NCT Number: NCT00416780
Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
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.
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Notify MeKey information
Conditions
Age range
25 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Educational Intervention
Otherpsychosocial assessment and care
ProcedureSponsors and collaborators
Lead sponsor
Pittsburgh Mind-Body Center at Carnegie Mellon University
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Psychobiological Pathways: Breast Cancer Interventions
Important dates
- Study completion
- 2006
- First posted
- Dec 28, 2006
- Registry last updated
- May 30, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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