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

NCT ID: NCT00416780

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2006-03-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

counseling intervention

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

psychosocial assessment and care

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosed with breast cancer

• First-time diagnosis of stage I or II disease

• No more than 2 months since prior breast cancer surgery
• Initial diagnosis of stage IV disease
• Distant recurrence of prior breast cancer
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• Reside within a 60-mile radius of the greater Pittsburgh metropolitan area

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Pittsburgh Mind-Body Center at Carnegie Mellon University

OTHER

Sponsor Role: lead

Principal Investigators

Michael Scheier, PhD

Role: STUDY_CHAIR

Pittsburgh Mind-Body Center at Carnegie Mellon University

Other Identifiers

CMU-00000603

Identifier Type: OTHER

Identifier Source: secondary_id

MWH-99-062

Identifier Type: -

Identifier Source: secondary_id

CDR0000459773

Identifier Type: REGISTRY

Identifier Source: secondary_id

FWA00004206

Identifier Type: -

Identifier Source: secondary_id

PMBC-HS05-182

Identifier Type: -

Identifier Source: org_study_id