Context: Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. Objective: To examine the effect of a standardized cognitive-behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Design: Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Participants: Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention: Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Outcome Measures: Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. Results: The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms ( p ¼ 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm ( p ¼ 0.02). Conclusions: The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time.

Clinical trials of investigational therapy in patients with advanced cancer may not pay sufficient attention to quality of life (QOL) and supportive care issues, resulting in an adverse impact on the quality of care (QOC). We hypothesized that the simultaneous delivery of investigational therapy and a structured program of supportive care would result in measurable improvements in predefined outcomes without adverse events for patients, caregivers, or the physician/patient interaction. This report describes the findings of a trial designed to test the feasibility and initial results of such an approach. Forty-four patients accrued to Phase I or Phase II investigational therapy trials were simultaneously enrolled into a defined home care program focused on supportive care needs of the patient and family, as well as assessment of the toxicities of investigational therapy. These 44 patients constitute the Simultaneous Care (SC) cohort. Twenty patients receiving investigational therapy and the standard supportive care measures available through the Cancer Center served as a control group, designated the Usual Care (UC) cohort. We measured QOL using baseline and monthly assessments of the Functional Assessment of Cancer Therapy (FACT-G) instrument. This instrument measures four domains of well-being: physical, emotional, functional, and social/family. We prospectively defined QOC as: the percentage of hospice referrals; hospice length of stay; and number of cycles of chemotherapy administered. A summary score for the four FACT domains at each time point for each patient was calculated (FACT 4). The FACT 4 scores of the SC group improved compared to the UC group but did not reach a significant difference. Individual scores reflected a wide range of psychometric variability. A statistically significant difference in referral to hospice was seen in the SC group (35/44) compared to the UC group (8/15) (P=0.034). The median length of stay in hospice was the same for both cohorts but the mean stay was greater in the SC cohort (54 days) compared to the UC cohort (37 days). The mean number of chemotherapy cycles was not different between SC and UC (P=0.25). The self-reported acceptance by patients, caregivers, physicians and Cancer Center support staff was qualitatively excellent. Patients with advanced cancer at the time of enrollment onto investigational therapy should have made an explicit transition to palliative care goals but often have not. In the current health care environment, patients with advanced cancer without curative potential may be forced by their health provider or health insurer to choose between disease-directed therapy (including investigational therapy) or structured best supportive care programs. In this emerging era of targeted therapies, SC provides an approach designed to optimize palliative care goals while supporting the clinical research mission of offering patients with advanced cancer new and potentially better therapeutic interventions. SC is a system of care that enhances patient choice by al...

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Prison populations throughout the Unites States are growing; the 1990s saw an average 6.5% per year increase. Average inmate age is increasing, as are both the number and rate of inmate deaths. Aging inmates experience health concerns typical of the general, free, aging population. Inmates have higher incidence of health complications associated with various circumstances, risk behaviors, and associated medical conditions. These circumstances include prison violence, incarceration-related constraints on exercise, and diet. Inmates are more likely to have a history of alcohol abuse, substance abuse or addiction and sex industry work. Risk-behavior conditions include human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), hepatitis B and C, liver disease, tuberculosis, endocarditis, and cardiomyopathy. Hospice is increasingly the preferred response to the health and care needs of terminally ill inmates. Implementing hospice behind bars has some unique challenges in addition to those inherent in hospice work. This series will provide an in-depth look at four hospice programs for inmates in the United States.