To evaluate the effects, in women with breast cancer, of moderated and peer-led online support group format on symptoms of depression and degree of participation

Investigator distributed recruitment material via postal mail, online, or through nonprofit organizations or the media. Interested women contacted the investigator after receiving or seeing recruitment material. Participants were placed into a moderated or peer-led group, in groups of 15 according to time of recruitment. All online support was accessed via a university-owned web page devoted to the work. Participants could not access groups to which they were not assigned. Moderators were master's-prepared social workers with experience with online and telephone help for people with cancer and their caregivers. Investigators obtained study measures at baseline and at 6, 12, and 16 weeks. The group was maintained for 12 weeks.

• The sample was composed of 50 participants.
• Mean patient age was 52.22 years, and the age range was 28–77 years.
• All participants were female.
• All participants had breast cancer and were to have completed treatment within the 32 days prior to inclusion.
• Most participants were married and white, and they reported an income above $50,000 annually. Most had stage I or II cancer and had received multimodal therapy. Of all participants, 96% were not taking any antidepressant.
   

• Single site
• Home 
• Newark, Delaware, United States
   

• Phases of care: multiple
• Clinical applications: late effects and survivorship

Longitudinal two-group design

Center for Epidemiological Studies Depression Scale (CESD)

At the end of the study, findings revealed no significant effects, on symptoms of depression, in regard to group, time, or time by group format. CESD scores in peer-led groups declined slightly at all study time points but were not significantly different from the scores of moderator-led groups. In both groups, symptoms of depression were mild. More messages were posted and read in moderated groups than in peer-led groups.

The study showed no effect of peer- or moderator-led online support groups on symptoms of depression in women with breast cancer.

• The study had a small sample size, with fewer than 100 participants.
• The study had risks of bias due to no blinding and the characteristics of the sample.
• The CESD was not sensitive enough to pick up significant changes, and the study was probably underpowered.
• The sample was self-selected, and participants tended to be affluent. Results would not necessarily be applicable to other groups. 
• Women with higher depression scores were in the peer-led group. Overall, all participants had low depression scores.
   

This study does not provide strong support for the effectiveness of either peer-led or moderated online support groups on symptoms of depression; however, at baseline the depression scores of most participants were fairly low, and study groups were not balanced on baseline depression symptoms. It is not clear if such support efforts are beneficial to individuals who do not have a high level of depression symptoms. This finding could have influenced study results. Research in this area should stratify samples on the basis of the level of symptoms at baseline.

STUDY PURPOSE: To assess the strength of evidence addressing qigong therapy in supportive cancer care and describe the definition of effective qigong therapy in supportive cancer care

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 11
• TOTAL PATIENTS INCLUDED IN REVIEW = 831 patients
• SAMPLE RANGE ACROSS STUDIES: 32–162 patients
• KEY SAMPLE CHARACTERISTICS: Wide variety of geographic regions; heterogeneous populations, of which 50% had breast cancer; wide variations in time of interventions from early treatment to recovery; patients receiving multiple treatment modalities

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

For the purpose of the reviewer’s comments, results were limited to the primary symptom of fatigue and two common concurrent symptoms, depression and fatigue. Five of the 11 studies included fatigue as an outcome measure. Measures improved significantly in groups using some form of qigong or tai chi intervention in four studies and showed no difference in the fifth study. Mixed benefits on depression were reported. No significant differences in sleep were reported. Constructs of qigong therapy were identified as slow, gentle, repetitious, flowing, weight-bearing movements, breath regulation, mindfulness, meditation, energy cultivation, and relaxation.

The authors reported growing research evidence that the practice of qigong has benefits for managing fatigue and improving quality of life in individuals with cancer. However, outcomes on mediation of inflammation/immune support, depression, anxiety, stress, mood, sleep, systolic blood pressure, and survival rate were reported as mixed, and, as only 4 or the 11 studies included samples from the U.S. (N = 389 of 831 participants included in the review [47%]), the validity of the conclusion is questionable for a broader to application to general supportive care across all populations with cancer.

• Limited search
• Limited number of studies included
• Mostly low quality/high risk of bias studies
• High heterogeneity
• Low sample sizes
• The technique requires expert skills to train participants
• Limited access to qigong expertise in U.S.
• Variations in constructs for qigong and limited descriptions of techniques of qigong intervention reported in studies

Logically consistent operational and conceptual definitions of qigong are needed for future research. Additional evidence is needed prior to recommending qigong to be integrated into cancer care. Access to trained qigong practitioners is needed for application to research across broad populations of patients with cancer.

Databases searched were MEDLINE, Embase, AMED, the Cochrane Database, Cancerlit, and CINAHL.

Search keywords were adult patients receiving chemotherapy, with nausea and vomiting duration or intensity measured as outcomes.

Two randomized controlled trials were identified involving 482 patients. The studies compared acupressure to no intervention control. However, the second study did not meet inclusion criteria, as transcutaneous electrical nerve stimulation (TENS) of antiemetic point was used.

Results suggested that acupressure may decrease nausea in patients receiving chemotherapy, but further work is required before conclusively advising patients on the efficacy of acupressure in preventing and treating chemotherapy-induced nausea and vomiting (CINV).

RESOURCE TYPE: Expert opinion

INCLUSION CRITERIA: Ipilimumab, colitis, perforation, metastatic melanoma

The authors developed an algorithm for caring for patients who develop diarrhea with ipilimumab treatment. Three case studies were outlined. In one study, a patient developed autoimmune colitis after an infectious diarrhea workup was negative, was treated with high-dose glucocorticoids, and improved. Another patient presented with bloody diarrhea, leukocytosis, negative stool cultures, and negative C-difficile. A colonoscopy showed severe active colitis with ulcerations that were inflammatory based on biopsy and pathology. The patient was treated with infliximab and improved. The third patient presented with nausea/vomiting, and diarrhea for one week, had negative stool and C-difficile cultures, no leukocytosis, and a normal erythrocyte sedimentation rate. Autoimmune colitis was noted on a sigmoidoscopy. The patient improved with glucocorticoids.

Case study of three patients, each with a different presentation. Two of the patients were octogenarians, and both developed more severe symptoms than the third patient, who was 51 years. Patient comorbidities were not identified.

Nurses need to carefully assess gastrointestinal symptoms in patients receiving ipilimumab to minimize complications.

To evaluate the effectiveness of a combination of aprepitant, palonosetron, and dexamethasone during the acute and delayed phase of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer receiving carboplatin-based, moderately emetogenic chemotherapy or cisplatin-based, highly emetogenic chemotherapy

• Day 1: Aprepitant 125 mg PO, palonosetron 0.75 mg IV, and dexamethasone 3.3 mg IV
• Days 2 and 3: Aprepitant 80 mg PO

• Day 1: Aprepitant 125 mg PO, palonosetron 0.75 mg IV, and dexamethasone 9.9 mg IV
• Days 2 and 3: Aprepitant 80 mg PO and dexamethasone 3.3 mg IV

• N = 133 courses
• MEAN AGE = 65.8 years
• MALES: 77%, FEMALES: 23%
• KEY DISEASE CHARACTERISTICS: Lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Prior experiences of CINV and motion sickness and a history of alcohol consumption

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Department of Respiratory Medicine at Sasebo City General Hospital in Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care 

This study was a prospective trial.

• Patients completed a self-reported questionnaire on the presence of emesis (yes or no), level of nausea (four choices), and status of salvage treatment. This questionnaire was completed on days 1–5.

Patients who received carboplatin or cisplatin-based chemotherapy had CINV, even with prophylaxis including aprepitant, palonosetron, and dexamethasone. There was no difference in CINV rates between patients who received carboplatin and those who received cisplatin-based chemotherapy. This study did not compare this regimen to any other prophylaxis, so it is difficult to draw a conclusion regarding the usefulness of this regimen for CINV prophylaxis for moderately or highly emetogenic chemotherapy.

• Risk of bias (no control group)
• Findings not generalizable
• Other limitations/explanation: This study only included patients with lung cancer who received carboplatin- or cisplatin-based chemotherapy. The prospective study included only one facility. The findings of this study may not be generalizable.

To determine the best antiemetic drug combinations for patients receiving moderately emetogenic chemotherapy (MEC)

Chemotherapy-naïve patients with a mix of malignancies receiving MEC were randomized to two treatment groups. Group A received palonosetron plus one day of dexamethasone and group B received fosaprepitant, granisetron, and dexamethasone on day 1. The primary endpoint was complete response (CR, no emesis and no rescue drugs). The secondary endpoints were complete control (CC, no vomiting, no use of rescue drugs, and no more than mild nausea), total control (TC, no nausea), and therapy chosen by patients. CR, CC, and TC were measured in the acute, delayed, and overall phases for five days. Data on chemotherapy-induced nausea and vomiting (CINV) were collected on days 2 and 5 following chemotherapy.

• N = 35
• AGE RANGE = 60 ± 14 years
• MALES: 37%, FEMALES: 63%
• KEY DISEASE CHARACTERISTICS: Solid malignant tumors (majority breast and colon)
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group performance statuses of 0, 1, and 2

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

• PHASE OF CARE: Active antitumor treatment

Prospective, single-blinded, randomized crossover study

• Japanese version of the ​Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT)
• Patients recorded the incidence and severity of CINV on days 2 and 5. The severity of nausea was recorded using a Numeric Rating Scale (NRS).

There were no significant differences in the efficacy of the two protocols, and no significant difference in CC or TC during the acute, delayed, or overall period was found. Nausea scores were not reported although their collection was reported. These results suggest that palonosetron and dexamethasone have the same efficacy as fosaprepitant, granisetron, and dexamethasone.

The combination of palonosetron and dexamethasone was as effective as triple-drug antiemetic regimens for patients receiving MEC.

• Small sample (< 100)
• Baseline sample/group differences of import
• Key sample group differences that could influence results
• Other limitations/explanation: CINV data were only collected on days 2 and 5.

The data from this study were not strong enough to affect nursing care; however, because of the similar efficacy of the study drugs, additional studies should be investigated.

To evaluate the antiemetic potential of palonosetron, aprepitant, and dexamethasone in patients with urothelial cancer receiving gemcitabine and cisplatin chemotherapy

Patients received one of two antiemetic regimens, ondansetron or granisetron plus dexamethasone, or palonosetron, aprepitant, and dexamethasone, and over one cycle of chemotherapy were evaluated for chemotherapy-induced nausea and vomiting (CINV) events, rescue medications needed, and food intake.

• N = 122   
• AGE RANGE = 36–82 years
• MEDIAN AGE = 68–70 years
• MALES: 86%, FEMALES: 13.9%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Urothelial cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving gemcitabine and cisplatin chemotherapy

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

• Nonrandomized, nonblinded, two-group comparison

• CINV events and anorexia were identified through review of the medical record and rated based on criteria from the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
• The rescue medications used were identified through the review of the medical record.

Patients in the palonosetron, aprepitant, and dexamethasone group had significantly fewer episodes of CINV, anorexia, and rescue medication used compared to the ondansetron or granisetron plus dexamethasone group during the first cycle of chemotherapy (p = 0.012) and overall during chemotherapy (p = 0.0019).

The use of palonosetron plus aprepitant and dexamethasone results in significantly fewer episodes of CINV, anorexia, and rescue medications used in people with urothelial cancer treated with gemcitabine and cisplatin as compared to another commonly used antiemetic regimen, ondansetron or granisetron plus dexamethasone.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• The two groups were different sizes: ondansetron or granisetron plus dexamethasone (n = 75), and palonosetron, aprepitant, and dexamethasone (n = 47), so the intervention effect may be influenced.

Palonosetron, aprepitant, and dexamethasone may offer more relief from CINV in people being treated with gemcitabine and cisplatin chemotherapy.

To examine the efficacy of family focused grief therapy on psychosocial functioning in families of patients who are terminally ill

Patients and relatives in several palliative care centers and hospices were recruited for the study. Families were randomly assigned to receive the focused grief therapy or usual care stratified based on recruitment site. Usual care consisted of standard palliative care provided by homecare programs, which involved counseling when deemed clinically appropriate. Focused grief therapy was provided by qualified family therapists who had received standardized training in the intervention. Clinical supervision of the therapists was provided throughout the trial, and fidelity to the intervention was independently evaluated from review of audiotaped sessions. Family focused grief therapy typically included four to eight sessions of 90 minutes provided across 9–18 months. It included exploration of family cohesion, communication, and handling of conflict. Families were assigned to functional classes: dysfunctional (sullen or hostile) or intermediate. Data at baseline and follow-up at 6 and 13 months postbereavement were obtained from relatives by a research assistant.

• The sample was comprised of 81 families in the intervention group (n = 232) and 28 families in the control group (n = 130).
• Mean participant age was 42 ±16 years: mean patient age was 57 years, mean spouse age was 56 years, and mean age of children was 29 years.
• The sample (all participants) was 54% female and 46% male.
• The most common cancer types were breast, lung, brain, and a mix of types.
• All patients were in palliative care or hospice programs and had a prognosis of six months.
• Median length of time from illness diagnosis to death was 25 months, and median survival from study entry was 96 days.
• Of the families, 51% were classified as intermediate functioning, 26% were designated as sullen, and 23% were categorized as hostile.
• Ninety-five percent of families had two or more children.

• Multisite
• Palliative or hospice care setting
• Eight different countries

A randomized controlled trial design was used.

• Family Environment Scale
• Family Relationships Index
• Family Assessment Device
• Brief Symptom Inventory
• Beck Depression Inventory (cognitive items)
• Social Adjustment Scale
• Bereavement Phenomenology Questionnaire

Among all participants, those receiving the study intervention had significantly greater change in mean score of the Brief Symptom Inventory (BSI) (0.12, p = 0.02). BSI showed a nonsignificant improvement at 13 months in the intervention group than in the control group. Grief phenomena diminished similarly in both groups. There was no significant difference in social adjustment in both groups. There were no other significant differences between groups. Among family members who were most distressed, differences were greater, with 0.83 improvement in the BSI (p < 0.01), Beck Depression Inventory (p < 0.01), and the Bereavement Phenomenology Questionnaire (p = 0.05). In both the intervention and control groups, the general patterns of change in outcomes measures showed overall decline in symptoms over time. Families with intermediate functioning who received the intervention had a larger reduction in conflict level at six months than intermediate families in the control group (p = 0.03). Hostile families that received the intervention deteriorated more than hostile control families over the 13 months of bereavement (p = 0.001). Intermediate families received an average of 7 sessions, sullen families received an average of 6.4 sessions, and hostile families received an average of 9.4 sessions.

Family focused grief therapy appeared to have some benefit for the most distressed family members in terms of reduction of symptoms; however, these changes were not accompanied by improvement in family functioning. This intervention may protect against pathologic grief in highly distressed individuals. Among hostile families, the intervention was counterproductive

• The study had a small sample (< 100).
• The study had many missing assessments (61 members) and a high refusal rate.
• Within the subgroup analysis of the most distressed individuals, only 20 families were represented. It is not clear how many were in the control versus the intervention groups—differences in scores reported may be greatly affected by differences in group size.
• The total number of individuals in this analysis was not provided.
• It is unclear if some of the measures were sufficiently sensitive to change in order to demonstrate response to interventions.
• Results among hostile families point to the potential for harm associated with this type of intervention.
• The study was conducted across nations that are very different (e.g., Australia, United Kingdom, Africa). It is not clear how cultural context could have affected findings, and distribution of cases did not enable relevant subgroup analysis.
• In the intervention group, 24% of families withdrew from the study, suggesting some degree of potential sample bias in the results. Functioning level of withdrawals was not reported.

Family focused interventions to mitigate grief issues may be helpful in some families for highly distressed individuals; however, among the most dysfunctional families, this type of intervention might be counterproductive. Additional research is needed to determine the appropriate role of this therapy approach in palliative care.

The intervention was cognitive-existential therapy (CEGT) provided in nine Australian hospitals. Existential themes of anxiety about death and uncertainty were incorporated into six goals of therapy: promoting a supportive environment, facilitating grief work over multiple losses, altering maladaptive cognitive patterns, enhancing problem-solving and coping skills, fostering a sense of mastery, and sorting out priorities for the future. The CEGT group had 20 weekly sessions, 90 minutes each, over six months. The control group had three 50-minute relaxation classes using progressive muscle relaxation with guided imagery. Measurements were taken at baseline, 6 months, and 12 months after the intervention. The intervention was offered by 15 therapists recruited from psychiatry, psychology, social work, occupational therapy, and oncology nursing staff. All therapists received specialized training and supervision through a series of workshops using 68-page manual.

• The sample was comprised of 303 women with stage I or II breast cancer stratified by nodal status, hormone receptor status, and tumor size.
• The intervention group (n = 154) received CEGT plus three relaxation classes.
• The control group (n = 149) received three relaxation classes.

Nine Australian hospitals

A randomized controlled trial/longitudinal study design was used.

• Monash Interview for Liaison Psychiatry (structured psychiatric interview validated with DSM-IIIR)
• Affect Balance Scale
• Hospital Anxiety and Depression Scale (HADS)
• Mental Adjustment to Cancer Scale (MAC)
• Family Assessment Device
• Satisfaction with therapy and other treatments

• Baseline screening showed that one-third of the sample suffered from a form of depressive disorder.
• The CEGT intervention group had reduced anxiety (p = 0.05, two-sided) compared to controls.
• Overall effect size for group intervention was small (d = 0.25).

• The CEGT model is recommended for use in patients with early breast cancer, and the supportive-expressive treatment model is recommended for patients with advanced breast cancer.
• The psychologist intervention group had a moderate mean effect size (d = 0.52); training and experience of the therapist make the intervention more effective.

• Both groups received three relaxation classes (minor design flaw).
• The intervention required specialized training needs for therapists.