To assess the role of an neurokinin 1 (NK1) antagonist in antimetic protection in combination with granisetron and dexamethasone in patients receiving high-dose chemotherapy (HDC)

• Patient undergoing multiple days of HDC received granisetron, dexamethasone, and aprepitant during chemotherapy and two days after the completion of chemotherapy.
• Patients were receiving two HDC regimens for at least two days.
  • Melphalan, 70 mg – 100 mg/m², days 1-4, followed by peripheral blood stem cell translant (PBSCT)
  • Paclitaxel, carboplatin, etoposide, and ifosfamide

• This study consisted of 64 patients.
• Patient mean age was 42.3 with a range of 21–67. The percentage of patients younger than age 35 was 18%.
• The study consisted of 52 male patients (81.2%) and 12 female patients (18.8%).
• Patients had been diagnosed with multiple myeloma (MM) (32.8%), thymic cancinoma (6.3%), testicular cancer (35.9%), sarcoma (23.4%), and unknown primary (1.6%).
• Additionally, 9.4% of patients had received previous gastrointestinal (GI) surgery, 7.8% had a history of alcohol abuse, 7.8% had a history of loss of appetite, 6.3% had preexisting nausea, 1.6% had preexisting dizziness, and 14.1% had anxiety.

This study was conducted at a single site at a university hospital in Halle, Germany.

• All patients were in active treatment.
• The study has clinical application for elderly care.

This was a nonrandomized, single-center, observational trial.

• Complete response (CR) was defined as no vomiting and no use of rescue medications in the overall phase (days 1 until 5 days postchemotherapy).
• Nausea and vomiting were recorded daily on a special documentary chart.  All adverse events were recorded to evaluate the tolerability and were graded according to the common terminology criteria.
• All other drugs administered to the patient during the study were recorded.

• For the overall evaluation phase, the primary endpoint of CR was achieved with 40 (63%) patients.
• For the acute phase (during days of HDC), CR was achieved in 53 patients (83%).
• For the delayed phase (days 1 through 5 after the end of HDC) CR was seen in 45 patients (70%).
• Acute nausea was observed in 13 patients (20%), delayed nausea in 24 patients (24%), and overall nausea in 30 patients (47%).
• At the day of retransfusion of stem cells (second day of delayed phase in all HDC groups), the CR rate was 84% and the rate of nausea was 19%.
• The authors concluded that randomized studies may be necessary to add aprepitant to guidelines.

The study demonstrated a good toxicity profile with the addition of aprepitant to the standard antiemetic regimen, with improvement in the prevention of chemotherapy-induced nausea and vomiting (CINV) during multiday, high-dose regimens.

• The study had a small sample with fewer than 100 patients.
• Tools or scales used to measure nausea were not reported.
• A description of how vomiting and nausea were recorded on the special documentation form was not included.
• The authors did not describe how the nurses were trained to use the form and whether it was only recorded by registered nurses.
• Methodological limitations exist with comparing the results with those only from the current literature.

• The addition of aprepitant to standard antiemetic regimens during multiday HDC administration provides additional protection for both acute and delayed CINV.
• The possible reaction between aprepitant and Ifosfamide was within the reported range of induced encephalopathy (26%, range = 10%–30%).

To investigate the influence of pole walking on arm lymphedema following breast cancer treatment when using a compression sleeve

Pole walking is a walking exercise with the addition of walking poles that simulates the arm motion of cross-country skiing during walking. Subjects participated in pole walking on one occasion for one hour outdoors in a park and on sidewalks for approximately 4 km. Each session was performed similarly and was supervised by the same person. Measurements were made before, immediately after, and 24 hours later.

• The study sample was comprised of female patients aged less than 70 years.
• Arm lymphedema was defined as the affected arm being 5% larger than the contralateral arm, including palpable thickness somewhere in the affected arm compared to the contralateral arm, and the patient's experience of tightness in the affected arm.
• The edema had to be persistent for at least six months.

The study took place at a single site in Sweden.

The study used a pre-post design.

• Both arms were measured with the water displacement method and the contralateral arm was used as a control on each occasion.
• Total arm volume was given in milliliters for both arms.
• Lymphedema absolute volume was calculated as the volume difference between the arms.
• The lymphedema relative volume was calculated in percentage.
• Subjective lymphedema assessments of experience of heaviness and tightness in the affected arm while standing with their arms hanging and no arm sleeve on were used.
• A 100-millimeter visual analog scale used the endpoints ‘‘no discomfort’’ (0 mm) and ‘‘worst imaginable\".

The patients showed no significant difference in total arm volume in the edema arm immediately after pole walking or 24 hours later compared to before walking. Immediately after pole walking, a significant decrease in lymphedema absolute volume and in lymphedema relative volume was found compared to before pole walking. Twenty-four hours later, no differences were found compared to before walking. There were no significant differences in rating of heaviness and tightness on the visual analog scale immediately after pole walking or after 24 hours compared to the rating before pole walking.

A controlled, short-duration pole-walking program can be performed by patients with arm lymphedema using a compression sleeve without deterioration of the arm lymphedema.

• The study had a small sample size (N < 30).
• Out of 42 candidates, 26 participated in the study.
• Participation bias should be advised.

Nurses and clinicians should be aware and encourage women with lymphedema to perform exercises, such as pole walking, which seems not to deteriorate arm lymphedema.

To investigate the effects on intensive pole walking on cardiovascular fitness, subjective assessment, and arm lymphedema in women who were treated for breast cancer

Eight-week exercise period preceded by a two-week control period where subjects were asked not to change anything in daily living. Exercise was self directed 3–5 times/week for 30–60 minutes. Subject pace had to correspond to 70%–80% of estimated maximum heart rate (220-age). Warm up period of 10 minutes included pole walking and light arm exercises. Subjects wore compression garments during exercise and various measurements prestudy, at various intervals, and at the conclusion of the study.

SITE:  Multi-site  

SETTING TYPE:  Outpatient  

LOCATION: Lymphedema unit at Skane University Hospital in Lund and Malmo, Sweden

Quasiexperimental

• Pre-post design: 8 week exercise period preceded by a 2 week control period.
• Arm volume bilateral measurements using the water displacement method and using unaffected arm as a control, cardiovascular fitness was assessed using sub-maximal bicycle ergometer test, which included heart rate monitoring. 
• DASH questionnaire for symptom assessment 
• Visual analogue scale for heainess and tightness in the affected arm
• Two general well-being questions

Statistically significant reduction in total arm volume (p = 0.001), lymphedema absolute volume (p = 0.014), and lymphedema relative volume (p = 0.015), as well as decreased heart rate and rating of tightness in the arms. Both positive and negative influences on well-being were reported.

Moderately intense exercise, such as pole walking, is feasible for patients with breast cancer with lymphedema. Standard precautions and use of compression garments during exercise is advisable. The effects of exercise on cardiovascular health and well-being are consistent with general public. Reduction in arm volume measurements post intervention should be further studied.

• Small sample (< 30)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: Self reported adherence to intervention; measurement of well being and heaviness/tightness in affected arm—subjective assessment—reliability and validity of tools not addressed. Small n value. Further studies are needed.

Patient education

STUDY PURPOSE: To evaluate the evidence regarding beneficial and adverse effects of pharmacologic treatment of neuropathic cancer pain

TYPE OF STUDY: Systematic review

DATABASES USED: PubMed and EMBASE before August 2012; additional studies were identified from study reference lists.

KEYWORDS: Complete search terms are provided.

INCLUSION CRITERIA: Studies involving adult patients with cancer receiving oral analgesics

EXCLUSION CRITERIA: Not specified

TOTAL REFERENCES RETRIEVED = 653

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: American Academy of Neurology evidence classification was used. Authors calculated the absolute risk benefit as the number of patients who received 30%–50% improvement divided by the total number of patients in the treatment group. The fraction of patients who dropped out because of adverse events also was determined. Pain reduction scores were calculated as the percentage of pain reduction from baseline in the study.

• FINAL NUMBER STUDIES INCLUDED = 30
• SAMPLE RANGE ACROSS STUDIES = 1–218
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,267
• KEY SAMPLE CHARACTERISTICS: Not provided

APPLICATIONS: Palliative care

The proportion of patients who obtained improvement of pain with antidepressants was 0.55 (95% CI 0.40–0.69), with anticonvulsants was 0.57 (95% CI 0.44–0.69), with opioids was 0.95 (95% CI 0.93–0.96), and with other adjuvant medications was 0.45 (95% CI 0.33–0.57). Effects for patients with mixed pain were similar. The proportion of patients who withdrew because of adverse effects was 12.6% with antidepressants, 5% with anticonvulsants, 6% with opioids, and 6% with other adjuvant medications.

A substantial proportion of patients achieved pain reduction with adjuvant pain medications, and the proportion of patients who had benefit was higher than those who had to withdraw from studies because of adverse effects. The highest benefit was seen with opioids.

• Whether non-opioids were given in combination with opioids is unclear in this review.
• Controlled and uncontrolled studies were included.
• Many studies were determined to be of low quality.

Numerous limitations in this review make it difficult to evaluate the relative benefits of various approaches evaluated for management of neuropathic pain. Findings do suggest that results with all types of coanalgesics used appear to have benefits that outweigh the prevalence of adverse effects. Findings continue to support the effect and benefits of opioids as a mainstay of pain management for mixed and neuropathic pain.

To provide preliminary prospective evidence of the efficacy of individual agents prescribed for the treatment of breakthrough chemotherapy-induced nausea and vomiting (CINV)

Patients receiving moderately or highly emetogenic chemotherapy received prophylactic antiemetic treatment based on guidelines. If patients experienced breakthrough CINV, their treating oncologist prescribed antiemetics with discretion and the patients were instructed to complete a questionnaire starting at the point in which they took the antiemetic (baseline) and then every 30 minutes for four hours.

• The sample consisted of 96 participants.
• Median age was 58 with a range of 30–86.
• The sample was 45% male and 55% female. Of the patients completing the questionnaire, 26% were male and 74% were female.
• Diagnoses were breast (7%), GI (26%), genitourinary (4%), skin (4%), lung (13%), gynecologic (23%), head and neck (4%), neuroendocrine (1%), sarcoma (3%), and hematologic (15%).
• Patients were receiving  moderately to highly emetogenic chemotherapy.

The study was conducted at a single site at the Mayo Clinic in Minnesota, United States.

All patients were in active treatment.

The study has applications for late effects and survivorship.

This was a prospective, exploratory observation study.

• Patients rated nausea on a scale of 0–10.
• Patients recorded the number of episodes of vomiting and side effects (e.g., agitation, drowsiness [on a scale of 0–10], headache).
• Patients completed nausea and vomiting questionnaires.

Of the total patients enrolled, 28% experienced breakthrough CINV and completed the questionnaire.

The breakthrough medications given were 10-mg oral prochlorperazine (88%) or a 5-HT₃ receptor antagonist (RA) (12%) (specifically, 1 mg granisetron, 8-mg IV ondansetron, 8-mg sublingual ondansetron).

Patients receiving the prochlorperazine experienced a 75% median reduction in nausea after four hours, and vomiting was reduced from 21% to 4%. Of these, 96% reported they would recommend prochlorperazine to other patients (median satisfaction as 8 out of 10).

Patients who received the 5-HT₃ receptor antagonists experienced a 75% median reduction in nausea over the four-hour study period. No vomiting from baseline was reported (satisfaction as 0, 4, and 8 out of 10). The patient who rated satisfaction at 0 recorded complete resolution of nausea by 30 minutes and said would recommend the medication to others, so investigators posited that this patient may have misunderstood the high satisfaction score of 0 rather than 10.

In the patients treated with prochlorperazine, the median drowsiness of 3 at baseline decreased to 2 after four hours. Headache was reported in 20% of patients and decreased to 0% after four hours. Agitation was reported in 20% of patients and decreased to 4% after four hours. Abdominal cramping, dry mouth, tachycardia, blurry vision were also recorded.

In the patients treated with 5-HT₃ RAs, baseline drowsiness of 5 remained unchanged after four hours. One patient did not have drowsiness at baseline but reported drowsiness of 1 after taking the medication. No patients reported headache, agitation, or other toxicities.

Prochlorperazine and 5-HT₃ RAs appeared to be effective breakthrough antiemetic therapies with favorable outcomes. Prochlorperazine is a good choice base on this study as it acts on a different pathway than prophylactic antiemetics. Further randomized, controlled trials would elucidate more effective antiemetic approaches for treating nausea.

• No appropriate control group was included.
• The analyzable sample size was small.
• The study did not provide a clear control for prophylactic antiemetic regimens.

Prochlorperazine has been used for a long time as a rescue medication. This study supports the choice of antiemetic for breakthrough CINV with minimal side effects. Further randomized controlled trials comparing different side effects are clearly recommended.

To assess the feasibility, safety, and effectiveness of acupressure therapy for preventing or reducing chemotherapy-induced nausea and vomiting (CINV) in children receiving chemotherapy

• Patients were randomized to one of two acupressure treatment groups.
  • In group 1, patients wore acupressure wrist bands during first chemotherapy course, no wrist bands during second chemotherapy course, and placebo wrist bands during the third chemotherapy course.
  • In group 2, patients wore placebo wrist bands during first chemotherapy course, no wrist bands during second chemotherapy course, and true acupressure wrist bands during the third chemotherapy course.
• Patients received standard antiemetic therapy as directed by their physician.
• Patients completed questionnaires before and after each chemotherapy course.

• The study consisted of 18 participants.
• The age range was 5–19 years.
• In group 1, the mean age was 11.7 years (SD ± 4.2). In group 2, the mean age was 12.5 years (SD ±3.6).
• The sample was 50% female and 50% male.
• Cancer diagnoses were acute lymphoblastic leukemia, rhabdomyosarcoma, Ewing sarcoma, medulloblastoma, osteosarcoma, and other diagnoses (not specified).
• The majority of patients (n = 14) were Caucasian, 8 were enrolled in their first chemotherapy course, and 10 were enrolled in their second or later chemotherapy course.
• No patient had used acupressure or acupuncture prior to the study.

The study was conducted in a single inpatient site at a children’s hospital in North Carolina.

All participants were pediatric patients in active treatment.

This was a pilot study. It was a prospective, randomized, crossover clinical trial.

The study used modified methods of Morrow questionnaires. It did not state how the tool was modified. No reliability or validity information was provided.

Questionnaires quantified nausea on an 11-point Likert scale, collected demographics and diagnoses, and measured the following.

• Previous knowledge and experience with acupressure or acupuncture
• Expectations of nausea prevention
• Episodes of emesis
• Presence and degree of nausea
• Side effects
• Satisfaction
• Perceived differences between the acupressure and placebo bands

• Patients somewhat expected the bands to prevent nausea and vomiting. The mean rating of acupressure bands was 6.9 out of 10 and of placebo bands was 5.0 out of 10.
• No difference was found in nausea or number of vomiting episodes among the acupressure band, placebo band, and no band.
• After the bands were worn, many patients reported that their expectations of nausea prevention were met (56% if patients using the acupressure band and 67% of patients using the placebo band) or exceeded (33% of patients using the acupressure band and 28% of patients using the placebo band).
• When no bands were worn, 61% of patients expected more nausea.

Although acupressure bands did not show a reduction in nausea or vomiting, patients perceived the bands as moderately effective, planned to use them in the future, and indicated they would recommend them.

• The sample was small.
• The study did not consider other nausea and vomiting therapy such as antiemetic usage.
• Actual adherence to the wristbands was not reported.
• The reliability of questionnaire use with young children is not clear.

The acupressure bands did not demonstrate a significant change in actual incidence of nausea and vomiting; however, this therapy may be helpful in reducing expectations of CINV.

To evaluate the safety and efficacy of antiemetic medication administration via patient-controlled infusion pump

Patients who failed a standard antiemetic regimen (including a scheduled 5HT3 and one or more additional breakthrough medication of a different class) were placed on a patient-controlled pump containing diphenhydramine 4 mg/ml, lorazepam 0.16 mg/ml, and dexamethasone 0.27 mg/ml mixed in 30 ml of normal saline. The pump ran with a basal rate of 0.1–0.2 ml per hour with a demand dose of 1–2 ml every 30 minutes. The infusion pump was used along with a scheduled 5HT3 agent.

• N = 30  
• MEDIAN AGE = 14.5 years (range = 4–18 years)
• MALES: 47%, FEMALES: 53%
• KEY DISEASE CHARACTERISTICS: Twenty-five patients with solid tumors (sarcoma and neuroblastoma) and five with acute leukemia
• OTHER KEY SAMPLE CHARACTERISTICS: 72% received highly emetogenic chemotherapy and 28% received moderately emetogenic chemotherapy. Dexamethasone was not used in 30% of the cycles for various reasons.

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Nashville, TN

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

This was a quasi-experimental trial with no comparison group. Data were from a retrospective chart review of all patients who used an antiemetic pump to control chemotherapy-induced nausea and vomiting (CINV) between March 1999 and April 2004.

Complete response (CR) was defined as no emesis and no rescue medications. If emesis occurred but no rescue medications were used, it was considered a partial response (PR). Failure was defined as the use of rescue medications. Total patient days in CR, PR, and failure were counted for cycles with and without the antiemetic pump. The total number of rescue medications used and the total number of hospital days also were compared.

Patients with an antiemetic infusion pump had more days in CR than without (45 versus 21 days). A larger number of rescue medications were required to control breakthrough nausea and emesis for the conventional prophylaxis versus the antiemetic pump (108 versus 24). Patients with an antiemetic pump had significantly shorter hospital stays.

Using an antiemetic continuous-infusion pump with demand dosing may reduce the total daily dose of each antiemetic medication used individually. Adverse events occurred in 4% of courses, and all side effects resolved with a decreased rate of infusion. No patients required the discontinuation of an infusion pump.

• Small sample (< 100)
• Baseline sample/group differences of import 
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Retrospective study data; potential for placebo effect of patient-controlled pump

Preliminary data showed that using an antiemetic infusion pump with basal and demand dosing may be an effective way to manage CINV in pediatric patients who fail standard antiemetic therapy. Additional research is needed.

To determine the acceptability and feasibility of HHH-G and the study methods to evaluate its impact on participating men’s skill, self confidence, and self care and to assess the impact of intervention on the participating husbands' ratings of marital quality and depressed mood

HHH-G is a group intervention program with five sessions. Intervention was delivered by two trained educational counselors over five separate 1.5-hour sessions delivered at one week intervals. The five sessions included

• Anchoring yourself to be strong for her
• Listening and not fixing
• Gaining a deeper understanding of her
• Connecting with her
• Putting the pieces together.

Each session included a short group presentation by the education counselors and skill building and efficacy enhancing group exercises. Participants were also provided with spouses' workbooks with session specific activities at home and home assignments that focused on enhancing behavioral capabilities including knowledge and skill. Data were collected at baseline, immediately after the last session, and three months later.

• The sample included 54 couples.
• Couples included women undergoing breast cancer treatment at Princess Margaret Hospital at Toronto and their husbands.
• Mean age of the women was 50.6 years.
• Mean age of the men was 53.1 years.

• Single site
• Inpatient setting      
• Princess Margaret Hospital at Toronto, Canada

Phase of care: active antitumor treatment

A mixed method (one-arm, qualitative, pre-post intervention design) was used.

• Demo/clinical data
• Participation retention and treatment compliance
• Spouse skill checklist
• CASE-S
• CES-D
• Revised Didactic Adjustment Scale (RDAS)
• Mutuality and Interpersonal Sensitivity Scale (MIS)

A moderate to favorable increase in skills was noted as measured by the spouse skill checklist (p < 0.001), including the self care and support subscale (p < 0.001) and the wife support scale (p < 0.003). A significant time effect on self efficacy was measured by CASE-S. No significant changes in depressed mood or marital functioning was noted for the husbands, but a significant reduction in depressed mood (p < 0.003) was noted for the wives.

The feasibility and acceptability of HHH-G were supported. No significant reduction in depression scores were noted for male spouses, which might have been caused by the floor effect because baseline CES-D scores were low in male spouses. A large sample size with a control group woul dneed to be studied to truly examine the effectiveness of this intervention program.

• The study had a small sample size, with fewer than 100 participants.
• There was a risk of bias because there was no control group and no random assignment.
• Findings were not generalizable.

Study demonstrated promising findings on feasibility and reduction in depressed mood for the women with breast cancer. This sounds like a cost-effective approach that could be used by nurses and social workers to improve patient and caregiver outcomes, such as increasing self efficacy and marital functioning.

The interventions included a variety of patient education materials delivered by the following methods.

• General cancer education material (Cancer BACUP, a cancer information and support service for patients in the United Kingdom) specific to the patient's cancer—This material included content about understanding radiation therapy, diet, and cancer-specific information.
• Patient-chosen information selected interactively via computer at the cancer center—The patient was given a choice of six booklets to print from the computer.
• A larger volume of material than in the booklets, not chosen specifically by the patient—This information included 40–47 sections of information.
• Patient-chosen personalized information selected interactively from topics based on the patient’s medical record—These topics included “problem list, treatment lists, or your cancer.”
• A subgroup of participants received anxiety management advice. This information was provided through written materials with self-help advice based on work in cognitive behavioral therapy for anxiety.

Participants were divided into eight groups (three factors, 2 x 2 x 2).

• Group 1: Interactively selected, personalized information, and anxiety management advice (N = 50, t2 N = 48, t3 N = 40)
• Group 2: Interactively selected, personalized information, and no anxiety management advice (N = 50, t2 N = 48, t3 N = 44)
• Group 3: Interactively selected, general information, and anxiety management advice (N = 49, t2 N = 44, t3 N = 35)
• Group 4: Interactively selected, general information, and no anxiety management advice (N = 50, t2 N = 50, t3 N = 49)
• Group 5: Automatically selected, personalized information, and anxiety management advice (N = 50, t2 N = 47, t3 N = 39)
• Group 6: Automatically selected, personalized information, and no anxiety management advice (N = 51, t2 N = 50, t3 N = 44)
• Group 7: Automatically selected, general information, and anxiety management advice (N = 50, t2 N = 49, t3 N = 40)
• Group 8: Automatically selected, general information, and no anxiety management advice (N = 50, t2 N = 48, t3 N = 38)

Measurements were taken at baseline, after intervention, and at three months follow-up.

• Study participants were patients starting radiation therapy.
• A total of 874 patients with cancer were identified through radiation clinic appointments. Of these, 604 patients were recruited to the study, and 270 were excluded.
• Patients were excluded if they were receiving palliative care, had severe symptoms causing distress, had cancer at other sites, did not have English-language skills, were receiving treatment for psychological or psychiatric problems, or were visually or mentally impaired.
• The study reported on a sample of 400 patients with cancer diagnosed from 5 weeks to six years before recruitment.
• Patients completed a questionnaire at home about their previous computer use, information preferences, coping styles, and HSSQ and HADS tests.
• Two-thirds of the patients had breast cancer, and roughly one-third had prostate cancer.
• A total of 348 patients finished follow-up.

Western Scotland

A longitudinal, randomized trial design was used.

• Helgeson’s Social Support Questionnaire (HSSQ)
• Hospital Anxiety and Depression Scale (HADS)
• Questions about the patients’ use and opinions of the booklets and their reported understanding of cancer

At three months follow-up, 45% of patients had improved anxiety scores. There were no statistically significant differences among the three intervention factors using a general linear model.

• The authors concluded that the single information intervention with anxiety management advice in this study did not significantly reduce levels of anxiety.
• This large study showed that brief written anxiety advice does not significantly reduce anxiety in patients with cancer who are starting radiation therapy.

To compare mindfulness-based stress reduction (MBSR) with psychoeducation/support groups (PES) as interventions to treat cancer-related fatigue (CFR) and associated symptoms of anxiety, depression, vitality, sleep disturbances, and pain. An active treatment control group (PES) was used to determine the effect size of MBSR in reducing CRF.

Breast cancer survivors (BCSs) and colorectal cancer survivors (CRCSs) were blinded and randomized into the MBSR group or the PES intervention. The primary outcome was CRF interference, and secondary outcomes of CRF were severity, vitality, anxiety, depression, sleep disturbances, and pain at baseline (T1), postintervention (T2) and at six months postintervention (T3). Both arms of the study included a structured curriculum that lasted two hours weekly for eight weeks. As the MBSR cohort had required exercises and practice assigned between classes, the PES arm was also given between-session practice and supplemental readings related to class topics. Treatment fidelity to each of the interventions was maintained by use of standardized manuals for each (MBSR and PES), audio recordings of the sessions with review by investigators using checklists created to evaluate the interventions. The MBSR intervention was adapted from standard approaches to eliminate the use of a retreat, the addition of psychoeducation, a brief body scan at bedtime, and shorter home practices. The PES program incorporated group discussions.

• N = 69   
• MEAN AGE = BCS: 56.9 years (SD = 9.9 years), CRCS: 56.4 years (12.7 years)
• MALES: 9.9%, FEMALES: 90.1%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Adults aged 18 years or older with nonmetastatic (stage 0–III) BCSs or CRCSs who reported CRF as 4 or greater on the Fatigue Symptom Inventory (FSI)
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had completed active treatment an average of 2.4 years prior to the study and were predominantly Caucasian (70.4%). Forty-six percent of the BCSs were on endocrine therapy at the time of the study, and the only statistically significant difference between groups at baseline was income (p = 0.07).

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: National Cancer Institute–designated comprehensive cancer center clinics

PHASE OF CARE: Late effects and survivorship

Single-blind, two-armed, randomized clinical pilot trail

• FSI
• SF-36 Vitality Scale
• Patient Health Questionnaire-8 (PHQ-8)
• Generalized Anxiety Disorder-7 scale
• Patient Health Questionnaire-9 (PHQ-9) for depression 
• Insomnia Severity Index
• PEG three-item abbreviated version of the Brief Pain Inventory (BPI)
• Global Improvement in Fatigue measure was a single item asking participants to rate their CRF compared to the beginning of the study.

The primary outcome of CRF interference did not significantly differ between MBSR and PES, although a trend (insignificant) toward MBSR was observed at T2 (d = –0.46, p = 0.073). Secondary outcome of vitality demonstrated moderate and significant effect size in the MBSR arm compared to the PES arm (d = 0.53, p = 0.003) at T2; however, the between group difference did not last through the T3 measurement. The MBSR maintained improvement in vitality, whereas vitality improved in the PES group. In addition, at T2, the MBSR participants were significantly more likely to report CRF global improvement (58.8 versus 34.3%, respectively, X² (1) = 4.176, p = 0.041). Both groups continued to report similar global improvements in CRF at T3 (MBSR = 45.5 versus PES = 54.3%, X² (1) = 0.53, p = 0.467). Pain was the only between group secondary outcome in which MBSR demonstrated moderate and significant improvement at T3 compared to PES (d = –0.50, p = 0.014).

Within group effects: Both MBSR and PES participants demonstrated moderate to large effects and significant improvements on all fatigue outcomes at T2 and T3 compared to T1. Participants in both groups also reported moderate to large effects and significant improvements at T2 and T3 from baseline in depression (p < 0.001), anxiety (p < 0.001), and sleep disturbance (p < 0.001).

Although the aim of this study was to rigorously test MBSR as an intervention for CRF in preparation for a phase-III randomized, controlled trial, the study supported the strength of PES as an intervention as well.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (sample characteristics)
• Findings not generalizable

Although MBSR has been shown an effective intervention for numerous cancer-related symptoms, including CRF, a structured PES intervention was also clearly effective in helping survivors manage fatigue and other symptoms. However, given the more immediate effect of MBSR for participants, MBSR may provide results sooner. Both interventions are efficacious and therefore provide cancer survivors a choice in interventions effective in reducing CRF and its interference in daily life through anxiety, depression, and sleep disturbance.