DESCRIPTION (provided by applicant): The purpose of this pilot study is to test the effectiveness of a telephone-delivered interpersonal counseling (TIP-C) intervention compared to a self-managed exercise program (SEP) and a usual care attentional control (UC) for symptom management (cancer treatment-related depressive symptoms and fatigue) and quality of life for rural women with breast cancer and their partners. We propose to evaluate the efficacy of the proposed intervention, targeting under-served rural white, non-Hispanic and Hispanic women and their partners. This feasibility study will allow us to examine the theoretical, logistical and methodological issues prior to conducting a full-scale clinical trial as the next phase in this research program to improve the health outcomes of women with breast cancer. The specific aims are to 1) examine the effectiveness of TIP-C compared to SEP and UC on rural women's and their partners' management of depressive symptoms and fatigue, quality of life, cancer knowledge, social support, stress and partner relations, 2) resolve any logistical issues relative to the TIP-C intervention, and 3) examine relevant methodological issues, such as determining adherence level needed to achieve desired outcomes. The design is a repeated measures experimental design with women and their partners assigned to one of three groups: 1) TIP-C, 2) SEP or 3) UC. The TIP-C intervention consists of six individual 30-minute telephone sessions with the women and three sessions with their partners. The SEP consists of six 10-minute phone calls to encourage adherence to a prescribed self-managed exercise program. UC will receive a resource list and six 10-minute calls to ask about general well being and answer any questions about the resource list, but no counseling or exercise encouragement. SEP and UC partners will receive 3 calls. About 75 rural women, 25 in each group, who are receiving treatment for breast cancer and their partners will participate in this study. Participants will be >21 years, English speaking, and will have access to a telephone. About 70% of the women will be white, non-Hispanic and about 30% will be Hispanic, primarily Mexican-American. The partner for this intervention will be any adult nominated by the woman. Women will be matched for cancer treatment type and schedule. Measurement will occur at baseline during enrollment in the study (T1), at the end of the intervention (T2), and one-month after the intervention (T3). Data will be analyzed using descriptive statistics, t-tests, and repeated measures ANOVA.
|Effective start/end date||3/1/03 → 2/28/06|
- National Institutes of Health: $151,500.00