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

Psychobiological Pathways: Breast Cancer Interventions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00416780
Enrollment
350
Registered
2006-12-28
Start date
Unknown
Completion date
2006-03-31
Last updated
2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatment, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IV breast cancer

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.

Interventions

OTHERcounseling intervention
OTHEReducational intervention
PROCEDUREpsychosocial assessment and care

Sponsors

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

Study design

Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026