Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 10, 2003
Last updated: February 18, 2011
Last verified: February 2011

September 10, 2003
February 18, 2011
August 2003
July 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00068328 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, 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.


  • 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.

Not Provided
Not Provided
  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
July 2005   (final data collection date for primary outcome measure)


  • 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



  • 65 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Any performance status

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
65 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000321396, CALGB-369901
Not Provided
Not Provided
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Jeanne Mandelblatt, MD, MPH Lombardi Cancer Research Center
Investigator: Alice B. Kornblith, PhD Dana-Farber Cancer Institute
Investigator: Hyman B. Muss, MD University of Vermont
Investigator: Stephen B. Edge, MD Roswell Park Cancer Institute
National Cancer Institute (NCI)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP