Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031772
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2002-03-08
Brief Title:
S9832 Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Enhancing Well-Being During Breast Cancer Recurrence SWOG Study S9832
Status:
COMPLETED
Status Verified Date:
2013-02
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 Telephone counseling by breast cancer survivors may enhance the well-being and quality of life of women who have recurrent breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer
Detailed Description:
OBJECTIVES
Determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer
Determine the impact of sociodemographic clinical and psychosocial predictors of well-being in these patients
Determine the changes in well-being over time since disease recurrence in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over time since initial diagnosis less than 2 years vs 2 years or more and recurrence site soft tissue without bone vs soft tissue with bone vs visceral Patients are randomized to one of two study arms
Arm I control arm Patients receive the standard level of support by continuing to use existing resources Patients receive written materials from the counseling group at 6 months
Arm II intervention arm Patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions Patients receive written materials from the counseling group after the first session
In both arms quality of life is assessed at baseline and at 3 and 6 months
PROJECTED ACCRUAL A total of 300 patients 150 per study arm will be accrued for this study within 30 months
Determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer
Determine the impact of sociodemographic clinical and psychosocial predictors of well-being in these patients
Determine the changes in well-being over time since disease recurrence in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over time since initial diagnosis less than 2 years vs 2 years or more and recurrence site soft tissue without bone vs soft tissue with bone vs visceral Patients are randomized to one of two study arms
Arm I control arm Patients receive the standard level of support by continuing to use existing resources Patients receive written materials from the counseling group at 6 months
Arm II intervention arm Patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions Patients receive written materials from the counseling group after the first session
In both arms quality of life is assessed at baseline and at 3 and 6 months
PROJECTED ACCRUAL A total of 300 patients 150 per study arm will be accrued for this study within 30 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 |
|---|---|---|---|
| U10CA037429 | NIH | NCI | httpsreporternihgovquickSearchU10CA037429 |
| S9832 | OTHER | None | None |
| NCI-P02-0209 | OTHER | None | None |