Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416780
First received: December 27, 2006
Last updated: May 29, 2013
Last verified: March 2006

December 27, 2006
May 29, 2013
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00416780 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
Psychobiological Pathways: Breast Cancer Interventions

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Supportive Care
  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Other: counseling intervention
  • Other: educational intervention
  • Procedure: psychosocial assessment and care
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
March 2006
Not Provided

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
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00416780
PMBC-HS05-182, CMU-00000603, MWH-99-062, CDR0000459773, FWA00004206
Not Provided
Not Provided
Pittsburgh Mind-Body Center at Carnegie Mellon University
National Cancer Institute (NCI)
Study Chair: Michael Scheier, PhD Pittsburgh Mind-Body Center at Carnegie Mellon University
National Cancer Institute (NCI)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP