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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416780
• Other study ID #: PMBC-HS05-182
• Secondary ID: CMU-00000603MWH-
• Status: Completed
• Phase: N/A
• First received: December 27, 2006
• Last updated: May 29, 2013
• Est. completion date: March 2006

Study information

• Verified date: March 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Other:
• counseling intervention

• educational intervention

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pittsburgh Mind-Body Center at Carnegie Mellon University	National Cancer Institute (NCI)