Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer

Breast Cancer Clinical Trial

Official title: Psychobiological Pathways: Breast Cancer Interventions

Status Completed

Clinical Trial Summary

RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.

Clinical Trial Description

OBJECTIVES:

• Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.

• Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.

• Evaluate the efficacy of these intervention in these patients.

• Evaluate the nature and extent of coping strategies in these patients.

• Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).

• Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.

• Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.

• Arm III (control): Patients receive usual care and are not asked to attend any meetings.

All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study. ;

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

• NCT number: NCT00416780
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: N/A
• Completion date: March 2006