We propose to conduct a multisite evaluation of a brief cognitive- behavioral intervention to promote quality of life and increase adherence to early detection regimens among first-degree relatives (FDRs) of newly- diagnosed breast cancer patients. A randomized trial and a diffusion component will be conducted.
The specific aims of the randomized trial are to: (1) evaluate the impact of Problem-Solving Training (PST) on adjustment and adherence in this population, and (2) identify subgroups of women who are most likely to benefit from PST (i.e., based on their baseline sociodemographic characteristics and coping styles). Subjects will be 16OO women ages 35 and older. They will identified through index breast cancer patients at six Comprehensive Cancer Centers which comprise the High Risk Breast Cancer Consortium. Subjects will be randomized to one of two study conditions: (1) General Health Counseling (control) and (2) Problem-Solving Training. The PST intervention is based on Lazarus's Transactional Model of Stress and Coping and on extensive research on cognitive-behavioral interventions. This nurse-delivered intervention is designed to promote adaptive problem appraisal and provide skills to identify and implement effective coping responses. Telephone interviews and mailed questionnaires will be completed 1-month pre-intervention to collect data on sociodemographics and coping styles (i.e., information- seeking vs. information-avoidance), and to establish baseline levels of mediating process variables (i.e., primary and secondary appraisals, coping efforts, problem-solving skill), quality of life outcomes (i.e., breast cancer worries, stress impact, mood functional health status) and adherence outcomes (i.e., mammography, clinical breast examination, breast self-examination). Follow-up interviews and mailed questionnaires will be administered at 3- and 12-months post-intervention to assess the short and long-term impact of the interventions. Regressive models will be used to identify key variables and causal processes associated with positive changes in outcomes. In addition, as part of a diffusion component, we will determine the feasibility, potential efficacy, and costs of delivering this intervention in local community hospitals. Through detailed process analysis, based on Diffusion Theory and Organizational Innovation Theory, we will assess program feasibility, participant and staff reactions to the program and the likelihood of program continuation in the community after the funding period. Cost analysis will be conducted to examine the costs of program implementation and payment mechanisms in the community setting.
