To examine the effect of an eight-week Mindfulness-Based Stress Reduction (MBSR) program compared to an eight-week education and support (ES) program on subjectively and objectively assessed cognitive function among breast and colorectal survivors experiencing fatigue

• N = 69  
• AGE = 56.9 years
• MALES: 9.9%, FEMALES: 90.1%
• KEY DISEASE CHARACTERISTICS: Causasian (70.4%), not college educated (56.3%), employed (52.1%), married or partnered (54.9%), self-reported “comfortable income level” (52.1%)
• OTHER KEY SAMPLE CHARACTERISTICS: Cancer type: Breast (MBSR 51.7%), (ES 48.3%), CRC MBSR (36.4%), (ES 63.6%). Average years since treatment completed was 2.4 years. Any individual reporting experience with meditation was excluded from the sample. Over 50% did not have more than a high school education.

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: Midwestern National Cancer Institute–designated cancer center and affiliate clinics

PHASE OF CARE: Late effects and survivorship

Two-arm, randomized, clinical trial, pilot study

This pilot study demonstrated that MBSR offers significant and sustained improvements in both subjectively and objectively measured chemotherapy-related cognitive impairment. The findings indicated that the MBSR intervention addressed issues of executive function and attentional control in breast and colorectal survivors reporting cancer-related fatigue and cognitive impairment.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Fatigue levels were used as a proxy for the presence of chemotherapy-related cognitive impairment in the selection of sample. The presence of chemotherapy-related cognitive impairment was assessed at baseline after selection of the study sample, and, at that time, a \"large majority of participants reported cognitive impairment as measured by the baseline AFI.\"

The findings of this study suggest that MBSR may improve late effect cognitive/emotional fatigue and cognitive impairment in patients with cancer. As no identified adverse effects of MBSR training or mindfulness meditation exist, this low-risk intervention may be beneficial for patients.

To evaluate the safety, tolerability, and efficacy of linaclotide in patients with chronic constipation.

Patients recorded data related to daily bowel habits and called into a voice response system daily to record their medications taken and bowel movements. Patients were randomized to receive 100, 300, or 1,000 mcg of linaclotide or placebo once daily in the morning, in the fasting state.

• The study reported on a sample of 36 patients.
• Mean patient age was 45.2 years (SD = 12.17).
• The sample comprised 88% women and 12% men.
• Diagnosis-specific information was not provided.
• Patients were excluded if they had pelvic floor dysfunction.
• All patients had experienced constipation for 12 or more weeks within the past year.

• Multi-site
• Outpatient
• United States

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

• Bristol Stool Form Scale
• Ease of Passage Scale
• Subjective patient-reported outcomes of discomfort and overall relief on seven-point Likert-type scales
• National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

• All doses of linaclotide produced a three-fold greater increase in number of spontaneous bowel movements compared to placebo (p = 0.047).
• Weekly stool frequency increased in a dose-related manner.
• Stool consistency improved in all dose groups in a dose-related manner compared to placebo (p < 0.01).
• Patient-reported outcomes improved with all doses of linaclotide, but were not statistically different than those seen with placebo.
• No severe adverse events were reported. The most common adverse event was diarrhea.

Linaclotide appeared to improve symptoms of chronic constipation and was well-tolerated overall.

• The sample size was small (fewer than 100).
• The study was likely underpowered.

The usefulness of linaclotide for patients with cancer who have constipation is not yet known. This medication is a peptide that binds to specific receptors on the membrane of intestinal enterocytes and may increase efflux into the intestinal lumen with concomitant fluid secretion. Those effects may improve stool consistency and transit time. Nurses should be aware that a variety of new medications aimed at management of constipation with various mechanisms of action are being developed. Applicability to patients with cancer has not yet been studied.

This small pilot study had two objectives:  (1) to design a strategy for recruitment tailored to the institutional environment and therapeutic intervention and (2) to collect evidence of preliminary effects.

In a two-part intervention, patients were first taught to improve self-care with regard to exercise, nutrition, and cognitive-behavioral techniques over a four-week period. They were then provided with eight weekly 50-minute acupuncture sessions. This therapeutic protocol references a conceptual framework derived from two theories—Social Cognitive Theory and Integrative Medicine Theory—but did not provide a description of the theory to match the interventions (exercise, nutrition, cognitive therapy, or acupuncture) with conceptual variables in the model.

• The sample was comprised of 13 women with breast cancer.   
• Mean age was 54 years (range 18–65). 
• About two-thirds of the patients were white.

• Single site  
• University of California Los Angeles Center for East-West Medicine
   

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

This was a randomized, controlled feasibility study.

• Brief Fatigue Inventory (BFI) to assess cancer-related fatigue (self-reported)
• Functional Assessment of Cancer Therapy–Cognitive Function, version 2 (FACT-COGv2) to measure three dimensions of perceived cognitive impairment:  cognitive problems, impact on functioning, and impact on health-related quality of life (self-assessment without objective measures)

Failure of the recruitment methods led to the development of a tailored recruitment strategy. The intervention was said to be associated with a 2.38-point decline in fatigue (BFI) (90% confidence interval [0.586, 5.014]; p < 0.10). Differences in perceived cognitive dysfunction outcomes were not statistically significant between the two groups over time. The authors talked about using a pooled standard deviation for the BFI at baseline to compare the means of the two groups to determine the effect size.

An effective recruitment strategy is necessary for the execution of any randomized, controlled trial. The conceptual framework integrating social cognitive theory and integrative medicine was not effectively operationalized.

• The pooled standard deviation was not reported. It was unclear how the Cohen’s D metric was applied to this small study.
• The study had a small sample size, with less than 30 patients; 13 patients were randomized of 40 recruited.
• The study had a poor design.
• Numerous confounding variables were not controlled for in the first part of the intervention in which patients were taught to improve self-care by optimizing exercise routines, improving nutrition, and implementing various cognitive-behavioral techniques.
• The tailored recruitment strategy of two two-hour recruitment sessions is labor intensive to yield only 5 interested patients.
• One patient assigned to the control group actually received acupuncture and patient education, but his/her results were calculated with the control group.
• The study was nonblinded.

Investigation into outcomes attributed to specific patient education interventions might first be warranted before blending such an educational intervention with a complimentary/alternative therapy studying efficacy on cancer-related fatigue.

To review the use of corticosteroids and infliximab in the treatment of patients with immune-mediated colitis secondary to anti-CTLA-4 antibody treatment

Five patients in a phase III trial for malignant melanoma treatment who developed diarrhea after receiving anti-CTLA-4 antibody treatment were evaluated. Four patients received tremelimumab, and one received ipilimumab. All five patients presented with acute diarrhea within a median of 35 days (range 10–53) after the last anti-CTLA-4 dose. Diarrhea was defined as loose or watery, nonbloody, and occurring four to eight times daily. Laboratory results were benign, and infection diarrhea was ruled out. Each patient underwent flexible sigmoidoscopy that revealed edema, erythema, ulcerations, and fibrinopurulent exudates. All five patients were treated with high-dose corticosteroids (prednisone 40–60 mg by mouth daily) for one week. Patients with continued, relapsed, or partial response beyond one week of treatment were treated with infliximab 5 mg/kg.

• N = 5   
• AGE = 50–78 years
• MALES: 2, FEMALES: 3
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Malignant melanoma
• OTHER KEY SAMPLE CHARACTERISTICS: No previous history of unexplained diarrhea or inflammatory bowel disease, acute diarrhea after receiving anti-CTLA-4

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Miami, FL

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care 

Prospective, observational trial

Case series report

Treatment with infliximab resulted in a resolution of symptoms within two to three days in all patients. Resolution was defined as a return to baseline bowel habits of one to two solid bowel movements per day. One patient had recurrence of symptoms within three weeks and was given a second treatment with infliximab with success. All patients had a four- to six-week follow-up to ensure resolution. None had a repeat sigmoidoscopy. The authors concluded that, to their knowledge, no untoward side effects to inflixamab have occurred, including infection. The discussion refers to this regimen as based on one article (Beck et al.). The discussion also raises concerning issues about the affect of infliximab on tumor response. The current authors further state that the drug could affect other immune suppressant properties, predisposing patients to serious infection and cancer progression.

Infliximab was effective in resolving immunotherapy-related diarrhea in this small group of patients.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Selective outcomes reporting
• Measurement/methods not well described
• Findings not generalizable

Anti-CTLA-4 antibody treatment can cause immune-mediated colitis. Nurses must be knowledgeable about advances in the treatment of immune-related adverse reactions, such as colitis.

PHASE OF CARE: Multiple phases of care

CBT-I resulted in a significant improvement on sleep efficiency relative to control from pre- to postintervention (p < 0.01), with a medium effect size pooled across studies (0.53, 95% CI [0.39; 0.68]); and improvement at six-month follow-up (p < 0.01), with effect size (0.33,  95% CI [0.11, 0.54]). There were significant improvement on sleep onset latency relative to control from pre- to postintervention (p < 0.01), with a small to medium effect size pooled across studies (0.43, 95% CI [0.27, 0.58]); and it persisted at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). And, finally, there were significant improvements on wake after sleep onset from pre- to post-intervention (p < 0.01), with a small to medium effect size pooled across studies (0.41, 95% CI [0.24, 0.59]) persisting at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). Overall, there were statistically significant improvements in insomnia severity following CBT-I relative to control from pre- to postintervention (p < 0.01), with a large effect size pooled across studies (0.77, 95% CI [0.6, 0.93]). Four RCTs reported data on insomnia severity at six months (p < 0.01), with effect size pooled across studies (0.54, 95% CI [0.37, 0.73]).

The results of the meta-analysis indicate that survivors of cancer treated with CBT-I showed improvements in sleep efficiency, sleep onset latency, and wake after sleep onset as measured by sleep diaries, and insomnia symptom severity as measured by the ISI when compared to the usual care, waitlist control, or active comparator conditions. In addition, the observed effects persisted at six-month follow-up, suggesting that CBT-I provides significant, lasting improvements in sleep. Future research should examine the mechanisms by which CBT-I improves sleep in the cancer population. And specifically, the relative impact of behavioral versus cognitive change is unclear.

It was not possible to directly compare the efficacy of CBT-I as delivered either individually, in a group, online, or via video. Majority of included trials were conducted in women with stage I-III breast cancer, and it is unclear how well the observed results will generalize across the cancer continuum.

Individuals diagnosed with cancer are particularly vulnerable to insomnia with a prevalence rate almost twice that of the general population (50%–60% versus 12%–25%). CBT-I was effective across diverse treatment modalities, intervention lengths, and cancer diagnoses or stages in improving sleep diary outcomes that were durable at six months.

To investigate the effectiveness of integrative medicine therapies on pain and anxiety among patients with cancer

The integrative medicine (IM) therapies included in this study were in three different categories, (a) bodywork, which included craniosacral therapy, medical massage, and reflexology, (b) mind-body and energy (MBE) therapies, which were further divided into separate categories, and (c) traditional Chinese medicine, which included acupressure, acupuncture, and Korean hand therapy. Patients could receive therapy from one category or from more than one in combination therapy.

• N = 1,833  
• MEDIAN AGE = 59 years (range = 44–74 years)
• MALES: 35.8%, FEMALES: 64.2%
• KEY DISEASE CHARACTERISTICS: Primary malignancy sites included female breast, bronchus, lung, trachea, colorectal area, hematopoietic or lymph area, and prostate. Patients with all other primary malignancies who were not included in any of these categories were grouped together into an “other” cancer site designation.

• SITE: Single site
• SETTING TYPE: Inpatient hospital
• LOCATION: Midwest United States

• PHASE OF CARE: Acute, chronic, and palliative  
• APPLICATIONS: Elder care and palliative care 

This retrospective, observational study collected data from electronic medical records.

• Pain and anxiety scores were taken by practitioners directly before and after each session using an 11-point scale on which 0 indicated no pain and 10 the worst pain imaginable.

The results of this study indicated that IM therapies need more extensive research to validate findings, suggesting a correlation between improved self-reported pain and anxiety scores and use of these therapies alone or in combination.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Nurses in the oncology inpatient and outpatient settings are instrumental in research evaluating pain management techniques such as IM therapies. Nurses conduct, lead, and participate in every aspect of these studies evaluating patient outcomes from pain management interventions for patients with cancer. Observational studies and qualitative research will be instrumental in developing future evidence-based guidelines.

To evaluate the effect of methylphenidate on fatigue in women with recurrent gynecologic cancer.

Women with recurrent gynecologic cancer currently receiving chemotherapy and reporting fatigue at baseline were prescribed methylphenidate. The dose started at 5 mg taken at 8 am and noon and was titrated up to 10 mg at two weeks if the patient reported a limited response. Data were obtained at baseline and two, four, and eight weeks.

• In total, 13 women were included. 
• Average age was 59 years (range 23–87).
• All patients had recurrent gynecologic cancer:  ovary (n = 25), endometrial (n = 1), cervical (n = 1), vaginal (n = 1), sex cord endometrial (n = 1), ovary and endometrial (n = 1), and unknown histology (n = 2).
• Patients were Caucasian (n = 29), Native American (n = 1), African American  (n = 1), and unknown (n = 1); no other demographic was information available.

• Single site   
• Outpatient   
• Comprehensive cancer center in the United States; University of Oklahoma

Patients were undergoing the active treatment on chemotherapy phase of care.

The study was a prospective trial.

• Fatigue Symptom Inventory (FSI) 
• Functional Assessment of Cancer Treatment–General (FACT-G)
• Brief Symptom Inventory (BSI)

Thirty-two women were initially enrolled; only 13 completed the eight-week follow-up. Scores on the FSI decreased statistically significantly from baseline at all measurement points (week 2, p = 0.0088; week 3, p = 0.0007; week 3, p = 0.0001). BSI scores also decreased, with scores at weeks 4 and 8 significantly lower than baseline (p = 0.015 and 0.0015, respectively). There was an overall change in FACT-G scores over time (p = 0.0351), with significant change in physical well-being (p = 0.0235) and emotional well-being (p = 0.0099). There was no change in family/social and functional well-being.

Methylphenidate may be beneficial to women with recurrent gynecologic cancer experiencing treatment-related fatigue.

• The study had a small sample size, with less than 100 patients.
• The study lacked a control group.
• There was significant attrition.
• The group was very select (recurrent gynecologic cancer).
• There was one treatment site in one country.
• The study lacked racial/ethnic diversity.

Findings suggest that methylphenidate may be beneficial in this small select type of patients. No adverse drug information was formally collected (the authors reported several patients withdrew from the study due to blurred vision, confusion, and dizziness but did not address whether these might be drug- or disease-related); thus, nurses would need to monitor patients closely who receive these drugs.

To assess the effectiveness, after two months, of celiac plexus block (CPB) versus thoracoscopic splanchnicectomy (TS) in patients receiving appropriate medical management (MM) for the pain of pancreatic and other abdominal malignancies

Patients were randomized to one of three treatment groups (MM, MM+CPB, or MM+TS) in blocks of three, stratified by treatment center, tumor type, and current opioid status (opioid naive, not taking strong opioids or started strong opioids within three days before recruitment, or taking strong opioids for more than three days prior to recruitment). Clinical assessments and data collection occurred at randomization, at weeks 2 and 4, and then monthly. Local researchers were not blinded to procedure. Patients completed a daily diary for two months and completed questionnaires at follow-up visits. Oral modified-release morphine was prescribed according to standard practice in each setting and increased 30%–50% as needed for pain control. Rescue medication for breakthrough pain was immediate-release oral morphine. Adjuvant analgesic agents—including amitriptyline, valproate, or gabapentin—were also used as needed for neuropathic pain. NSAIDs or dexamethasone was used for liver capsule pain. Opioid switching occurred as needed to avoid side effects or because of a patient's inability to take oral medications. Opioid rotation was not used. Patients maintained a daily diary of pain assessment.

• Of the 65 patients recruited, 47 completed the study. Authors analyzed data based on intention to treat. In the MM group were 24 patients; in the MM+CPB, 20 patients; in the MM+TS, 21 patients.
• Mean patient age in the MM group was 65.5 years; in the MM+CPB group, 60.5 years; in the MM+TS group, 60.2 years. The age range in all groups was 46–81 years.
• Of all patients, 50.8% were female and 49.2% were male.
• Patients had a confirmed unresectable malignancy of the pancreas or upper abdominal viscera and required opioid analgesia or they had pancreatic or gastric cancer before they had pain. Of the 65 patients recruited, 57 had pancreatic cancer, three had gallbladder cancer, one had bile duct cancer, one had duodenal cancer, and three had unknown malignancies.
• Patients were excluded from the study if they had had previous thoracic surgery or a history of tuberculosis or another intrathoracic inflammatory condition likely to cause extensive adhesions, if they were unfit for general anesthesia, or if they had a life expectancy of less than one month.

• Multisite
• Outpatient
• United Kingdom

Open randomized comparison

• Reduced version of the short form Brief Pain Inventory (BPI)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Core Module
• Adverse-event assessment by clinicians
• Opioid consumption
• Four-point Likert scale for pain assessment (assessments recorded in daily diary)

Pain relief was achieved in one third of patients at two weeks and in just under half of all patients at two months. Researchers observed no differences between groups in pain scores or total opioid consumption at any time point. Two months after randomization, 73% of subjects were taking opioids. Four serious adverse events occurred in three patients: One patient in the MM group was hospitalized for confusion eventually thought to be unrelated to the study medication, one patient was hospitalized for wound infection after TS, and one patient in the TS group had intraoperative bleeding that was resolved with sutures. Of all participants, 53% took opioids regularly during the study and 11.8% took adjuvant analgesics. Worst pain and average pain declined somewhat in all groups.

Authors reported no significant intergroup differences in pain scores or opioid consumption and no correlation between continued use of opioids and effective pain relief. The absence of any benefit from interventions led researchers to question the value of the interventions.

• The study had a small sample size, with fewer than 100 participants.
• Due to slow recruitment and poor pain responses, researchers elected to discontinue the study. Even in the MM group, one fourth of patients had stopped taking opioids at the two-month interval but reported no significant difference in pain control.
• This study did not assess the psychological and social effects of pain. This may have had an impact on pain reporting.
• Authors expressed concern about the possibility of the open design of the study influencing patients' perceptions of pain and patients' expectations regarding the treatment arm to which they were randomized.
• Authors did not report actual statistical results.
• The study was underpowered to detect differences.
• Authors did not report actual opioid doses or data regarding use of rescue medications.

The study presents insufficient evidence to support the efficacy of one treatment over the others.

To compare the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract to the efficacy of placebo in relieving the pain of patients with advanced cancer; to compare the safety and tolerability of the treatments with those of placebo

Patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, were randomized to THC:CBD extract (n = 60 patients), THC extract (n = 58), or placebo (n = 59) for a two-week, multicenter randomized double-blind, placebo-controlled trial.

• The sample was composed of 177 patients.
• Mean patient age was 60.2 years.
• Of all patients, 82 were female and 95 were male.
• In the sample, the primary cancer sites were breast (29), prostate (24), and lung (20). In the sample, pain classifications included mixed pain (89), bone pain (65), neuropathic (39), visceral (37), and somatic/incident (18). Baseline morphine equivalents median was 120 mg.

• Multisite
• Hospice, hospital, and university settings
• The United Kingdom, Belgium, and Romania

Randomized, double-blind, placebo-controlled, parallel-group study

• Numeric Rating Scale (NRS), 0–10
• Brief Pain Inventory (Short Form) (BPI-SF)
• European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) Version 3.0
• Patient-generated diary
• Analysis of covariance (ANCOVA)

• Compared to the placebo and THC groups, approximately twice as many patients in the THC:CBD group had an NRS reduction from baseline of at least 30% (THC:CBD = 23 patients [43%], THC = 12 patients [23%], placebo = 12 patients [21%]).
• The THC groups showed a nonsignificant change, similar to the change in the placebo group.
• In median dose of opioid background medication and in mean number of doses of breakthrough medication across treatment groups, authors observed no change from baseline.
• Authors noted no significant group differences in sleep quality or nausea scores or in pain control assessment. However, the EORTC QLQ-C30 showed, compared to placebo, worsening of nausea and vomiting in the THC:CBD group. The EORTC QLQ-C30 showed no worsening of nausea and vomiting in the THC group.

THC:CBD may be of benefit as an adjunct to opioid when pain is not fully controlled despite chronic opioid therapy. However, this conclusion warrants further investigation; the EORTC questionnaire showed a worsening of nausea and vomiting in the THC:CBD group, compared to the placebo group. In addition, patients in this study reported a consistent impairment of cognitive function. In addition, though authors reported at least a 30% reduction in NRS from baseline in the THC:CBD group, from baseline no change occurred, across treatment groups, in median dose of opioid background medication or mean number of doses of breakthrough medication.

• Treatment models may have varied, country to country.
• The study was very short, with a duration of only two weeks.

THC:CBD extract—a nonopioid analgesic, endocannabinoid system modulator—may be a useful adjunct in managing the pain of patients who have inadequate analgesia from chronic opioids. However, one must consider the potential side effects (i.e. nausea, vomiting, impaired cognitive functions) that may occur as a result of adding this medication.

To test whether three breathing training sessions are better than one in patients with intrathoracic malignancy experiencing breathlessness

Participants were randomized to receive either one or three hour sessions of training in four techniques (breathing control, pacing/prioritizing, relaxation, and anxiety management). Those randomized to three sessions had the sessions at intervals spaced one week apart. All participants received written and DVD/video reinforcement material and a telephone call from their therapist a week after the final session. The training was provided by the professional who would normally be responsible for completing such training at the given clinical site and included physiotherapists, occupational therapists, and a lung cancer clinical nurse specialists. At two sites, the professionals were described as being a part of a specialist palliative care breathlessness intervention service. Outcomes were measured at week 4 and compared to baseline.

• N = 156   
• MEAN AGE = 69 years
• AGE RANGE = 38–92 years
• MALES: 60%, FEMALES: 40%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Patients had intrathoracic cancers (primary or secondary), refractory breathlessness with a self-reported intensity of less than or equal to 3 of 10 on a numerical rating scale (NRS), an expected prognosis of less than three months (clinician estimated), and no prior experience with breathing training.  
• OTHER KEY SAMPLE CHARACTERISTICS: Of note, only 3% of the participants had a non-lung cancer diagnosis (categorized in the study as “other”), 8% had mesothelioma, and 89% had primary lung cancer.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: England, Scotland, and Wales. Settings varied from hospitals, various outpatient oncology/lung/palliative/care outpatient clinics, to hospice units and patients’ homes.

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

• Randomized, controlled trial

• Patient reported worst breathlessness over last 24 hours as reports on a 1–10 NRS (primary outcome)
• Average intensity of breathlessness, distress due to breathlessness, coping with breathlessness, and satisfaction of breathlessness care as self-reported on a 0–10 NRS
• Injustice and catastrophizing scale
• Chronic Respiratory Questionnaire–Self-Administered Survey (CRQ-SAS)
• Hospital Anxiety and Depression Scale (HADS) 
• Karnofsky Performance Status Score
• EQ-5D and EQ visual analog scale (EQ VAS) for health status
• Brief COPE
• Clinical Global Impression of Change and health service utilization

• Primary outcome: Worst breathlessness as self-reported at week 4 was reduced in both groups with no significant difference between groups.
• Secondary outcomes: The average intensity of breathlessness and coping with breathlessness were similar between arms; distress and sense of mastery over breathlessness were worse in the three-session arm.

No evidence exists that three sessions of breathing training for patients with intrathoracic malignancy with breathlessness were beneficial, and no increased distress and mastery over breathlessness occurred in those receiving three sessions over one. A single session of training is recommended if breathing training is used for breathlessness.

• Risk of bias (no control group)
• Findings not generalizable
• While the study included only those with a prognosis of less than or equal to three months, 30 participants died over the eight weeks they were followed (greater than 10% of participants). While they were not dropouts, this number suggests that the prognostic inclusion criteria was difficult to control for but also that follow-up is missing on a number of the patients. Also, most of the participants had lung cancer, so study results may not be generalizable to other populations.

This study does not assess the effectiveness of breathing training over the standard of care for patients with cancer. If breathing training is considered based on other factors and other evidence, the nurse should be aware that this study does not support use of more than one session.