The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.

OBJECTIVE: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. METHODS: Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. RESULTS: Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. SIGNIFICANCE OF RESULTS: It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

A controlled trial of methods for managing pain in primary care patients with or without co-occurring psychosocial problems.

PURPOSE: Pain, a common reason for visits to primary care physicians, is often not well managed. The objective of this study was to determine the effectiveness of pain management interventions suitable for primary care physicians. METHODS: Patients from 14 rural primary care practices (47 physicians) who reported diverse pain problems with (n = 644) or without (n = 693) psychosocial problems were randomized to usual-care or intervention groups. All patients in the intervention group received information tailored to their problems and concerns (INFO). These patients' physicians received feedback about their patients' problems and concerns (FEED). A nurse-educator (NE) telephoned patients with pain and psychosocial problems to teach problem-solving strategies and basic pain management skills. Outcomes were assessed with the Medical Outcomes Study 36-Item Short-Form and the Functional Interference Estimate at baseline, 6 months, and 12 months. RESULTS: Patients with pain and psychosocial problems randomized to INFOFEED+NE significantly improved on the bodily pain (P = .011), role physical (P = .025), vitality (P <.001), role emotional (P = .048), and the Functional Interference Estimate (P = .027) scales compared with usual-care patients at 6 months. These improvements were maintained at the 12-month assessment even though these patients had received, on average, only 3 telephone calls. Compared with usual-care patients, at 6 months patients who received INFOFEED alone experienced minimal improvements that were not sustained at the 12-month assessment. CONCLUSIONS: For patients with pain and psychosocial problems, telephone-based assistance resulted in significant, sustained benefit in pain and psychosocial problems.

Partner-guided cancer pain management at the end of life: a preliminary study.

This preliminary study tested the efficacy of a partner-guided cancer pain management protocol for patients who are at the end of life. Seventy-eight advanced cancer patients meeting criteria for hospice eligibility and their partners were randomly assigned to a partner-guided pain management training intervention, or usual care control condition. The partner-guided pain management training protocol was a three-session intervention conducted in patients' homes that integrated educational information about cancer pain with systematic training of patients and partners in cognitive and behavioral pain coping skills. Data analyses revealed that the partner-guided pain management protocol produced significant increases in partners' ratings of their self-efficacy for helping the patient control pain and self-efficacy for controlling other symptoms. Partners receiving this training also showed a trend to report improvements in their levels of caregiver strain. Overall, the results of this preliminary study suggest that a partner-guided pain management protocol may have benefits in the context of cancer pain at the end of life. Given the significance of pain at the end of life, future research in this area appears warranted.

Evaluation of an educational program for long-term care nursing assistants.

OBJECTIVES: To determine if an educational program can improve knowledge and attitude among ancillary staff on end-of-life care issues in a long-term care facility. DESIGN: A pilot study using a pre- and post-test design prior to and at the completion of an education intervention. SETTING: A long-term care facility in suburban Philadelphia that has 150 assisted living beds and 53 nursing home beds. PARTICIPANTS: Long-term care ancillary staff including certified nursing assistants (called "care managers" at this facility), social workers, recreational therapists, and food service workers. INTERVENTION: The intervention was a novel educational program consisting of five in-service lectures with accompanying take home self-study modules for ancillary staff in long-term care entitled "Dignity in Dementia." MEASUREMENTS: Ancillary staff attitudes and knowledge on end-of-life issues in dementia were assessed with a knowledge and attitude questionnaire pre- and post-intervention. One-year follow-up questionnaires were administered to assess long-term maintenance of knowledge and attitude changes. RESULTS: Thirty-two ancillary staff completed the pre-intervention questionnaires. Twenty-nine ancillary staff completed the post-intervention questionnaires (90.6%). There was a significant change in the end-of-life knowledge level of the ancillary staff (P =.0270). Specifically, there was a significant change in one question dealing with dementia as a terminal disease (P = .006). There were also significant changes in the average attitude scores of the ancillary staff. (P = .0242). One-year follow-up revealed that both knowledge and attitude changes were maintained. CONCLUSIONS: This pilot project demonstrates that a staff educational program on end-of-life care for dementia residents can improve end-of-life knowledge and attitudes among long-term care ancillary staff and that this improvement can be maintained for up to 1 year. This intervention is easily reproducible in the long-term care setting. This project is an important step in helping improve end-of-life care for dementia residents in long-term care settings by improving the knowledge and attitudes of their caregivers.

The self-efficacy of family caregivers for helping cancer patients manage pain at end-of-life.

This preliminary study examined the self-efficacy of family caregivers with regard to helping cancer patients manage pain at end of life. A sample of 63 family caregivers of hospice-eligible cancer patients with pain provided ratings of their self-efficacy in assisting the patient in pain management and rated their own mood and level of caregiver strain. Patients completed measures of pain and quality of life. Data analyses revealed that caregivers who rated their self-efficacy as high reported much lower levels of caregiver strain as well as decreased negative mood and increased positive mood. Caregiver self-efficacy in managing the patient's pain was related to the patient's physical well-being. In dyads where the caregiver reported high self-efficacy, the patient reported having more energy, feeling less ill, and spending less time in bed. Considered overall, the results of this study suggest that caregiver self-efficacy in pain management is important in understanding how caregivers adjust to the demands of caring for cancer patients who have pain at the end of life.