Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006346
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2000-10-04
Brief Title:
Stress Reduction in Older Women With Stage II Stage III or Stage IV Breast Cancer
Sponsor:
Unity Health Toronto
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Stress Reduction For Breast Cancer in Women 55 Years of Age or Older Enhancing Quality of Life and Survival
Status:
COMPLETED
Status Verified Date:
2010-03
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 Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life
PURPOSE This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II stage III or stage IV breast cancer
PURPOSE This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II III or IV breast cancer
Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients
Determine baseline variables that contribute to predicting survival time in these patients
OUTLINE This is a randomized single blind to medical staff multicenter study Patients are stratified according to age and participation in support groups Patients with stage IV disease are also stratified according to type of metastases visceral vs non-visceral and timing of metastases first diagnosis vs recurrence Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive usual medical care and instruction on stress reduction using transcendental meditation TM which involves a standard 7-step course Patients attend training for approximately 1-15 hours per session for a total of 6 sessions over 1 week while receiving usual medical care Patients then practice TM twice a day for 20 minutes Patients attend group meetings for approximately 90 minutes once or twice monthly for 6 months to ensure proper technique and understanding
Arm II Patients receive usual medical care and basic literature on breast cancer
Quality of life is assessed at baseline and then every 6 months for up to 3 years
Patients are followed monthly for up to 25 years
PROJECTED ACCRUAL Approximately 166 patients 83 per treatment arm will be accrued for this study within 6 months
Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II III or IV breast cancer
Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients
Determine baseline variables that contribute to predicting survival time in these patients
OUTLINE This is a randomized single blind to medical staff multicenter study Patients are stratified according to age and participation in support groups Patients with stage IV disease are also stratified according to type of metastases visceral vs non-visceral and timing of metastases first diagnosis vs recurrence Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive usual medical care and instruction on stress reduction using transcendental meditation TM which involves a standard 7-step course Patients attend training for approximately 1-15 hours per session for a total of 6 sessions over 1 week while receiving usual medical care Patients then practice TM twice a day for 20 minutes Patients attend group meetings for approximately 90 minutes once or twice monthly for 6 months to ensure proper technique and understanding
Arm II Patients receive usual medical care and basic literature on breast cancer
Quality of life is assessed at baseline and then every 6 months for up to 3 years
Patients are followed monthly for up to 25 years
PROJECTED ACCRUAL Approximately 166 patients 83 per treatment arm will be accrued for this study within 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1618 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068177 | REGISTRY | None | None |