NCT Number: NCT00068328
Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
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.
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Notify MeKey information
Conditions
Age range
65 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Camino Medical Group - Treatment Center, Mountain View, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
quality-of-life assessment
ProcedurePrimary outcomes
-
quality of life
Time frame: Up to 5 years
Secondary outcomes
-
disease free survival
Time frame: Up to 5 years
-
mortality rate
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer
Important dates
- Study start
- 2003
- Primary completion
- 2006
- Study completion
- 2016
- First posted
- Sep 11, 2003
- Registry last updated
- Aug 8, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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