patients had a household income of less than $15,000, and more than 90% had a high school education.

 The study used a quasiexperimental, pre-/post repeated measures design.

• Functional Assessment of Cancer Therapy–Breast (FACT-B)
• Physical symptoms checklist
• Positive and Negative Affect Score (PANAS)
• Posttraumatic Growth Inventory (PTGI)
   

At three months, the change in fatigue showed a partial eta² of 0.066, and eta² for posttraumatic stress was 0.208. There was 100% compliance in completing writing assignments. Patients commented that the activity was meaningful for Chinese women.

 Findings suggested that expressive writing is a feasible and acceptable intervention for Chinese American women.

• The study had a small sample size, with less than 30 patients.
• The study had risks of bias due to no control group, no blinding, no random assignment, and the sample characteristics.*
• Unintended interventions or applicable interventions not described would have influenced the results.
• Outcomes reporting was selective.
• Patient withdrawals were 10% or greater.
• * The activity may not be acceptable to other cultural groups or to men. There was a 15% drop-out rate, suggesting that not all women appreciated the approach. The authors provided no confidence intervals for the statistics reported. Repeated measures may have given testing threat to validity.

Expressive writing appeared to be an acceptable intervention for these women. The study design and sample size did not allow for any firm conclusions about effects to be drawn.

To test the effect of emotionally expressive writing in a randomized, controlled trial of patients with metastatic breast cancer (MBC) and to determine whether the effects of the intervention varied as a function of perceived social support or time since metastatic diagnosis.

The sample was recruited from several sources; all contact occurred via telephone, mail, or email. Patients were randomized to either an emotional or control writing condition and were mailed a packet of sealed envelopes. Trained research assistants telephoned women at the beginning of each of the four writing sessions within a three-week interval to read instructions and called back 20 minutes later to ask the women to stop writing. The women mailed the essays to the research office at the end of each session for analysis. Outcomes were measured three months after the final writing.

• The sample was comprised of 62 women.
• Mean age was 53.8 years (standard deviation = 10.3 years; range 29–78).
• Patients had stage IV MBC.
• Patients could be on or off treatment.

• Single site
• Home
• California

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for end of life and palliative care.

The study was a randomized, controlled trial.

• Center for Epidemiologic Studies Depression Scale (CESD)    
• 7-Item Intrusion Scale
• Impact of Events Scale (IES)
• Negative Somatic Symptoms (Pennebaker 1982)
• Pittsburgh Sleep Quality Index (PSQI)
• Demographic/medical variables
• Questionnaire reactions to participation at three months

No significant differences existed between the two experimental conditions on demographic/medical variables, depression, intrusive thoughts, or sleep disturbances. There were no main effects for the experimental condition to predict intrusive thoughts. Perceived emotional support at study entry interacted with the experimental condition to predict IES-Intrusion (F [1, 56] = 11.61; p = 0.001). For women with a decreased level of emotional support at entry, the effect of the experimental condition was significant (p = 0.002). There was no effect on sleep in newly diagnosed patients but increased sleep disturbances for women who had been diagnosed more than 4.7 years.

Contrary to the hypothesis, expressive writing did not reduce psychological distress or improve physical health as quantified by fewer sleep disturbances and somatic symptoms.

• The study had a small sample size, with less than 100 patients.
• The study lacked heterogeneity and was white.
• Physical health measures relied on self-reports.
• The study was underpowered to detect an effect in the subset of women who had not previously participated in a cancer support group or talked with a mental health professional about cancer.

Expressive writing may be helpful for a subset of patients with MBC (those with low levels of social support and recently diagnosed) and contraindicated for others (those living longer with the diagnosis). Further studies should explore alternative writing topics, such as perceived benefits of the cancer experience.

To test the effects of emotionally expressive writing versus disease-related writing on patients with metastatic breast cancer; to determine whether the effects of expressive writing vary as a function of perceived social support or time since diagnosis of metastasis   

Investigators used three sources of recruitment: a larger study, flyers, and advertising on a website and Listserv. All contact with patients was via telephone, postal mail, or email. Participants completed baseline assessments, which gathered data about demographics and emotional support. Investigators collected saliva samples. Patients were randomized to either the emotional or control writing condition, and patients received information about the exercises. Patients were scheduled to participate in four 20-minute sessions that occurred at patients' convenience within a three-week interval. A research assistant monitored compliance. After each session, a patient mailed her writing to the research office. At study entry and three months after the final writing session, a by-mail questionnaire measured outcomes according to stated instruments.

• The sample was composed of 62 participants, 31 were in the expressive writing group and 31 were in the control group.
• Mean patient age was 53.8 years (SD = 10.3 years). The age range was 29–78 years.
• All participants were female.
• All patients had stage IV metastatic breast cancer.
• Participants were eligible for the study if they could complete the writing exercises and assessments in English and if they were undergoing any medical treatment for cancer.
• Of all participants, 74% were college-educated, 71% were married or partnered, 87% were white, and 78% were not working outside the home. On average, participants had been diagnosed with breast cancer 7.9 years ago. Most had received the diagnosis of stage IV cancer 3.3 years ago. The cancer of most participants had metastasized to the bone.
• Of all participants, 72% had had experience with support groups, 63% were working on cancer-related issues with a mental health professional, and 63% had journaled about their cancer experience.
   

• Multisite.
• Home.
• California (October 2006–April 2009); however, information was posted online and on a Listserv.

• Phases of care: multiple phases of care
• Clinical applications: supportive care (end-of-life and palliative care), late effects and survivorship
   

Randomized controlled trial

• Center for Epidemiologic Studies Depression Scale (CESD), a 20-item scale to assess the frequency of depression symptoms in the past week.
• Seven-item intrusions subscale of the Impact of Event Scale (IES), to measure the extent of distress caused by cancer-related intrusive thoughts over the past week.
• Instrument, developed by Pennebaker (1982), to measure negative somatic symptoms. The instrument, shown to be responsive to the expressive writing intervention, asks respondents to report the number of days in the past month on which they experienced each of nine somatic symptoms.
• Pittsburgh Sleep Quality Index (PSQI), to assess sleep quality over the past month and yield a total sleep disturbance score. Scores of 5 and above indicate clinically significant sleep disruptions. This scale has been used as an outcome measure in previous trials of expressive writing as practiced by patients with advanced cancer.
• Items adapted from a tool by Alferi et al. (2001), to measure perceived emotional support.
• Questionnaire, to gather demographic data.
   

• Investigators observed no significant main effects of the experimental condition, with respect to demographic or cancer-related variables or experience with cancer, support groups, psychotherapy, or journaling. 
• Investigators reported no significant group differences, at study entry, regarding symptoms of depression, intrusive thoughts, sleep disturbance, somatic symptoms, or perceived emotional support.
• A significant condition, correlated with social support interaction, emerged regarding intrusive thoughts: Expressive writing was associated with reduced intrusive thoughts in women reporting low emotional support. The significant condition correlated with time, because investigators also observed an interaction between the measure of metastatic diagnosis and the measures of somatic symptoms and sleep disturbance. Relative to the control, participants in the intervention who were more recently diagnosed had fewer somatic symptoms. Intervention participants with longer diagnosis duration exhibited increases in sleep disturbance.
• Among outcome variables, only scores reflecting depression symptoms correlated significantly with intrusive thoughts (r = 0.56, p < 0.001), sleep disturbance (r = 0.30, p = 0.019), and somatic symptoms (r = 0.53, p < 0.001). None of the correlations between the other three outcome variables was significant.

Expressive writing did not produce reduction in psychological distress or improvement in physical health. The intervention may be beneficial for a subset of patients with metastasis and contraindicated for other patients.

• The study had a small sample size, with fewer than 100 participants.
• Participants were predominantly white and well educated.
• Outcome measures related to physical health relied on self-reporting.
• The study was underpowered in regard to detection of main effects. Study design should have included alternative writing topics or a control topic unrelated to cancer.
   

Expressive writing may be of benefit to a certain subset of patients. The intervention is cost-effective and an activity that patients with low levels of social support can do. Future study should apply the expressive-writing approach to vulnerable, underserved, and understudied populations and offer broader topics for expressive writing (e.g., benefits of the cancer experience, a topic unrelated to cancer). Investigators should provide writing supplies. Future research should consider privacy protections (possibly from family members), especially in cultures that place great value on the privacy of written material.

To test the hypothesis that d-methylphenidate (d-MPH) would produce a significant reduction in fatigue compared to placebo.

Patients were randomized to receive the study drug or an identical appearing placebo; packaging and labeling were done by a pharmacist not involved in other aspects of the study. Patients received 5 mg of the drug twice daily by mouth. Measures were performed at baseline and at weeks 1 and 8, which was the end of the double-blind treatment phase. Weekly dose modifications were performed at the investigators' discretion based on the magnitude and duration of response assessed weekly by Clinical Global Improvement–Impression (CGI-I) scores. The maximum allowable total daily dosage was 50 mg/day in two to three doses per day.

• In total, 154 patients (94.1% women) with cancer who met the proposed International Classification of Diseases, 10th Revision (ICD-10) criteria for a diagnosis of cancer-related fatigue were included. 
• Mean age was 52.8 years (standard deviation = 9.3 years) (range 18–70).
• Patients had multiple types of cancer, excluding primary or metastatic brain tumors. The highest proportion of patients had breast or ovarian cancer.
• Patients were included if they
  • Were treated with at least four cycles of chemotherapy concluded at least two months prior to study entry
  • Had no concurrent cancer treatment, history of major psychiatric illness, learning or attentional deficitis, or prior treatment with the study drug. 
  • Were nonpregnant and nonlactating women.
• Additional screening and criteria were established for depression and cognitive function. 

• Multisite
• Twenty-four academic or community-based cancer treatment centers in the United States

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

• CGI-I scale
• Functional Assessment of Chronic Illness Therapy–Fatigue subscale (FACIT-F)
• Swanson, Nelson, and Pelham Attention Deficit/Hyperactivity Scale (SNAP)
• High Sensitivity Cognitive Screen (HSCS)
• Eastern Cooperative Oncology Group (ECOG) performance status
• Mini-Mental State Exam (MMSE)

D-MPH–treated patients had lower ECOG performance status scores than placebo-treated patients (p = 0.03), indicating better performance. The mean highest dose achieved in d-MPH–treated patients was 27.7 mg/day (range 10–70). A significantly greater improvement in FACIT scores from baseline was seen in patients who received d-MPH compared to placebo at week 8 (p = 0.02). In the study group, there was a mean 10.5-point score reduction in the d-MPH group. Reduction in fatigue was seen at an average dose of 27.7 mg/day of the study drug. All patients had reduction in CGI scores, indicating decreased severity of symptoms from baseline to week 8. Improvement in these scores was seen in a significantly greater percentage of those given d-MPH (p = 0.02). The most frequent adverse events were headache, nausea, and dry mouth in the treatment group and headache, diarrhea, and insomnia in the placebo group. There was a higher rate of adverse events in the d-MPH group. Eleven percent of the treatment group experienced serious adverse events that led to study discontinuation. Events that led to discontinuation were nausea, vomiting, feeling jittery, and abnormal electrocardiogram.

D-MPH treatment in an individualized dosing regimen based on therapeutic response and side effects was associated with a significant improvement in fatigue.

• There was a predominance of breast and ovarian cancers in the sample, suggesting that findings may not be generalizable to broader populations of patients.
• Baseline performance status was better in the experimental group than in the placebo group. The potential effect of this difference was not analyzed or addressed.
• The sample did not include patients in active treatment, so the findings are not readily applicable in that situation.
• The study duration was only eight weeks, so the effect of this intervention over the longer term is not clear from these findings.

Future studies need to be performed that address a broader range of patient types. The effectiveness of d-MPH in combination with other interventions, such as exercise, should be examined.

The study's primary aim was to evaluate the potential therapeutic effect and safety of dexmethylphenidate (d-MPH) in the treatment of patients with chemotherapy-related fatigue. Its secondary aim was to examine the impact of d-MPH on cognitive functioning.

Participants were randomized to a placebo group or an intervention group receiving 5 mg of d-MPH twice daily (10 mg/day total).

• The total number of participants was 154.
• There were 76 participants in the intervention group and 78 in the placebo group.
• The average participant age was 52.8 ± 9.3 years.
• 94.7% of the participants were female and 5.3% were male.
• The majority of participants had breast or ovarian cancer. 

The study took place across 24 academic and community-based cancer centers.

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

Cognitive measures were taken with the

• Mini-Mental State Examination (MMSE) for global cognitive functioning
• High Sensitivity Cognitive Screen (HSCS) for memory, language, attention, concentration, visual motor, spatial awareness, and self-regulation
• Modified Swanson, Nelson and Pelham Attention Deficit/Hyperactivity Scale (SNAP).

Other measures were taken with the

• ICD-10 Criteria for fatigue
• Beck Depression Inventory (BDI) for depression
• Clinical Global Impression Scale (CGI-S) for severity of illness
• Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-F) for chronic illness and quality of life specific to fatigue symptoms
• ECOG performance status for general well-being. Scores range from 0 (indicating perfect health with no restriction of activities) to 5 (indicating death).

The primary outcome of focus was fatigue. Participants treated with d-MPH had significant improvement in fatigue symptoms at week 8 on the FACIT-F (p = 0.02) and on the CGI-S (p = 0.02). The d-MPH treatment group had higher drug-related events (63% vs. 28%) and greater discontinuation of medication (11% vs. 1.3%) than the placebo group. Cognitive function was not significantly improved.

d-MPH can be of benefit in the treatment of fatigue. However, results do not support d-MPH-mediated reduction in cognitive impairment in adult patients with cancer after chemotherapy.

• The study was underpowered to determine an effect on cognitive functioning.
• HSCS has been reported to be susceptible to practice effects and therefore may have underestimated the level of cognitive impairment in participants.
• The small number of men and the fact that most participants had diagnoses of breast or ovarian cancer limit generalizability.

To show the addition of naloxone improves constipation symptoms in patients with non-malignant pain receiving high-dose oxycodone prolonged release (PR).

Patients were randomized to receive either oxycodone PR and naloxone PR or oxycodone PR plus matched oxycodone PR/naloxone placebo. Patients had oxycodone PR titrated to an effective analgesic dose over a 7- to 28-day period and were converted to the study laxative, bisacodyl. Oxycodone immediate release was used as pain rescue medication. Patients were eligible to participate in a 52-week open-label extension. Mean pain over the past 24 hours and bowel function were measured at each study visit and in patient diaries on a daily basis.

• The study reported on a sample of 222 patients (81.5% female and 18.5% male).
• Mean age was 56.2 to 57.5 years (SD = 10.5) across both study groups.
• Patients with cancer-related pain were excluded.
• Predominant problems were musculoskeletal and connective tissue disorders.
• Patients required 60 to 80 mg oxycodone PR equivalent per day and had constipation.

• Multi-site
• Outpatient
• Germany

This was a double-blind, placebo-controlled, randomized study with an extension phase.

• Bowel Function Index (BFI)
• Pain Intensity Scale (numeric rating 0-10)
• Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYMN)
• Subjective Opioid Withdrawal Scale (SOWS)
• Patient diary

• During the first four weeks of the study in the double-blind phase, the difference in mean BFI scores was significantly different (PR = -14.9, p < 0.0001, 95% confidence interval [-17.9, -11.9]) in favor of the oxycodone-PR/naloxone-PR group.
• There were no differences between groups in mean pain measures.
• There were no substantial differences between groups in supplemental analgesic use.
• Significantly fewer patients in the oxycodone-PR/naloxone-PR group took laxatives (p = 0.0009).
• Most common events were nausea, pain, and headache in both groups.
• Withdrawal scores were stable, low, and similar between groups.

Oxycodone PR/naloxone PR was superior to oxycodone PR at improving bowel function and symptoms of constipation. That improvement was achieved without affecting the analgesic efficacy of the oxycodone component.

• The study period of 12 weeks is limited in the setting of much longer-term opioid use.
• Although the study design specified a maximum number of laxative rescue doses, actual rescue laxatives taken were not described and were not analyzed between the two groups.
• Patients with cancer-related pain were specifically excluded; therefore, application to that group is not clear.

The combination of oxycodone PR/naloxone PR in patients with cancer warrants investigation to determine potential benefits in reducing opioid-induced constipation in this population.

The focus of the study was to evaluate the role of glutamate supplementation in preventing paclitaxel-induced peripheral neuropathy.

Patients were randomized to receive daily placebo or 500 mg glutamate supplementation beginning on the first day of chemotherapy. Treatment was continued throughout six cycles of chemotherapy and for an additional three weeks. Patients were assessed for neuropathy with serial electro-diagnostic measurements at baseline and at the end of the study.

The total sample consisted of 43 women with a median age of 59 years (range of 35–80 years) who were diagnosed with gynecologic cancers and were receiving paclitaxel.

The study was conducted in multiple outpatient sites throughout Israel.

Phase of care

• Active antitumor treatment

The study had a double-blind, placebo-controlled randomized trial design.

• Various electro-diagnositic measurements were used to assess nerve conduction and sensory conduction velocity.
• The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) was used for assessment, as was a 0–3 scale to measure change in symptoms.

An indication of peripheral neuropathic toxicity was lower in patients receiving glutamate, but the difference was not statistically significant. However, significantly lower pain levels were noted in the glutamate group (p = 0.011). No differences were found between groups regarding electro-diagnostic measurements.

The study does not provide strong support for the benefit of glutamate in the prevention of peripheral neuropathy in patients receiving paclitaxel. No firm conclusions can be drawn due to study limitations.

• A small sample size (less than 100).
• The questionable validity and reliability of the three-point assessment scale.
• Findings may not be generalizable to patients receiving other chemotherapeutic agents.
• Of the 67 patients randomized, the consort diagram shows a final sample of 43; however, results are only reported for 38 patients. Actual sample and reasons for withdrawal are not well explained.

The findings suggest that glutamate does not prevent peripheral neuropathy during treatment with paclitaxel. Conclusions are limited due to study deficiencies.

To determine if an educational video and/or booklet for people with advanced cancer and pain can improve pain management and quality of life and decrease anxiety, pain, and pain interference

Patients were recruited from multiple oncology and palliative care clinics and were randomly allocated to one of four treatment groups. Patients in group 1 received standard care only. Those in group 2 received standard care plus a booklet. In group 3, patients received standard care plus a video. Group 4 patients received standard care plus a booklet and video. The video depicted patients, a caregiver, and health professionals talking about cancer pain and management. The booklet, published by the New South Wales Cancer Council, contained text and cartoons about pain and its management. Text was written for a reading age of 12 years. Patient assessment was done at baseline and at weeks 2 and 4 after study entry.

• The sample was composed of 140 patients.
• Mean patient age was 69 years.
• Of all patients, 57% were female and 43% were male.
• The sample included a variety of cancer types, with the most frequent being breast and lung cancers. In regard to other patient characteristics, 10% of patients had university-level education, 73% were married, and 77% were in an urban setting. All patients had a pain rating greater than or equal to 2. At baseline, 77% patients were on opioids and 22% were receiving inadequate pain control.

• Multisite
• Outpatient
• Australia

Randomized controlled trial

• Barriers Questionnaire
• Wisconsin Brief Pain Questionnaire
• Pain management index, a composite of the analgesic strength rating and worst-pain rating
• Uniscale for the assessment of global quality of life
• Hospital Anxiety and Depression Scale
• Patients' daily diaries of pain

Barriers were low in all groups at baseline. The barriers scores dropped more in the intervention groups than in the control group, but differences from control or between the other three groups were not significant. There was a significant difference (p < 0.05) in the addiction subscale change in the booklet-only and video-only groups. Authors reported a significantly higher change in average pain (p = 0.0214) between the control and video-and-booklet groups. Authors noted marginal differences in average pain between groups in all other combinations. Reduction in worst pain was significantly greater (p = 0.05) in the video-and-booklet group than in the control group. The size of the differences was small (–1.12). Authors noted no other between-group differences. The presence of a partner increased the effect of any intervention on outcomes (p = 0.004, p < 0.01). According to the pain management index, there was no difference between groups in regard to pain management. Authors observed no difference between groups in regard to anxiety or depression, and they observed no significant change in anxiety or depression. All groups reduced overall consumption of opioids.

In this study a self-administered educational intervention consisting of a booklet and video was associated with a reduction in average pain, worst pain, and fear of addiction.

• The study had a risk of bias due to no blinding.
• The duration of the study was relatively short, four weeks.
• Baseline pain scores of 2 or higher would result in inclusion of patients with only mild pain. Baseline pain intensity data are not provided.
• Authors do not state how much relevant education was included in standard care. Variability among providers could have resulted in substantial differences among subjects.

Findings suggest that standardized education that includes a video and booklet can be helpful in pain management. The effectiveness of the intervention is due, presumably, to greater patient and caregiver involvement in pain management. This study showed that the combination of a booklet and video, along with standard care, was the most effective intervention. The content of each may have reinforced the other. Use of a standardized set of educational materials, such as those used in this study, can be a practical, efficient way to supplement other interventions to manage pain, may be effective in involving patients more directly in pain management, and may help to remove barriers to and misconceptions about pain management.

To determine how women with stage 1 breast cancer-related lymphedema (BCRL) are affected by yoga

• N = 23  
• AVERAGE AGE = 57.6 years (SD = 10.5 years, range = 34–80 years) 
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stage 1 unilateral arm BCRL
• OTHER KEY SAMPLE CHARACTERISTICS: Completed treatment for breast cancer (surgery, radiotherapy, and chemotherapy) at least six months prior to study; aged greater than 18 years; sufficient English literacy to provide informed consent; exclusion criteria included recurrent cancer, infection, complex lymphedema therapy, pregnancy, pacemakers (would affect bioimpedance spectroscopy readings), and severe psychological illness

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

• PHASE OF CARE: Multiple phases of care

Multi-center, randomized, controlled pilot trial using a parallel design with participants allocated to the intervention or control groups on a 1:1 ratio

• Primary outcome measures were arm volume of lymphedema (measured by circumference) and extracellular fluid (measured by bioimpedance spectroscopy).
• Secondary outcome measures were tissue induration (measured by tonometry), levels of sensations, pain, and fatigue (limiting effects measured by a Visual Analog Scale [VAS] and quality of life based on the Lymphoedema Quality of Life Tool [LYMQOL]).

At week 8, the intervention group had a greater decrease in tissue induration in the affected upper arm compared to the control group (p = 0.050) and a greater reduction in the symptom subscale for quality of life (p = 0.038). There was no difference in arm volume of lymphedema or extracellular fluid between groups at week 8. However, at week 12, arm volume increased more for the intervention group than the control group (p = 0.032).

The outcomes of this small pilot trial provided preliminary evidence that an eight-week Satyananda yoga intervention did not exacerbate lymphedema and improved tissue induration ing the affected upper arm as well as quality of life subscale symptoms. However, the fact that these improvements were not maintained at the one-month follow-up when arm volume was increased suggested that yoga needs to be ongoing. This is one of few studies that addresses tissue induration.

• Small sample (< 30)
• Baseline sample/group differences of import
• Other limitations/explanation: Higher body mass index of the participants in the yoga group compared to the control group at baseline, which may have confounded the results

Yoga may reduce tissue induration in the upper arm affected by lymphedema and decrease its associated symptoms. However, additional research trials with longer durations, higher levels of lymphedema, and larger numbers are warranted before definitive conclusions can be made.

To test the effects of yoga on health-related quality of life, life satisfaction, cancer-related fatigue, mindfulness, and spirituality compared to conventional therapeutic exercises during (neo)adjuvant cytotoxic and endocrine therapy in women with stages I–III breast cancer

In a randomized controlled trial (N =119) (with data from 92 used for data analyses), women with breast cancer undergoing oncological treatment were randomly enrolled in a yoga intervention (YI) (n = 45) or a physical exercise intervention (PEI) (n = 47). Measurements were obtained before (t0) and after the intervention (t1), as well as three months after finishing the intervention (t2) using standardized questionnaires.

• N = 92   
• AGE = 40–62 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy, hormonal therapy
• KEY DISEASE CHARACTERISTICS: Breast cancer stage I–III 
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria were (a) acute febrile or psychiatric diseases or (b) regular practice of yoga or experience practicing yoga

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Yoga at the center \"Yoga München GbR\" in Munich, physical exercise at the center \"Gesund. Reha rechts der IsarGmbH\" in Munich, and exercise at home

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial with active control

• Cancer-specific European Organization of Research and Treatment of Cancer Core Quality of life (QLQ-C30) questionnaire for health-related quality of life
• Brief Multidimensional Life Satisfaction Scale
• 15-item Cancer Fatigue Scale (CFS-D)
• 14-item Freiburg Mindfulness Inventory (FMI)
• 15-item version of SpREUK questionnaire for spiritual attitudes and coping with Illness

Statistically significant results were found on most functional scales of the EORTC, which indicated the spontaneous recovery of patients’ quality of life after chemotherapy and/or radiation. The global health, role, and social functioning of patients in both groups improved significantly, yet neither group significantly differed from the other in these variables. Fatigue, dyspnea, appetite loss, constipation, and diarrhea improved in both groups. For “nausea and vomiting” and “pain,” significant changes were observed over time. No difference existed in life satisfaction, cancer-related fatigue, spirituality, and mindfulness between the groups.

High drop out rate may be related to the number of measurements. One of the concerns was that patients in treatment were having difficulty with the exercise and yoga programs thought to be from the side effects of the treatment. Further study focusing on one or two areas would be beneficial.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• The number of lessons varied from 5 to 12, and the time lapse varied from 6 weeks to 25 weeks, which was not considered in the evaluation of the program.

The authors felt that this study may have been accepted by patients post-treatment or by using other forms of yoga. Self-care is becoming more common today, and yoga something you can do for yourself. Further investigation should be conducted to see how effective yoga is for patients with cancer.