Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
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
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 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.
Interventions
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of life | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival | Up to 5 years |
| mortality rate | Up to 5 years |
Countries
United States
Outcome results
None listed