Overview

This trial is active, not recruiting.

Conditions breast cancer, psychosocial effects of cancer and its treatment
Treatments psychosocial assessment and care, quality-of-life assessment
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date August 2003
End date December 2006
Trial size 1360 participants
Trial identifier NCT00068328, CALGB-369901, CDR0000321396

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
psychosocial assessment and care
quality-of-life assessment

Primary Outcomes

Measure
quality of life
time frame: Up to 5 years

Secondary Outcomes

Measure
disease free survival
time frame: Up to 5 years
mortality rate
time frame: Up to 5 years

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

Official title Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.