To provide a quantitative, meta-analytic review of the efficacy of mindfulness-based therapy (MBT) for improving anxiety and mood symptoms in clinical populations

• Databases: PubMed, PsycINFO, the Cochrane Library.
• Keywords: mindfulness plus meditation, program, therapy or intervention, anxiety, mood, depression or stress.
• Inclusion criteria: Studies that included a mindfulness-based intervention, a clinical sample, and adults 18–65 years. The mindfulness program was not coupled with treatment using acceptance and commitment therapy or dialectical behavior therapy. Researchers included a measure of anxiety and/or mood symptoms pre- and postintervention, and they provide sufficient data to perform effect-size analyses.
• Exclusion criteria: Studies in which the interventions differed substantially from mindfulness-based stress reduction (MBSR) or mindfulness-based cognitive therapy (MBCT) in length; studies in which the MBT was not delivered in person.

• Method of included-study evaluation: Two authors extracted data and analyzed changes pre- to posttreatment, pretreatment to follow-up, and intent to treat. Evaluation included a modified Jadad assessment of methodological quality. Two independent raters performed the assessment. Inter-rater reliability was r = 0.96.
• The total number of studies reviewed initially was 727.
• The study detailed publication bias and effect size.

• The report evaluated 39 studies. Sixteen of the studies included a control or comparison group.
• Total sample size: 1,140; individual study samples: 8–103. The most common clinical disorder was cancer (n = 9), followed by generalized anxiety disorder (n = 5), depression (n = 4), and 16 other clinical disorders. Many studies targeted more than one disorder.
• The report did not cite sample characteristics.

MBT was moderately effective for improving anxiety (Hedges’s g = 0.63) and mood symptoms (Hedges’s g = 0.59) from pre- to post-treatment in the overall sample. Eight studies met criteria for elevated levels of depression symptoms at pretreatment; none of these involved patients with cancer.

The effects of MBT on depression and anxiety related to chronic conditions, such as cancer, might be smaller than expected, because patients may experience physical symptoms listed on depression or anxiety scales as a result of their physical condition or as a side effect of medical treatment.

• The study does not present information about type, stage, and treatment of cancer. The study does not describe sample characteristics other than adult age.
• Researchers do not describe the specifics of the mindfulness interventions. 
• Researchers used many tools to measure anxiety and depression. Understanding if these tools measured the same things is difficult.
• Clinical populations varied. Many populations had only one study to represent them. Therefore, generalizability is limited.

MBT is a promising intervention in the treatment of anxiety and mood problems in patients with medical diagnoses, including cancer.

To design and test the feasibility and acceptability of a postsurgical intervention with exercise for patients with non-small cell lung cancer to promote perceived self-efficacy for fatigue self-management targeting cancer-related fatigue (CRF) severity and its associated fatigability

Participants performed warm-up exercises designed for the patient population. Wii walking was self-paced and comfortable for participants with the Wii exercise equipment, creating a virtual environment in a town of happy people providing encouragement to continue. Patients started walking five minutes each day for five days during week 1 and increased by five-minute intervals per day until a goal of 30 minutes per day of Wii walking was reached by week 6. The nurse assessed each participant’s readiness to advance the walking prescription. Participants also completed balance exercises five days a week from weeks 1 to 6 from a menu of predetermined Wii balance exercises, which used a gaming format. Data were recorded in the participants' daily diaries and confirmed by research staff as recorded in the Wii Fit Plus.

• N = 72   
• AGE RANGE = 37–89 years
• MEAN AGE = 67 years
• MALES: 44%, FEMALES: 56%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Early to late stage suspected non-small cell lung cancer receiving a surgical intervention
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had to be at least 21 years of age; have a Karnofsky Performance Status of 70% or greater; have medically stable comorbid conditions presurgery; get the approval of a surgeon prior to and after surgery; have phone access; be able to speak and write English; own a television; have no severe sensory impairment that would increase the risks of exercise; have no metastatic disease requiring portable oxygen for activities of daily living; weigh equal to or less than 330 pounds; and have no history of photosensitive seizures or dementia, which would limit safety or full participation.

• SITE: Multi-site   
• SETTING TYPE: Home    
• LOCATION: Michigan

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care

Two-arm, randomized, controlled trial to compare the impact of a six-week rehabilitative CRF self-management exercise intervention post-surgical hospital discharge. The control group used a Wii-based walking and balance home program at home.

Feasibility: Rates of recruitment, adherence, retention, and monitoring of adverse events

Acceptability: 15-item acceptability questionnaire developed by the researchers

Efficacy:

• Brief Fatigue Inventory (BFI)
• Perceived Self-Efficacy for Fatigue Self-Management
• Perceived Self-Eefficacy for Walking Duration
• Activities-Specific Balance Confidence Scale
• Cancer-related fatigue self-management behaviors diary

Functional status:

• Capacity-fatigability six-minute walk test (6MWT) (fatigue reported during the 6MWT and distance walked in six minutes)
• Performance: Modified Borg Scale (fatigue severity during the 6MWT) and Medical Outcomes Study Short Form 36, version 2, Acute Recall
• Demographic questionnaire
• Modified version of the Comorbidity Questionnaire
• Smoking-Behavioral Risk Factor Survey
• Karnofsky Performance Status Score

Feasibility and acceptability: Recruitment, vulnerable population, adherence, and acceptability goals were exceeded. No adverse events were reported.

Efficacy: At week 6, interval scores for CRF, CRF self-management, walking, balance, and fatigability were significantly different (p < 0.001) between the intervention group and control group. Participants exceeded minimum walking-balance exercise behaviors during the six-week study period. Functional performance decreased postsurgery in both the control and intervention groups. Improvement occurred in weeks 1–6 for both groups but improved more slowly in the control group versus the intervention group.

A home- and Wii-based exercise and balance program for patients with lung cancer postsurgery is a feasible, acceptable, safe, and effective method to improve fatigue and fatigability in this patient population.

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

Early rehabilitation exercise and balance interventions for patients undergoing surgery for non-small cell lung cancer are feasible, acceptable, and safe. Additional research is needed to determine factors to enhance adherence to exercise and balance interventions beyond the immediate postsurgical period (six weeks) and to determine their effects on prognosis and functional (physical and mental) capacity.

To explore the efficacy of a virtual reality home-based exercise program for managing fatigue during adjuvant therapy in patients with postthoracotomy lung cancer.

Patients were initially provided self-management education for fatigue and a Nintendo Wii system for walking and balance exercise in the home. Nurses initiated the program in a home visit, performed follow-up at two weeks, and contacted patients via telephone for reinforcement at three and six weeks in the initial study. This report involved extension of the initial study for an additional 10 weeks while patients were receiving adjuvant therapy. Patients wore a pedometer to record the number of steps per day and were to use the program five days per week.

• Seven participants (28.6% male, 71.4% female) were included in the study.
• Mean age was 64.4 years (range 53–73).
• All participants were postthoracotomy for non-small cell lung cancer. 
• Five patients began chemotherapy at five weeks postsurgery.

• Multisite 
• Home 
• Michigan

Patients were undergoing the active antitumor treatment phase of care.

This was a prospective trial.

• Acceptability questionnaire
• Brief Fatigue Inventory (BFI)
• Fatigue Self-Management Instrument
• Self-efficacy for walking instrument
• Walking duration instruments
• Activities-Specific Balance Confidence (ABC) scale
• Daily diary to record fatigue and exercise use

Adherence to the exercise protocol declined slightly from the previous six-week study to an overall adherence of 87.6% (range 59%–100%). All patients reported unmanaged symptoms unrelated to the exercise at some point in the 10 weeks. Fatigue scores increased slightly from weeks 6 to 14 and then declined further. Self-efficacy for walking and self-management were relatively stable. There was high variability in the average walking steps per day from the pedometers.

Results suggested continued feasibility and overall efficacy of the virtual reality home-based exercise and balance program tested. Findings showed that, over longer periods of time, program adherence declined and was more variable. Some of this variability in exercise adherence and fatigue scores may be associated with periods of adjuvant chemotherapy and radiation therapy.

• The study had a small sample size, with less than 30 participants.
• The study had risks of bias due to no control group, no blinding, no random assignment, and no appropriate attentional control condition.
• The intervention was expensive, impractical, or had training needs.
• The Nintendo Wii system had associated costs.

The use of a home virtual reality–based approach to facilitate exercise among patients with cancer is a promising approach for self-management of fatigue.  Larger well-designed research using this approach is warranted.

To evaluate the feasibility, safety, acceptability, and effects of a home-based exercise intervention.

Patients were screened for inclusion, and baseline measures were obtained prior to surgery. Each patient was assigned a primary nurse for the duration of the study to ensure continuity of care. Prior to surgery, participants were taught approaches to increase self-efficacy in self-management of fatigue and were prepared to participate in the exercise intervention after surgery. Within three days of hospital discharge, patients were contacted by telephone and screened for readiness to start exercise. When ready, a home visit was scheduled to set up the exercise equipment (the Nintendo Wii Fit Plus), the particpant was educated in the exercise intervention, and teaching for self-management was reinforced. The exercise intervention provided a virtual reality scenario for walking. After week 2, another home visit was performed, and telephone contacts were made at three and six weeks. Patients completed study tools at the end of six weeks via mail.

• Seven participants (28.6% male, 71.4% female) were included.
• Mean age was 64.4 years (range 53–73).
• All participants had lung cancer and were postthoracotomy.  
• Most participans were employed and had no children living at home. 
• Comorbid conditions included osteoarthritis, hypertension, and chronic obstructive pulmonary disease.  
• Some patients started chemotherapy and/or radiation therapy within the study period.

• Multisite 
• Home 
• Michigan

Patients were undergoing the active antitumor treatment phase of care.

This was a prospective, single-group, feasibility trial.

• Acceptability questionnaire
• Brief Fatigue Inventory (BFI)
• Fatigue Self-Management Instrument
• Self-efficacy for walking instrument
• Walking duration instruments
• Activities-Specific Balance Confidence (ABC) scale
• Daily diary to record fatigue and exercise use

Mean adherence to the exercise intervention was 96.6% (range 90%–100%). Participants reported a high level of satisfaction with the exercise intervention.  Overall decline in fatigue was seen from postsurgery to the end of the study. All participants stated that the intervention helped them to manage their fatigue. Fifty percent of those approached for participation consented and completed the study.

Use of the Nintendo Wii Fit Plus sytem for a home-based exercise intervention was shown to be feasible and effective in helping patients self-manage fatigue in this small study.

• The study had a small sample size, with less than 30 participants.
• The study had risks of bias due to no control group, no blinding, no random assignment, and no appropriate attentional control condition.
• Measurements/methods were not described.
• The intervention was expensive, impractical, and had training needs.
• Tools used in the study were not well described. 
• The Nintendo Wii Fit Plus system has associated costs that would need to be met.

Findings suggested that use of home virtual reality exercise programs, such as the Nintendo Wii Fit Plus system, can be a feasible and effective way to promote exercise for the self-management of cancer-related fatigue.

To describe the effects of a postsurgical home exercise intervention implemented immediately after hospital discharge on cancer-related fatigue (CRF), other symptoms, functional status, and quality of life (QOL) in individuals with non-small cell lung cancer (NSCLC)

Patient education in a hospital regarding exercise was followed by a home visit from a nurse educated on warm-up exercises, light intensity exercise such as walking, and balance exercises with a Wii. Patients were instructed to increase walking to goal of 30 minutes a day in week 6.

• N = 7  
• MEAN AGE = 64.6 years (range = 53–73 years)
• MALES: 29%, FEMALES: 71%
• KEY DISEASE CHARACTERISTICS: All received lobectomy for NSCLC; average of 5.9 comorbidities
• OTHER KEY SAMPLE CHARACTERISTICS: Five of seven patients started chemotherapy in week 5.

• SITE: Single site    
• SETTING TYPE: Home    
• LOCATION: University teaching hospital in Michigan

• PHASE OF CARE: Active antitumor treatment

Pilot study

• Brief Fatigue Inventory (BFI)
• MD Anderson Symptom Inventory (MDASI) core and lung module (symptom severity)
• Medical Outcomes Short Form-36 (MO SF-36 v.2) acute recall (function)
• Ferrans and Powers Quality of Life Index (FP QLI) (QOL)

• Fatigue: Presurgery = 3.5, postsurgery = 4.8, and week 6 = 2.8
• Overall physical function: Presurgery = 49.8, postsurgery = 31.5, and week 6 = 45.9
• QOL: Presurgery = 23.5, postsurgery = 22.4, and week 6 = 23.8

Cancer-related fatigue decreased below presurgery levels after six weeks of exercise intervention.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition) 

Home-based exercise may reduce cancer-related fatigue in patients with NSCLC postsurgery.

• To assess the effectiveness of a mindfulness-based stress reduction (MBSR) intervention for mood, breast- and endocrine-specific quality of life, and well-being after hospital treatment in women with stage 0 to III breast cancer.
• To compare MBSR to usual care and its effect on mood and disease-related quality of life.
• To measure if a dose-related effect was evident with formal, eight-week MBSR practice.

The intervention consisted of an eight-week MBSR program closely following the Kabat-Zinn method. The intervention involved 2- to 2.25-hour classes and a 6-hour retreat. Home practice was recommended for 45 minutes, six to seven days per week. Outcomes were measured at baseline, weeks 8 to 12, and weeks 12 to 14. A wait-list control group received usual care.

• A total of 229 patients (100% female) participated.
• Mean age was 49 years (SD = 9.26 years) in the treatment group and 50.1 years (SD = 9.14 years) in the control group.
• Patients had been diagnosed with stage 0 to III breast cancer; 47% had stage II cancer.
• Participants were recruited from The Haven, a charitable day center that provides free psychosocial services for patients with breast cancer. All patients had received an average of 30 hours of support prior to entering the study.

• Single site
• Outpatient
• The Haven, London, England

• Patients were undergoing long-term follow-up.
• The study has clinical applicability for late effects and survivorship.

The study used a randomized, controlled trial design.

• Profile of Mood States (POMS) questionnaire
• Functional Assessment of Cancer Therapy (FACT)–Breast and Endocrine Symptoms 
• World Health Organization (WHO) (Five) Well-being Index

• The study revealed significant differences between the groups in regard to POMS subscale scores (p < 0.001): depression (p = 0.017), anxiety (p < 0.001), anger (p = 0.005), vigor (p < 0.001), fatigue (p = 0.002), and confusion (p = 0.002).
• Participants completed a mean of 19.58 hours (standard deviation = 11.49 hours) of home MBSR practice over eight weeks, or 21 minutes per day. Increased hours of MBSR practice improved POMS scores at T3 for overall mood (p = 0.004), vigor (p = 0.02), fatigue (p = 0.03), and anxiety (p = 0.01). POMS scores improved at T2 and T3 for anger (p = 0.005 and 0.02, respectively), confusion (p = 0.04 and 0.001, respectively), and well-being.

MBSR significantly improved mood and reduced confusion.

• The study lacked an appropriate control group.
• The control group was not attention controlled, which limited the interpretation of between-group differences.
• The setting was unique, and the intervention used many resources, which made implementing and generalizing findings difficult.
• The study had a risk of bias due to lack of blinding.

Although further study is needed to measure MBSR and its impact on depression and anxiety, in this sample, home-based practice was feasible and improved mood. In practice and education, nurses can promote components of MBSR, such as breathing, yoga, relaxation, meditation, seeking support resources, and gentle stretching.

To evaluate the efficacy and safety of long-acting release (LAR) octreotide for the prevention of chemotherapy-induced diarrhea (CID)

This prospective, randomized clinical trial compared the administration of octreotide LAR 30 mg IM every four weeks beginning with first-cycle to the administration of a physician’s choice of medication in a group of patients with colorectal cancer starting adjuvant or first-line treatment. Patients received combination chemotherapy with fluorouracil, capecitabine, and/or irinotecan. Treatment with octreotide LAR was continued for six months or until chemotherapy discontinued or until the patient developed unacceptable toxicity related to the study drug (whichever occurred first). The choice for the treatment for diarrhea for both arms was at the physicians' discretion, but the control group could not receive octreotide LAR. Patients were stratified according to the use of irinotecan.

• N = 139  
• AGE RANGE = 22–78 years
• MALES: Treatment group 45.6%; control group 42.3%, FEMALES: Treatment group 54.4%; control group 57.7%
• KEY DISEASE CHARACTERISTICS: Patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan.
• OTHER KEY SAMPLE CHARACTERISTICS: Sites of metastatic disease, colostomy, and type of surgery

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Brazil at multiple institutions

• PHASE OF CARE: Active antitumor treatment

Randomized, multi-centered, open-labeled, phase III trial

• To evaluate the incidence and severity of diarrhea, a patient diary was given to patients at each visit, and the completed tool was collected at the next visit. The diary was used to record patient events. 
• All adverse events (related to laboratory or dose reductions) were collected through medical records.
• A Functional Assessment of Chronic Illness Therapy For Patients With Diarrhea (FACIT-D) scale was collected at each visit. 

139 patients were randomly assigned. Most received a fluorouracil (treatment  98.5%, control  98.6%) or oxaliplatin (treatment 76.5%, control 63.4%) containing regimen. The rate of diarrhea was 76.1% in the treatment group (n = 68) and 78.9% in the control group (n = 71). Treatment with octreotide LAR did not prevent or reduce the severity of chemotherapy-induced diarrhea.

There was no benefit in using octreotide LAR prophylactic in patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan.

• Risk of bias (no blinding)
• There was a small number of patients who received chemotherapy with other regimens containing irinotecan. There was also the smaller proportion of patients presenting with grade 3 or 4 diarrhea. 

There was no benefit in using octreotide LAR prophylactic in patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan. This has also been evaluated in other studies that have looked at octreotide LAR using escalation doses of 30 or 40 mg, and the results were similar. Per the authors of this study, the short-acting octreotide remains the formulation of choice in the treatment of CID.

The intervention was a formal education/orientation program with oral and written information for patients and their significant others upon beginning radiation therapy. The control group of patients receiving radiation therapy and their significant others received information during their consultation visit via the physician, several pamphlets, and individual teaching by the nurse.

• The study reported on a sample of 100 people (the patient and his or her significant other counted as two people).
• A total of 85 people completed the postintervention assessment: 49 in the intervention group and 36 in the control group.
• All diagnoses and all stages of cancer were included.
• All participants were new to radiation therapy.

A randomized controlled trial design was used.

• State-Trait Anxiety Inventory (STAI)Form Y–State anxiety subscale
• 20-item self-report index
• Profile of Mood States (POMS)–Total Mood Disturbance measure
• 10-item multiple choice test developed for study to measure radiation knowledge

The information orientation session had no significant effect on anxiety, general distress, adherence to treatment, or knowledge about radiation. The program did increase satisfaction with care, use of psychological counseling, and outside support resources.

• The study had a small sample size.
• The study did not report baseline measurements or screening of anxiety prior to intervention.

To investigate the use of extra-orally applied near infrared phototherapy for the reduction of oral pain secondary to chemotherapy and radiation therapy induced mucositis in adult and pediatric HSCT patients.  

Eighty HSCT patients were divided into regular and low risk groups, and then into experimental and placebo groups. The experimental groups received gallium-aluminum-arsinide light emitting diode (LED) once daily, while the placebo group also received a similar appearing placebo treatment daily, beginning on day of HSCT (day 0) through day 14. The LED was applied extra-orally, by placing the light source in contact with the cheeks and anterior throat. The blinded evaluators examined the patients three times/week scoring their oral tissues, and patient reported pain assessments.

The sample was comprised of 80 patients age 3-74 years.

Males (%): 55 and Females (%): 45

Key Disease Characteristics: Aplastic anemia, neuroblastoma, AML, NHL, CLL, SLL, ALL, Hodkin’s disease, PNT, MES, Ewing's sarcoma, sickle cell anemia, CML, TC, HLH, WAS, MDS, osteoporosis, lymphoma, multiple myeloma, POEMS, amyloidosis

Other Key Sample Characteristics: All patients received conditioning therapy with melphalan.

Site: Multi-site

Setting Type: Not specified

Location: Children’s Hospital of Wisconsin, University of Alabama - Birmingham, The Children’s Hospital of Alabama

Phase of Care: Active treatment

Randomized, double-blinded, placebo-controlled

• WHO pain assessment scale
• NCICT GI Criteria for Adverse Events
• OMAS erythema or ulceration scale
• Patient diary form with questions concerning mouth pain -  ADULT - VAS (no pain and most severe pain possible) PEDIATRICS - Wong Baker FACES pain scale
• Patient diary using the same scales adapted to measure the impact on swallowing from no trouble to unable to swallow anything (including saliva)
• Patient report regarding eating normally; eat only soft solid foods; consume only liquids; or could not tolerate any food or liquids.
   

There were no significant differences in the WHO clinical examination scale between any of the groups. The other scales used also did not elicit significant differences.

Although it was not statistically significant, the data suggested a trend for the experimental groups to have general improvements in all of the scales.

Small sample <100

Groups were not split into children versus adults.

Inconclusive, would need much more research to demonstrate effectiveness. The positive note was that this treatment is applied extra-orally, making it more tolerable during periods of oral mucositis. This treatment would require education for the healthcare team as well as added cost for the use of the technology.

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Palliative care

Per the authors, evidence exists to support olanzapine in highly emetogenic regimens. The Navari (2011) trial was the strongest study to support the use of olanzapine. Toxicity in all included trials demonstrated little side effects. Only one trial described sleepiness during chemotherapy. Olanzapine is a safe and more costly option to use instead of NK-1 antagonists. When used with other antiemetics such as metoclopramide there is a role in prevention, and as a single agent it shows efficacy in delayed CINV as well.

There were only three studies in each group. Only the Shumway trial was double-blinded, but it was a small trial. All the breakthrough trials were by the same investigator and included less than 110 patients.

Olanzapine may have a role in preventing CINV and delayed CINV but there is still limited research. The most recent trial for delayed CINV is a small trial but is double-blinded. Further research is indicated.