Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Psychosocial Effects of Cancer and Its Treatment |
Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | Psychobiological Pathways: Breast Cancer Interventions |
| Estimated Enrollment: | 350 |
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00416780 History of Changes |
| Other Study ID Numbers: | CDR0000459773, PMBC-HS05-182, MWH-99-062, CMU-00000603, FWA00004206 |
| Study First Received: | December 27, 2006 |
| Last Updated: | July 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
psychosocial effects of cancer and its treatment recurrent breast cancer stage I breast cancer stage II breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013