Trial Information

Psychobiological Pathways: Breast Cancer Interventions

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.