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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

Treatments: Procedure: quality-of-life assessment; Procedure: psychosocial assessment and care

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00068328

CDR0000321396 (Registry Identifier)

CALGB-369901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,706 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,706 participants in 1 patient group

Group 1

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care