Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262899
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2005-12-06
Brief Title:
Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I Stage II or Stage IIIA Breast Cancer Make Treatment Decisions
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Genetic Counseling for Newly Diagnosed Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-01
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 Genetics education and counseling may help patients make treatment decisions It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer
PURPOSE This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ stage I stage II or stage IIIA breast cancer make treatment decisions
PURPOSE This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ stage I stage II or stage IIIA breast cancer make treatment decisions
Detailed Description:
OBJECTIVES
Compare the impact of rapid genetic counseling RGC vs usual care on the medical decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast cancer
Compare the impact of these interventions on the quality of life and psychological well being of these patients
Determine baseline factors that predict who is most and least likely to benefit from RGC in patients undergoing these interventions
Compare the cost per quality adjusted life year saved from a societal perspective in patients undergoing these interventions
OUTLINE This is a randomized multicenter study Patients are stratified according to participating site Patients are randomized to 1 of 2 interventional arms
Arm I rapid genetic counseling Patients undergo a 1½ hour genetic counseling session either in person or by telephone Patients who undergo telephone counseling receive a booklet of visual aids and educational materials Patient preferences and values are assessed immediately after counseling Some patients may undergo BRCA12 status determination Patients undergo follow-up telephone interviews at 1 6 and 12 months
Arm II usual care Patients receive a packet of breast cancer treatment educational materials Patient preferences and values are assessed 2 weeks later Patients undergo follow-up telephone interviews as in arm I
In both arms quality of life is assessed at baseline and at 1 6 and 12 months
After completion of the study patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study
Compare the impact of rapid genetic counseling RGC vs usual care on the medical decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast cancer
Compare the impact of these interventions on the quality of life and psychological well being of these patients
Determine baseline factors that predict who is most and least likely to benefit from RGC in patients undergoing these interventions
Compare the cost per quality adjusted life year saved from a societal perspective in patients undergoing these interventions
OUTLINE This is a randomized multicenter study Patients are stratified according to participating site Patients are randomized to 1 of 2 interventional arms
Arm I rapid genetic counseling Patients undergo a 1½ hour genetic counseling session either in person or by telephone Patients who undergo telephone counseling receive a booklet of visual aids and educational materials Patient preferences and values are assessed immediately after counseling Some patients may undergo BRCA12 status determination Patients undergo follow-up telephone interviews at 1 6 and 12 months
Arm II usual care Patients receive a packet of breast cancer treatment educational materials Patient preferences and values are assessed 2 weeks later Patients undergo follow-up telephone interviews as in arm I
In both arms quality of life is assessed at baseline and at 1 6 and 12 months
After completion of the study patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study
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 |
|---|---|---|---|
| R01CA108933 | NIH | None | None |
| R01CA074861 | NIH | None | None |
| P30CA051008 | NIH | None | None |
| GUMC-2004-212 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |