To evaluate a group cognitive-behavioral intervention to alleviate menopausal symptoms (hot flushes [HF] and/or night sweats [NS]) in women who have had treatment for breast cancer.

Following a two-week daily diary assessment, patients were offered six 90-minute weekly sessions of group cognitive-behavioral therapy (CBT). CBT included:  information and discussion about menopausal symptoms; monitoring and modifying stimulants that precipitate symptoms; relaxation and paced breathing; and techniques to reduce stress and manage HF, NS, and sleep. The primary outcome measures were HF frequency and HF problem rating. Secondary outcomes included scores on the Women’s Health Questionnaire (WHQ) and scores pertaining to health-related quality of life (HRQOL) as measured by the SF-36®. Beliefs about HF were monitored to examine the effects of CBT. 

• The study was comprised of 17 women receiving group CBT.
• Mean age was 53.7 years (range 46–65).
• Of the patients, 12 (71%) had undergone breast-conserving surgery; 3 (18%), modified radical mastectomy; 9 (53%), chemotherapy; 14 (82%), radiotherapy; and 12 (71%) were taking adjuvant hormonal therapies (11 were taking tamoxifen; 1 was taking anastrozole).
• At diagnosis, seven patients (41%) were premenopausal, six (35%) were in the early or late transition stage of menopause, and four (24%) were in the early or late postmenopausal stage.
• Average time since diagnosis was 23.2 months.
• Average duration of HF and NS was 2.1 years.
• Patients were treated in groups (of six, six, and five members); 12 women (59%) attended all six sessions, three women attended five sessions, and two attended three sessions. The majority (83%) completed all assessments.

• Multisite
• Outpatient
• Clinic staff recruited patients by using a database at two breast units in London, England.

• Patients were undergoing the transition phase of care:  after initial treatment and completion of chemotherapy and/or radiotherapy and with or without hormone replacement therapy.
• The study has clinical applicability for late effects and survivorship.

The study was a single-group, exploratory trial with pre- and posttreatment assessment after six weeks and three months.

• Hot Flush Frequency and Problem Rating Scale (HFRS) 
• WHQ
• Hot Flush Beliefs Scale (HFBS)
• SF-36® HRQOL ratings
• Daily diaries
   

• Weekly frequency of HF and NS was reduced from 75.7 to 46.9 (p < 0.03) at the posttreatment measure to 38.3 (p < 0.02) at the three-month follow-up. This change represents a 38% reduction at posttreatment and a 49% reduction at the three-month follow-up.
• Problem rating was reduced from 6.3 to 3.4 at posttreatment (p < 0.0001) and to 2.6 at follow-up (p < 0.0001).
• Depressed mood and anxiety significantly decreased from assessment to posttreatment (p < 0.02), and reductions were maintained at the three-month follow-up (p < 0.03).
• Sleep improved significantly (p < 0.003).
• Subscales of the SF-36® showed other significant improvements:  emotional role limitation (p < 0.0001), mental health (p < 0.01), energy/vitality (p < 0.0001), and general health (p < 0.003).
• Total scores on the HFBS decreased significantly, from 28.2 to 22.4 at posttreatment (t = 3.77; df = 16; p < 0.002), and were maintained at 22.7 at follow-up (t = 4.34; df = 16; p < 0.001). These reductions reflected a significant change in beliefs.

• Results suggest that CBT delivered in groups might offer a viable option for women with troublesome, undertreated, menopausal symptoms following breast cancer treatment, but further controlled trials are needed.
• CBT is consistent with the preferred treatment of women surveyed.
• Improvements continued after treatment, which may reflect the skills-learning aspect of CBT. HF and NS decreased, as did depressed mood and anxiety.
• Sleep improved, as reported by changes in WHQ ratings.
• Results showed no signficant improvement in specific dimensions of HRQOL, particularly emotional role limitation, energy/vitality, or mental health.

• The study had a small sample size, with less than 30 patients.
• The study is of limited generalizability.
• The main limitations of the study were lack of controls for placebo effects, attention, and spontaneous remission.
   

Nurses could be trained to conduct structured, interactive, group CBT with individual treatment goals. A randomized, controlled trial is recommended for further investigation.

Primary aim: To evaluate the effectiveness of group cognitive behavioral therapy (CBT) on hot flashes and night sweats in women who have had breast cancer

Secondary aim: To evaluate the effect of group CBT on depressed mood, anxiety, sleep, and quality of life

The intervention consisted of six group sessions using a psychoeducational approach with education regarding hot flushes, relaxation, stress management, and sleep strategies.

The intervention was delivered by a psychologist plus a trainee/intern.

Relaxation and paced breathing were demonstrated and practiced in each session, and participants were given a CD for ongoing use.

• The sample was comprised of 17 women with breast cancer.
• Mean age of participants was 53.7 years, with a range of 46–65 years.
• Average time since diagnosis was 23.2 months; 82% had received chemotherapy and radiation therapy, and 71% were receiving adjuvant hormonal therapies.
• Mean duration of hot flashes was 2.1 years.
• Of the sample, 70% were employed and 53% had more than 16 years of education.

• Single site (two breast units)
• Other setting
• London, England, United Kingdom

• Transition phase after initial treatment
• Late effects and survivorship

A pre/post-test design was used.

• Hot Flush Frequency and Problem Rating Scale (HFRS): Three 10-point Likert-type scales
• Daily hot flush diaries completed during a two-week assessment and at the end of treatment
• Women’s Health Questionnaire (WHQ): 36 items to assess mood and sleep
• Short Form 36 (SF-36): 36 items to assess health-related quality of life
• Hot Flush Beliefs Scale (HFBS)

Depression and anxiety decreased from baseline to post-treatment (p < 0.006; p < 0.02). Reductions maintained at the three-month follow-up.

Results suggest that group CBT may be an effective option for women who have menopausal symptoms following breast cancer treatment.

• The sample was small.
• Only 59% of participants completed all six sessions.

Participants had a mean duration of hot flushes of more than two years, suggesting that symptoms may have been unrelated to their recent cancer treatment and more associated with menopause.

To assess the tolerability of three ATL-104 doses and to assess the efficacy and safety of ATL-104 on mucositis in patients requiring high-dose melphalan or BEAM (carmustine, etoposide, cytarabine, and melphalan) before peripheral blood SCT (PBSCT)

This study included two parts. In the first part, patients were randomized to receive placebo or ATL-104 in doses of 50, 100, or 150 mg orally by mouthwash as a 15 mL total volume swilled in the mouth for 15-30 seconds and then swallowed. ATL-104 is a plant lectin associated with mitogenic activity and epithelial cell growth. Following harvest of PBSCs, patients received study treatment for three days before beginning a course of chemotherapy. For patients receiving BEAM, chemotherapy lasted for six days, whereas patients receiving high-dose melphalan had one day of treatment. PBSCT was administered 1–2 days after completion of chemotherapy, and patients then received three once daily doses of ATL-104. In the second part, patients were randomized to placebo or to one of the three ATL-104 doses.

• The study reported on 63 patients with a mean age of 53.3 years.
• The sample had 17 females and 46 males.
• The majority of patients (60.3%) received high-dose melphalan chemotherapy for multiple myeloma, and 39.7% received BEAM chemotherapy for lymphoma.

The study was conducted in an inpatient setting in the United Kingdom.

• Part 1 was a randomized, double-blind, placebo-controlled phase IIa dose escalation study.
• Part 2 was a randomized, double-blind, placebo-controlled parallel group study.

• The extent and severity of mucositis was assessed daily from screening until the final assessment, which was performed 28 days after the last dose of ATL-104 or at withdrawal.
• World Health Organization (WHO) and Western Consortium for Cancer Nursing Research (WCCNR) toxicity scales were used.

Treatment with ATL-104 substantially reduced the median duration of severe oral mucositis compared with placebo (median duration: ATL-104 for two to three days, placebo 10.5 days) (p < 0.001). The effect of ATL-104 on the incidence of severe oral mucositis was inconclusive. Adverse events (AEs) were mild to moderate in intensity with gastrointestinal (GI) AEs being most common.

ALT-104 substantially reduced the duration of severe mucositis and was well tolerated.

This study had inconclusive results regarding the incidence of severe mucositis. Further studies with a larger number of patients are needed to establish the effects of ATL-104 on the duration and severity of mucositis. Limited range of ATL-104 doses may be responsible for the lack of dose-response.

Mouthwashes are easy to administer; however, adherence is a concern when used preventatively or when the patient has oral discomfort or fatigue. The hospital setting allows for easier monitoring and assistance in promoting adherence. If further studies show a benefit to patients, cost and availability will be influencing factors toward good outcomes.

STUDY PURPOSE: To assess pain response after reirradiation in patients with painful bone metastases not sufficiently responding to initial radiation therapy or exhibiting recurrent pain after initial response

TYPE OF STUDY: Combined systematic review and meta-analysis

DATABASES USED: MEDLINE, EMBASE, and Cochrane Collaboration library

KEYWORDS: Radiotherapy, reirradiation, retreatment, bone metastases, palliative treatment

INCLUSION CRITERIA: All types of studies were allowed. Participants received reirradiation at the initial site of radiation for radiation-refractory metastatic bone pain. Both the initial treatment and retreatment consisted of external beam radiation therapy (EBRT). Reported outcomes were reported at least in response to initial reirradiation, and original research data were reported. If eligibility for inclusion could not be decided based on abstract screening, or if the abstract was not available, the full-text article was reviewed. To qualify for the meta-analysis, the study had to meet additional criteria: outcomes were available on an individual patient level, and the size of the study population was 10 patients or more.

EXCLUSION CRITERIA: Languages other than English, German, French, and Dutch

TOTAL REFERENCES RETRIEVED: 707

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Authors were contacted for missing data. Publication quality was assessed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) method. Data extraction and quality assessment was performed independently by two observers.

• FINAL NUMBER STUDIES INCLUDED = 10 (qualitative synthesis), 7 (meta-analysis)
• TOTAL PATIENTS INCLUDED IN REVIEW = 440
• SAMPLE RANGE ACROSS STUDIES: 11%–24% of patients observed received reirradiation, numbering from 4–173 cases
• KEY SAMPLE CHARACTERISTICS: Sample characteristics were available in two studies. One study (Van Der Linden et al.) reported that 61% of participants were male, 39% were female, the mean age was 65, and the mean Karnofsky Performance Status was 70. In a second study (Hayalshi et al.), it was reported that 57% of participants were male, 43% were female, the median age was 60, and the mean Eastern Cooperative Oncology Group (ECOG) performance status score was 2.5. Primary tumor types were breast (33%), prostate (21%), lung (23%), and other tumor types (23%). Reirradiated sites were localized to the spine (36%), pelvis (38%), proximal long bones (12%), and other locations (14%). Most patients were treated with single-fraction radiotherapy.

PHASE OF CARE: Transitional care after initial treatment

APPLICATIONS: Late-effects, survivorship, and palliative care

In this meta-analysis, 264 out of 440 patients achieved either complete or partial response with an overall response rate of 58%. Sensitivity analysis was not feasible. The complete response rate for reirradiation ranged from 16%–28%, and partial response rates were 28%–45%. Pooling was not appropriate due to the low number of studies. The time to response after reirradiation ranged from three to five weeks.

Approximately 60% of patients derived some benefit from the reirradiation of radiation-refractory bone pain. The time to response was three to five weeks. For those receiving reirradiation in a circumstance in which the end of life is near, this method may not be effective. Remission of pain, however, was reported to last anywhere from 15–22 weeks.

Not all studies reported drop-out rates and so an intention to treat analysis was not feasible. If reported, however, drop-out rates ranged from 14%–35%. These rates were attributed to death and symptomatic relief but were not clear, so bias could not be excluded. Further, no randomized, controlled trial has been published on reirradiation treatment for radiation-refractory metastatic bone pain. There is limited evidence on reirradiation effectiveness, study quality is mediocre, and populations are small. Also, the difference in study design, clinical differences between study populations, lack of clinical guidelines for reirradiation, and changes in insight over time contributed to the heterogeneity observed in the included studies. All of these factors again support the need for ongoing investigation of reirradiation for bone metastases and further investigation of palliative care measures to provide optimal relief for patients with painful bone metastases.

To assess the effectiveness of retreatment with radiotherapy for painful bone metastases

Data were collected from medical records. Only evaluable patients with pain response documentation were included in the analysis. Information from records was used to categorize pain because no numerical pain scores were recorded. For patients with available data, the pain response proportion was calculated. For those with no response data, it was assumed that these were nonresponders for the calculation of a worst-case scenario.

• N = 247
• MALES: 57%, FEMALES: 43%
• KEY DISEASE CHARACTERISTICS: Various tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: Overall, 56% of patients had multiple bone metastases, and the most frequent sites were spine, pelvis, and hips.

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

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

Retrospective, descriptive study

Not applicable

Overall, 66% of evaluable patients indicated responses with decreases in pain. In the worst-case analysis, the overall response rate was 43%. The use of systemic analgesia (overall response [OR] = 0.39, p = 0.037) and prior pain response to radiotherapy (OR = 1.01, p = 0.049) were predictors of response to repeat radiotherapy. Patients who had an initial response were more likely to respond to retreatment, and those having used systemic therapy were less likely to respond. The toxicities experienced were all grades 1 and 2, including nausea and vomiting, fatigue, diarrhea, and skin reactions. In 4% of patients, a pathologic fracture at the retreated site was reported, and one patient developed radiation-induced femoral head necrosis requiring a total hip replacement. For the initial treatment, it was reported that 13% of patients received no pain medication, and 43% had only levels 1 and 2 analgesia according to the World Health Organization analgesic ladder.

The findings of this study suggested that retreatment with radiation therapy for bone metastases can be effective for pain reduction. Prior response to radiation therapy for pain suggested better odds that retreatment would produce a response.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: No information was provided regarding whether any bone modifying agents were used. The initial analgesia used was low, and it was not clear if pain was maximally treated.

Patients who have initial pain responses to radiation therapy for bone metastases may benefit from repeat radiotherapy.

To examine changes in dyspnea through a randomized trial of high-flow oxygen (HFO) and bilevel positive airway pressure (BiPAP) in patients with cancer

Patients were randomized using a computer-generated randomization scheme in a 1:1 ratio to receive either two hours of HFO followed by a washout period and then two hours of BiPAP or two hours of BiPAP followed by a washout period followed by two hours of HFO. Data on dyspnea were collected every 10 minutes after the first intervention for as much as one hour. Patients participated in the second intervention if their dyspnea level was ≥ baseline dyspnea level minus one or  ≥ 3/10 after one hour.

• N = 30
• AVERAGE AGE = 61 years (range = 29–79 years)
• MALES: 47% (n = 14), FEMALES: 53% (n = 16)
• KEY DISEASE CHARACTERISTICS: Lung 43% (n = 13), head and neck 3% (n = 1), genitourinary 3% (n = 1), gastrointestinal 10% (n = 3), breast 17% (n = 5), other 23% (n = 7); cancer stage metastatic 87% (n = 26) and local 13% (n = 4); causes of dyspnea were pulmonary parenchymal lesions 70% (n = 21), pleural effusions 50% (n = 15), lymphangitic carcinomatosis 7% (n = 2), and other noncancer causes; not already on home supplemental oxygen 70% (n = 21); majority of participants (93%) on supplemental oxygen at the time of enrollment with a median of 3 L per minute and an average oxygen saturation of 95% (SD = 4%). 
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria: average intensity of dyspnea at rest over the past week ≥ 3/10 on a numeric rating scale despite the use of supplemental oxygen, life expectancy of more than one week, and English-speaking; exclusion criteria: hemodynamic instability, acute respiratory distress with impending intubation, delirium (Memorial Delirium Assessment Scale > 13/30), Glasgow Coma Scale < 8/15, contraindications to BiPAP, or noncancer-related dyspnea with supplemental home oxygen before hospitalization

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: MD Anderson Cancer Center

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

Randomized, open-label study with a parallel design and an optional second intervention

• Numeric Rating Scale (NRS), a measurement of dyspnea on a 0–10 scale
• Modified Borg Scale (MBS), an assessment scale for dyspnea
• Global symptom evaluation
• Memorial Delirium Assessment Scale (MDAS)
• Glasgow Coma Scale (GCS)

HFO and BiPAP were found to alleviate dyspnea and improve physiologic parameters. The results of this study justify larger randomized, controlled studies to validate these findings. The authors of this study proposed that HFO and BiPAP be examined separately.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Other limitations/explanation: Multiple statistical comparisons were conducted. Baseline arterial blood gas and a measurement of oxygen saturation while on room air were not conducted.

Dyspnea is one of the most common symptoms for patients with cancer. This study shows that HFO and BiPAP may alleviate dyspnea. These devices are safe for patients to use. Larger randomized, controlled clinical trials are needed to confirm the findings of this study.

To study the feasibility of a randomized, controlled trial exploring the effects of fentanyl on breakthrough dyspnea, walking distance, vital signs, and adverse events in patients with cancer

• N = 20  
• MEDIAN AGE = 55 years (range = 27–75 years) (mean age was 55 years in the fentanyl group 54 years in the placebo group)
• MALES: 45% (n = 9), FEMALES: 55% (n = 11)
• KEY DISEASE CHARACTERISTICS: Breast (5), gastrointestinal (1), genitourinary (3), gynecologic (2), lung (4), and sarcoma (5); other diseases were chronic obstructive pulmonary disease, heart failure, asthma, and bronchiectasis
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were included if they had a cancer diagnosis, were aged 18 years or older, had average intensity breakthrough dyspnea of three or more on a 10-point Numeric Rating Scale, spoke English or Spanish, were ambulatory with or without an assistive device, had a Karnofsky Performance Status of 50% or more, and were on a stable dose of strong opioids with a MEDD of 30–580 mg. Patients were excluded if their dyspnea scores at rest were seven or more out of 10, they used more than 6 L per minute of supplemental oxygen, they experienced delirium (Memorial Delirium Assessment Scale > 13 out of 30), they were allergic to fentanyl, they had history of substance abuse, they had a recent history of coronary artery disease, and if they had uncontrolled tachycardia or hypertension at the time of assessment.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Supportive Care Center at the MD Anderson Cancer Center

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

Double-blinded, placebo-controlled, randomized trial

• Numeric Rating Scale (NRS) to measure dyspnea from 0–10 (0 = no shortness of breath and 10 = worst possible shortness of breath)
• Borg scale to assess fatigue level
• Global Symptom Evaluation (GSE) to evaluate change in dyspnea following interventions
• Edmonton Symptom Assessment Scale (ESAS) and Cancer Dyspnea Scale (CDS) at baseline to assess the quality of dyspnea over the previous few days

The prophylactic administration of subcutaneous fentanyl appears to be a safe and well-tolerated method for reducing dyspnea, fatigue, and respiratory rate while also enhancing physiologic function and activity levels among patients with cancer. However, the generalizability of these findings are limited because of the small sample size.

• Small sample (< 30)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: The statistically insignificant improvement of dyspnea and fatigue among patients in the placebo arm was attributable to a placebo effect. According to the authors, a placebo effect within the context of this study may have been caused by a reporting bias, interviewer bias, or period/training effects. This suggests a need for the standardization of patient encounter experience and the stratification of baseline dyspnea levels. Also, routine subcutaneous administration may not be practical, and it requires some degree of training. The authors suggested rapid-onset fentanyl via transmucosal or intranasal routes as more practical alternatives.

To implement and evaluate an evidence-based practice change to encourage exercise for fatigue

The Iowa Model of Evidence-Based Practice Change was used to guide implementation and measure impact on patient outcomes and care processes. An intervention to implement physical activity for patients to combat fatigue was selected. Activity kits for patients were developed, and included information on the benefits of physical activity, activity logs, instructions for workouts, as well as strategies to improve sleep, and nutrition. A pedometer and resistance bands were also provided. A nurse made regular connections with patients to encourage physical activity. Fatigue assessment was done at clinic visits at baseline and three months later. Results from the physical activity group were compared to those of patients receiving usual care.

• N = 45  
• AGE: Not provided
• MALES (%): Not provided, FEMALES (%): Not provided

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

PHASE OF CARE: Multiple phases of care

Prospective cohort comparison

Brief Fatigue Inventory (BFI)

Patients who received the activity intervention experienced a significant reduction in fatigue (p = 0.0006) and increase in general activity (p = 0.0066).

The intervention to improve physical activity was effective to improve fatigue.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• A single DNP was involved in encouraging patients to continue physical activity, so if this type of practice change would be effective without the consistent follow-up of an individual is unclear.

The findings showed that the use of the activity kit and follow-up in this study was effective in increasing physical activity and reducing fatigue in patients with cancer.

To examine the effectiveness of an inpatient group psychoeducational intervention for caregivers of patients receiving inpatient palliative care

Five education group sessions were delivered using a standardized method, the components and conduct of which were developed by authors in the pilot study that preceded the current study. Each was 90 minutes, and they focused on five topics: what palliative care is, the typical role of family caregivers (CGs), available support services to help CGs, preparing for the future, and self-care strategies for CGs. Caregivers were also given the opportunity to arrange individual meetings with designated multidisciplinary team members based on their needs. CGs were referred formally to family meetings if needed.

• N = 126 in T1, 107 in T2   
• AGE = 57 years
• MALES: 33.3%, FEMALES: 66.7%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Adults receiving palliative care, patients with various advanced cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Adults aged older than 18 years, CGs of adults with cancer receiving palliative care, English speakers, adults willing to be recognized as a patient's primary CG. Those with significant emotional distress were excluded.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Australia

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

Pre-/postdesign

• Family CGs’ needs measured with the Family Inventory of Needs (FIN)
• Preparedness for CG role measured by the Preparedness for Caregiving Scale (PREP)
• Competence for the CG role measured by the Caregiver Competence Scale (COMP)
• General Health Questionnaire (GHQ) to determine if CGs were emotionally eligible to participate.
• All measures had an alpha greater than 0.87.
• Measurement occurred before the educational intervention and after three days.

• Significant (p = 0.028) but small effect (0.22) on FIN, indicating improvement in met needs
• Significant (< 0.001), moderate effect (0.43) on preparedness
• No significant change in general health or competence
• A significant difference between those who declared a religious affiliation (improved GHQ scores) and those who had no religion

The educational intervention showed a small to moderate effect on reducing CGs' unmet needs and improved their sense of preparedness. The intervention did not affect CGs’ competence, although a trend of improvement was observed. The intervention did not improve CGs’ psychological well-being (secondary outcome—intervention was not geared to improve psychological well-being).

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• Thirteen of the 52 educational sessions 1:1 rather than group

Educational interventions improved CGs' sense of preparedness and decreased their sense of unmet needs. They may help improve CGs’ competence.

To evaluate changes in family caregiver distress between the referral of a patient with advanced cancer to palliative care and eight weeks after patient death based on caregiver involvement in a theoretically- and home-based one-on-one psychoeducational intervention

Family caregivers of patients with advanced cancer enrolled in home-based palliative care services in Australia were randomized to usual care (control) or one of two experimental groups that received usual care and one of two versions of a psychoeducational intervention. One intervention included one home visit and three phone calls, and the other included two home visits and two phone calls to meet rural access issues with some caregivers. Caregivers received written information in a piloted tested guidebook to prepare for the caregiver role, and trained family caregiver support nurses (FCSNs) used intervention manuals to provide consistency in developing and implementing plans to meet family role and caregiver psychological well-being and educational needs. Caregiver distress was measured within a two-week period of patient referral to palliative care (baseline, time 1), one week after the four-week intervention (time 2), and eight-weeks after patient death (time 3).

• N = 298  
• MEAN AGE = Females; 59 years, males; 61.7 years (range = 22–88 years)
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: English-speaking adult primary family caregivers of patients with advanced cancer enrolled in home-based palliative care
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria included caregivers of patients with nonmalignant diagnoses or a defined poor functional status

• SITE: Multi-site    
• SETTING TYPE: Home    
• LOCATION: Three states in Australia

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

Randomized, controlled trial with two arms (two versions of intervention)

• General Health Questionnaire (GHQ): 12 items with a history of established reliability and validity

The study sample included 86% urban caregivers. Diverse patient and caregiver factors caused a 42% caregiver attrition rate between time 1 and time 3 that affected the measurement of caregiver psychological well-being at eight-weeks after patient death. Almost 80% of caregivers provided care to a spouse or parent and lived with the patient an average of six years. There was a significant effect for age (p < 0.001) and gender (p < 0.04), and a close significance of time (p < 0.06), but no significant interaction of time with intervention. Younger and female caregivers had worse (higher) GHQ scores, and an overall analysis indicated that the intervention ameliorated a usual rise in caregiver distress after patient death but did not fully prevent an insult to caregivers' psychological well-being.

Psychological distress decreased by eight weeks after patient death among the caregivers of patients with advanced cancer enrolled in palliative care services if caregivers received a psychoeducational intervention involving one home visit and three phone calls.

• Unintended interventions or applicable interventions not described that would influence results: Authors acknowledged the inconsistency of caregiver support services as part of palliative care services, which would have affected FCSN effect with identified intervention
• Subject withdrawals ≥ 10%

Trained FCSNs exert a powerful role in assisting the caregivers of patients with advanced cancer during the dying process, preventing the complications of prolonged grief. The implementation and evaluation of theoretically-based interventions, tailored to caregiver needs and sociocultural context, can support the efficient multidisciplinary team delivery of care to promote caregiver well-being.