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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed primary adenocarcinoma of the breast Operable disease Invasive and unilateral tumor No more than 20 weeks since diagnosis T1-4 (tumor size ≥ 1 cm), N0, M0 OR T1-4, N1-3, M0 No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer Hormone receptor status: Any estrogen receptor status PATIENT CHARACTERISTICS: Age 65 and over Sex Female Other No other malignancy except those for which the patient has completed treatment AND is considered to be at less than 30% risk of recurrence History of non-melanoma skin cancer allowed Sufficient cognitive function to consent to and complete interviews English or Spanish speaking

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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. | Procedure: psychosocial assessment and care<br> <br> Procedure: quality-of-life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | Up to 5 years | 
| mortality rate |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IA breast cancer, stage IB breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer