Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068328
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2003-09-10
Brief Title:
Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Observational Cohort Study Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable Newly Diagnosed Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-08
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 Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life
PURPOSE This clinical trial is studying how a patients treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer
PURPOSE This clinical trial is studying how a patients treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer
Detailed Description:
OBJECTIVES
Determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable newly diagnosed breast cancer
Determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients
Determine the relationships between preference-based chemotherapy decisions quality of life and satisfaction with treatment decisions in these patients
Determine the disease-free survival and competing causes of mortality of these patients
Determine the types of physician providers who care for older breast cancer survivors after initial cancer treatment is completed and explore how women decide about which physicians to see
Measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model
Determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment
Determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment
OUTLINE This is a cohort study
Patients participate in interviews over 30-45 minutes at baseline at 6 months and at 1 and 2 years
Patients are followed annually for at least 5 years
PROJECTED ACCRUAL A total of 1296 patients will be accrued for this study within 18-24 months
Determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable newly diagnosed breast cancer
Determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients
Determine the relationships between preference-based chemotherapy decisions quality of life and satisfaction with treatment decisions in these patients
Determine the disease-free survival and competing causes of mortality of these patients
Determine the types of physician providers who care for older breast cancer survivors after initial cancer treatment is completed and explore how women decide about which physicians to see
Measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model
Determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment
Determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment
OUTLINE This is a cohort study
Patients participate in interviews over 30-45 minutes at baseline at 6 months and at 1 and 2 years
Patients are followed annually for at least 5 years
PROJECTED ACCRUAL A total of 1296 patients will be accrued for this study within 18-24 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 |
|---|---|---|---|
| CDR0000321396 | REGISTRY | NCI Physician Data Query | None |
| CALGB-369901 | None | None | None |