NCT00068328

Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer

Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,706 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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 patient's 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 1,296 patients will be accrued for this study within 18-24 months.

Conditions

• Breast Cancer
• Psychosocial Effects of Cancer and Its Treatment

Interventions

Type	Name	Description
PROCEDURE	psychosocial assessment and care
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2003-08-01
• Primary completion: 2006-12-01
• Completion: 2016-12-01
• First posted: 2003-09-11
• Last updated: 2017-08-08

Locations

85 sites across 1 country: United States