Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416780
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2006-12-27
Brief Title:
Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I Stage II or Stage IV Breast Cancer
Sponsor:
Pittsburgh Mind-Body Center at Carnegie Mellon University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Psychobiological Pathways Breast Cancer Interventions
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 questionanswer 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 15-hour post intervention interview and a 15-hour final interview 8 months after randomization
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study
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 questionanswer 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 15-hour post intervention interview and a 15-hour final interview 8 months after randomization
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FWA00004206 | Registry Identifier | PDQ Physician Data Query | None |
| CMU-00000603 | OTHER | None | None |
| MWH-99-062 | None | None | None |
| CDR0000459773 | REGISTRY | None | None |