To evaluate the effectiveness of an outpatient palliative care service

The specialized palliative care service included two physicians, two nurses, and a social worker specialized in palliative care providing home-based symptom management, 24-hour on-call services, psychological support, and coordination of care with local healthcare providers. Patients and caregivers completed study questionnaires at baseline and follow-up. Follow-up time frames ranged from a few days to seven weeks, with an average of 2.5 weeks. Questionnaires were completed in dialog with a trained psychologist

• N = 60 patients, 52 caregivers
• MEDIAN AGE = Patients: 67.5 years (range 32–97 years); caregivers: 41 years (range 29–91 years)
• FEMALES: 77% of caregivers
• KEY DISEASE CHARACTERISTICS: Not stated; all were in the end-of-life phase of care
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of caregivers were women and spouses.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: Germany

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

• Quasi-experimental

• Caregiver and patient questionnaires developed by researchers for this study
• Hospital Anxiety and Depression Scale

Patient and caregiver burden was significantly improved over the course of follow-up (p < .001). Caregivers and patients reported significant improvement in psychological support, support for activities of daily living, and communication between the patient and caregiver (p < .001). At baseline, 57% of caregivers showed clinically relevant anxiety scores (greater than 11), which decreased to 28% at follow-up (p < .001).

Palliative care services were associated with reduced caregiver perception of burden and reduced prevalence of clinically relevant anxiety among caregivers.

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Other limitations/explanation: Questionnaires used to measure burden were not known and validated measures.

Findings suggest that palliative care services significantly can reduce caregiver sense of burden. This is in concert with previous findings that multicomponent interventions are effective in reducing caregiver strain and burden.

To explore the safety and efficacy of psilocybin in patients with advanced cancer and anxiety

Each participant received two treatment sessions, one with placebo and one with psilocybin, provided in random order. A niacin placebo was used, and psilocybin was given orally at a 0.2 mg/kg dosage. Sessions took six hours, provided in a clinical research unit with direct constant staff observation. Vital signs were measured 30 minutes before drug ingestion and at hourly intervals. All had continuous Holter monitoring. Study instruments were administered the day before each session, the day after the session, two weeks after sessions, and at monthly intervals for the next six months. At the end of each session, participants discussed their experiences. Participants were followed via monthly phone calls.

• The study reported on a sample of 12 patients.
• Patient age range was 36–58 years (average not reported).
• The sample was 92% female and 8% male.
• All patients had advanced stage cancer, including breast, colon, ovarian, peritoneal, salivary gland, and multiple myeloma. Duration of diagnosis ranged from 2 months to 18 years. All patients had a DSM-IV diagnosis of acute stress disorder, generalized anxiety disorder, or adjustment disorder with anxiety.
• Patients were excluded if they had central nervous system disease, cardiovascular illness, other severe comorbid uncontrolled conditions, or lifetime history of psychiatric disorders.
• Of the sample, 75% had prior experience using hallucinogenic agents, including LSD, mushrooms, peyote, and ayahuasca.

• Single site
• Outpatient setting
• California

• Patients were undergoing end-of-life care.
• The study has clinical applicability for end-of-life and palliative care.

A within-subjects, double-blind, placebo-controlled study design was used.

• Beck Depression Inventory (BDI)
• Profile of Mood States (POMS)
• State-Trait Anxiety Inventory (STAI)
• Brief Psychiatric Rating Scale
• Five Dimension Altered States of Consciousness Profile

All patients completed three months of follow-up, and eight patients completed six months of follow-up. Psilocybin induced a mild but statistically significant elevation of heart rate and diastolic blood pressure compared to the placebo. Heart rate peaked at two hours, with a peak rate of 81.5 on average. Blood pressure also peaked at two hours at a mean of 138.9 systolic, compared to a baseline average of 117. Holter monitor recording showed no significant differences from placebo session results. BDI scores dropped by almost 30% from the first session to one month after the second session (p = 0.05). This difference was sustained for six months (p = 0.03). Improvement in POMs were observed in 11 patients after psilocybin administration. STAI results showed improvement in state anxiety at one month (p = 0.001) and three months (p = 0.03).

As administered here, psilocybin administration was associated with sustained improvement in depression and anxiety, with no serious cardiovascular adverse effects.

• The study sample was small, with less than 30 patients.
• Patients did know the difference in experience between psilocybin and placebo, so patient blinding was not realistically accomplished.
• Given the results with potential of long-term effect, the control condition was not really valid, except for immediate vital signs responses.

Studies done in the 1960s and 1970s showed that hallucinogens had therapeutic benefits for patients with terminal cancer, and this pilot feasibility study shows similar results. As provided here, administration of psilocybin was accomplished in a clinical research unit with constant staff monitoring, which may not be widely practical in terms of cost and manpower. Further research in the use of hallucinogens in patients with anxiety and depression are needed to determine the most appropriate dosages, and whether they can be used in a less controlled setting for therapeutic benefit. The majority of patients had prior experience with hallucinogens; it is not clear if similar results would be seen if patients had no such prior experience.

Evaluate whether a brief cognitive behavioral (CBT) intervention can reduce stress and distress in women with breast cancer and identify characteristics of those most likely to benefit

After pre-surgery assessment, women were randomized to the intervention or control conditions. Assessments were conducted post-intervention and 12 months later in both groups. Participants were accrued over a five-year period. The intervention focused on provision of relaxation training at every session with daily home practice to address phsyiologic, cognitive, and emotional aspects of stress. Sessions were provided in a group setting for three hours per week for five weeks. Women who lived a great distance from the center where sessions were held were offered transport and/or overnight accommodations. Data also were obtained at 12 months post-intervention.

• N = 179    
• MEAN AGE = 53.7 years (SD = 10.2 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS All had breast cancer; the majority were stage II or lower. Sixty-two percent had excision, and the rest had mastectomy.

• SITE:  Single site  
• SETTING TYPE:  Outpatient

PHASE OF CARE: Transition phase after active treatment

Randomized controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• Perceived Stress Scale
• Silver Lining Questionnaire

Reports of global stress were lower in the intervention group at the end of the study (p = .003), but no difference was observed between groups at 12 months. Analysis of covariance showed a significant group-by-time effect on anxiety scores, with the intervention group reporting greater decreases in anxiety immediately after the intervention (p = .03). However, no difference was observed between groups at 12 months. Depression scores did not differ between groups. Global stress and anxiety decreased more among participants with higher global stress at baseline.

A brief CBT approach intervention may be beneficial in reducing short-term stress and anxiety among women with breast cancer. However, individuals in this study had anxiety and depression levels on the HADS that are not generally deemed to be clinically relevant. No long-term benefits were observed.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Almost 50% loss to follow-up. Baseline anxiety and depression levels were not clinically significant, so measurement may have been subject to floor effects. Whether patients were in current treatment was unclear. The cost of transportation and accommodations may be prohibitive for this type of program for providers with a large catchment area. The control condition was not clearly described.

Findings suggest that CBT approach interventions in patient group settings might have a beneficial effect on stress and anxiety, but the study has several limitations. Effects seen were short-term, showing benefit immediately after the intervention, but were not maintained over the longer term. These results suggest that ongoing interaction probably is needed for patients to continue to practice relaxation and other behaviors.

To evaluate the evidence concerning the efficacy of Internet support groups (ISGs) in reducing symptoms of depression

• Databases searched were PubMed, PsycINFO, and Cochrane Database.
• Searched keywords were computer, Internet communication, and support.
• Studies were included if they employed an online peer-to-peer support group, incorporated either a depression outcome or involved an Internet support group relating to unipolar depression, or reported either quantitative or qualitative data.
• Authors did not specify exclusion criteria.
   

• Investigators retrieved a total of 158 studies.
• Investigators recorded study characteristics regarding design and other aspects of study quality. Investigators used no other method of quality evaluation.
• Of the studies retrieved, 16 involved a single component of peer-to-peer support. Of these 16, 4 reported that ISG had had a positive effect on symptoms of depression. Five of the 16 studies involved women with breast cancer.
• Twelve studies involved intervention components in addition to ISG. Only two of these reported positive results.
• Studies employed a bulletin board, chat room, or mailing list—alone or in combination. The duration of ISG intervention was 12 minutes to 12 months. Approximately 50% of interventions were moderated interventions, and the moderator was a healthcare professional.
• Only one study focused on rural participants.
• Of the final set of 28 studies, 9 involved patients with cancer. Most of these patients were women with breast cancer.
   

• The final number of studies included in the sample was 28.
• The mean range of participants was 10–2,373.
• Across studies, the median age range of patients was 26–65 years. Few samples focused on men, and most studies had a preponderance of women. 

• Multicomponent studies were less likely to yield significant positive outcomes than were stand-alone interventions (p = 0.01).
• Breast cancer ISGs were more successful than others (p = 0.02); however, all the studies involving ISGs originated from a single research group
• Authors noted no differences in outcomes between interventions involving chat rooms versus interventions involving static content.
• Authors noted no relationship between ISG participation and duration of intervention or ISG participation and outcomes or length of follow-up.
• Most studies were of low quality. Authors noted a correlation between low study quality and highly positive findings.
   

There is a need for high-quality research regarding the effect of ISGs on symptoms of depression.

This systematic review included data from studies available as of July 2007. Internet use and and social networking have increased since 2007—a fact that could alter the findings about the use and effect of ISGs. More research in this area is needed.

This review points to the need for high-quality research in this area. Theoretically, ISGs could be important for users who are isolated or unable to access face-to-face services readily; therefore, further research should be done.

STUDY PURPOSE: To explore whether family-involved interventions for reducing burden and improving caregiver skills improve five outcomes for adult patients diagnosed with cancer or memory-related disorders (more specifically, to explore the benefits of psychosocial interventions delivered by family or a caregiver as compared to usual care or wait-listed care for those patients), and to identify the benefits of a caregiver or family psychosocial intervention as compared to a different family-related intervention or patient-directed intervention for those patients

• FINAL NUMBER STUDIES INCLUDED = 27 
• SAMPLE RANGE ACROSS STUDIES: 12–476 (median of 120 dyads/sample)
• TOTAL PATIENTS INCLUDED IN REVIEW = 3,345 patients in analysis for 26 trials
• KEY SAMPLE CHARACTERISTICS: Patients: the average age was 60 years (range: 46–71 years); 80% were married; 51% were male, and the majority had prostate cancer; 49% were female, with most having breast cancer; 79% were white. Family members: the average age was 56 years (range: 49–62 years); 61% were female; no other family caregiver data reported

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Palliative care 

The systematic review, focused on five interventions for cancer, indicated some support for family-involved interventions over usual care for decreasing patient anxiety and depression. Weak evidence was found for better patient outcomes with family-involved interventions as compared to patient-focused or health education/psychoeducational interventions. Family-involved interventions, directed toward specific subgroups of patients and those involving teaching of skills to meet patient needs, may be more effective for alleviating cancer symptoms and depression and anxiety than usual care. Little evidence was found that symptom management (e.g., pain, fatigue, nausea), quality of life, or relationships adjustment between the patient and family caregiver improved following interventions examined for the systematic review. Only 2 of the 27 trials received a “good” quality evaluation, mandating caution in applying findings to practice.

The systematic review found heterogeneous studies and evidence that family-involved interventions improved patient depression but had little effect on their anxiety and physical health.

• Study findings resulted from 25 of 27 trials (RCTs) deemed as “poor” or “fair” in quality without observational evidence to support other findings.
• Some studies focused on interventions specific to improving caregiver and family health, which was not the review focus.
• Study samples were limited to those with cancer or memory-related illness.
• Non-inclusion of large-scale interventions similar to those used by the Department of Veterans Affairs
• Lack of data to assess the intervention effect on healthcare utilization
• Limited study generalizability

Current evidence indicates that targeted interventions for specific conditions, behaviors, and symptoms of the cancer experience may improve patient outcomes and minimize caregiver burden. Previous evidence has shown that psychosocial/psychoeducational interventions with caregivers reduce caregiver strain and burden. Findings from this systematic review provide some evidence that such interventions aimed at the family, rather than the individual caregiver or caregiver/patient dyad, may not substantially improve caregiver outcomes, while skill training for family members may be helpful. Additional work in this area is needed to determine the best foci and method of delivery of these types of interventions.

To evaluate the effect of fiber on bowel function by comparing increased fiber intake with instructions versus regular diet.

Women were randomized into two groups: high fiber (treatment) or regular diet (control). Both groups were evaluated at one, four, and seven months after surgery.

The treatment group received dietary counseling with instructions to increase their dietary intake to 30 to 40 g per day. Patients received all-bran cereal (unmarked) containing 15 g of fiber per bowl. Patients also were encouraged to increase their intake of insoluble fibers (eg, whole-grain, whole-wheat, and pumpernickel breads; all-bran cereal; butter; lima, pinto, and white beans; split and black-eyed peas; blackberries; boysenberries; raspberries; dried figs and prunes; artichokes; asparagus; Brussels sprouts; corn; parsnips; spinach; winter squash; turnip greens).

The study reported on a sample of 35 women with cervical cancer who had a type II or III radical hysterectomy.

University of Texas MD Anderson Cencer Center

This was a randomized controlled trial (RCT).

• Use of medications to achieve regularity was measured in terms of straining and pain with elimination.
• Patients completed subjective questionnaires, exercise log (seven days), food diary (three days), and bowel function assessment (seven days) at intervals. 

• Mean daily dietary fiber intake was 22.4 g in the treatment group and 12.4 g in the control group.
• Insoluble fiber intake for the treatment and control groups was 16.2 g and 8.1 g, respectively.
• Caloric intake was discussed.
• Patients in the control group had a significant increase in the amount of medications used to achieve regularity; no other significant changes existed pre-/postoperation in either group.

Patients with higher fiber intake had significantly less cramping abdominal pain and reports of straining, bowel-movement retention, more bowel movements with gas, and made in less than three minutes.

• The sample size was small (fewer than 100). Although this was an RCT, the sample size of 35 could be considered a major flaw and, therefore, decreased the impact level of evidence.
• The sample comprised women only.
• Findings were postsurgical only; presurgical fiber intake for the control group (10 g) was significantly higher than in the treatment group (7 g, p = 0.005).

To test the safety, tolerance, and efficacy of an appetite stimulant and an anabolic beta 2 agonist in patients with cancer cachexia

Patients were asked to take formoterol 40 mcg and megestrol 320 mg each morning and 40 mcg formoterol and 160 mg megestrol each evening for eight weeks. Self-reported intake and tablet counts were used to determine patient adherence. Patients were admitted to a clinical research facility on day 1 and discharged after the first dose of study drugs. Patients were contacted by phone after 24 hours for assessment. Additional assessments were done at weeks 2, 4, 6, 8, and 12.

• N = 9 (completed four weeks); 7 (completed eight weeks)  
• MEDIAN AGE = 67 years
• MALES: Not provided, FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: All had advanced disease; specific types were not described.
• OTHER KEY SAMPLE CHARACTERISTICS: Mean weight loss was 11% body weight over the prior five to seven months. 

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Scotland

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Single arm observational

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI's CTCAE) version 3.0
• Body weight
• Maximum isometric knee extensor, lower limb extension, and maximum handgrip strength via dynamometry
• Muscle size measurement via MRI
• Physical activity measured via accelerometry as average daily step count
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30 questionnaire

Patients showed an increase in muscle strength and muscle size. Mean body weight increased by 2.6%. Physical activity increased in three of six patients who responded to treatment. Appetite improved (p = .005). Adverse events were tremor (n = 7), peripheral edema (n = 3), tachycardia (n = 2), and dyspepsia (n = 2).

The combination of megestrol and formoterol may have benefit for patients with cachexia. The sample size of this study was too small to draw conclusions.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: Four patients discontinued possibly due to study drug; 40% overall attrition

The combination of medications tested here may be associated with improved muscle function and appetite in patients with advanced cancer; however, due to the limitations of this study, efficacy and tolerance is not clear. Further well-designed research with these medications is needed to determine efficacy, safety, and tolerance.

To determine the feasibility and usefulness of providing brief behavioral interventions to manage dyspnea in patients with advanced lung cancer

Participants received two 30-minute intervention sessions by the same nurse practioner, the second session provided within four weeks of the first. Two nurse practioners were trained in psychoeducation, behavioral techniques, and relaxation. The first session consisted of the nurse practioner explaining cognitive behavioral therapy and the effects of breathlessness, triggers, physiological factors, and behavioral responses on patients. Patients were taught pursed lip breathing, how to use a battery-operated fan, postural techniques, relaxation exercises, diaphragmatic breathing, and meditation. Participants were provided MP3 players with a recording of the guided breathing exercises to practice at home. The second intervention session consisted of reviewing and reinforcing the above instruction, answering questions, and identifying problems or obstacles.

• N = 32   
• AGE = 63.34 years
• MALES: 43.7%, FEMALES: 56.3%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Advanced lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, ongoing outpatient oncology treatment, English language literacy, and Modified Medical Research Council Dyspnea Scale (MMRCDS) score of less than or equal to 2 

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Scheduled visits in an outpatient infusion suit and a follow-up appointment or telephone call

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

• Pre/post design

Participants completed three measurements: the MMRCDS, the Functional Assessment of Cancer Therapy–Lung Trial Outcome Index (FACT-L TOI), and the Hospital Anxiety and Depression Scale (HADS) at baseline and again postassessment (six weeks after enrollment). Also used was the enrollment rate/study completion rate to examine feasibility.

Fifty-seven patients were referred to the study with 32 patients enrolled. Four patients could not complete it and one withdrew, leaving 27 participants completing all study procedures (84%). First intervention sessions were provided in the infusion suite, and half of the second sessions were provided in the infusion suite and half over the phone. Participants reported reduction in dyspnea (MMRCDS) over time and improvement in quality of life (QOL) (FACT–L TOI) and depression (HADS), but no significant differences in anxiety. Results were unchanged for all outcomes when adjusting for primary and secondary analyses for the line of chemotherapy.

This study demonstrates the feasibility and possible benefit of providing brief behavioral interventions to patients with advanced lung cancer to decrease breathlessness, improve QOL, and decrease depression. The study showed that a potential barrier may be the availability of resources and time for staff in cancer centers to provide education and training to patients. With a small sample size and pre/post design, larger randomized controlled studies are needed to determine intervention effectiveness.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Patients may have simultaneously responded to chemotherapy resulting in decreased breathlessness.
• Recruitment limited to clinician referral
• Homogenous sample limited the generalizability of results.
• The racial makeup was 93% Caucasian, and 63% were college graduates.
• Participants consisted of only patients with lung cancer.

Dyspnea, which impairs QOL, is a common symptom in patients with advanced lung cancer. Oncology nurses are in unique position to assess dyspnea and how it relates to patient distress and overall QOL. Nurses trained in strategies and interventions to decrease dyspnea are also in a unique position to provide this education to their patients.

To examine the use of cognitive-behavioral therapy (CBT) as an intervention to reduce anxiety in patients diagnosed with terminal cancer

CBT was adapted by the development of training modules targeting skills for relaxation, coping, and activity pacing. Eligibility included patients who were 18 years or older with an incurable solid tumor, four weeks post-diagnosis, and found to have anxiety as evidenced by a Hamilton Anxiety Rating Scale (HAM-A) score of 14 or higher. They were screened via telephone and met with a licensed clinical psychologist or postdoctoral psychology fellow for a baseline assessment and self-report questionnaires. If criteria was met, they were randomized to either individualized CBT or a wait-list control group. The intervention group met with a therapist for six to seven (optional) weekly sessions of CBT tailored to patient concerns. A post-treatment or eight-week assessment with a blinded independent evaluator was used, and the nonintervention patients were then able to cross over to receive CBT if desired.

• The study reported on a sample of 40 patients.
• Mean patient age was 55.90 years, with a range of 31–81 years.
• The sample was 70% female and 30% male.
• Patients were diagnosed with lung (30%), pancreatic (17%), colorectal (15%), other (38%) cancers.
• Patients had solid tumors only and were mostly white (95%).
• Demographic characteristics did not differ between the two groups.

• Single site
• Outpatient setting
• Massachusetts General Hospital Cancer Center

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A pilot feasibility and randomized controlled trial design was used.

• For the clinician-administered assessment, the primary outcome measure was total score on the HAM-A
• Montgomery-Asberg Depression Rating Scale (MADRS)
• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• Functional Assessment of Cancer Therapy–General (FACT-G)

Forty patients with terminal cancers were randomized to receive CBT (n = 20) or to a wait-list control group (n = 20), with 70% completing the post-treatment assessments. In the treatment group, 80% completed at least five of the six required sessions. Analysis revealed that those receiving CBT had greater improvements in HAM-A scores compared to the control group, with an adjusted mean difference of -5.41 (95% confidence interval: -10.78 to -0.04) and a large effect size for intervention (Cohen’s d = 0.80).

It was found that the majority of patients in the intervention sample were able to complete the requirements of the trial, and beneficial effects were observed in reducing anxiety and improving quality of life over time, but no significant differences in depression between the two groups.

• The study had a small sample size, with less than 100 participants.
• Study findings are not generalizable.
• The intervention was expensive, impractical, or had training needs.
• The use of routine screening procedures would be beneficial.
• The sample lacked racial and ethnic diversity, limiting generalizability to minority patients.

Patients who are newly diagnosed with incurable cancer can be at high risk for anxiety. The early identification of these patients and assisting them in accessing care using CBT can lead to significant improvements in anxiety and quality of care.

PURPOSE: To provide evidence-based and consensus recommendations for the management of cancer-related pain to guide practice by assessing existing guidelines to develop standards of care

TYPES OF PATIENTS ADDRESSED: All patients with cancer including pediatric cases, the elderly, the cognitively impaired, and culturally diverse patients. Both non-cancer and cancer-related pain guidelines were considered.

APPLICATIONS: Elder care, end of life care, pediatrics

The reference provides AGREE scores for 11 aspects of pain management across eight published guidelines as well as detailed recommendations for each of these aspects of pain management.

• Patient self-report is the most reliable indicator of pain.
• Valid assessment tools need to be used and need to be age and population appropriate.

• Establish a written plan for pain management. Patients, family members, and caregivers should receive a written pain management plan. 
• The plan should be updated upon reassessment. Adherence to the plan and other factors should be reassessed at regular intervals and with each new report of pain.

• A key principle is to titrate analgesic dosage to achieve desired pain relief and minimize unwanted side effects.  
• Specific guidelines for opioid use, management of breakthrough pain, principles for dose titration, and use of long acting opioids when dosages are stable are provided. It is recommended that the same opioid for breakthrough pain is used for round-the-clock dosing, and opioid rotation should be considered.

• Side effects should be anticipated, and prophylactic treatment should be instituted.

• These agents are important adjuncts for pain control. Anticonvulsants and antidepressants provide analgesia for specific types of pain. These should be used with extra caution in the elderly.