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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068328
First received: September 10, 2003
Last updated: February 18, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
 Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Official Title: Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1360
Study Start Date: August 2003
Estimated Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Menopausal status

  • Not specified

Performance status

  • Any performance status

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068328

  Show 85 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Mandelblatt J, Sheppard V, Hurria A, et al.: Patient preference as a determinant of breast cancer adjuvant chemotherapy use in older women: CALGB #369901. [Abstract] J Clin Oncol 27 (Suppl 15): A-9544, 2009.

ClinicalTrials.gov Identifier: NCT00068328     History of Changes
Other Study ID Numbers: CDR0000321396, CALGB-369901
Study First Received: September 10, 2003
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013