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Clinical Trials (PDQ®)

  • First Published: 8/24/2003
  • Last Modified: 2/16/2011

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Study of Chemotherapy Decisions and Outcomes in Women Age 65 and Over With Operable, Newly Diagnosed Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedEducational/Counseling/TrainingClosed65 and overNCICALGB-369901
NCT00068328

Objectives

  1. Determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable, newly diagnosed breast cancer.
  2. Determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients.
  3. Determine the relationships between preference-based chemotherapy decisions, quality of life, and satisfaction with treatment decisions in these patients.
  4. Determine the disease-free survival and competing causes of mortality of these patients.
  5. 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.
  6. Measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model.
  7. Determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment.
  8. Determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

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

Expected Enrollment

1360

A total of 1,296 patients will be accrued for this study within 18-24 months.

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.

Published Results

Mandelblatt JS, Sheppard VB, Hurria A, et al.: Breast cancer adjuvant chemotherapy decisions in older women: the role of patient preference and interactions with physicians. J Clin Oncol 28 (19): 3146-53, 2010.[PUBMED Abstract]

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.

Kreling B, Figueiredo MI, Sheppard VL, et al.: A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology 15 (12): 1065-76, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Jeanne Mandelblatt, MD, MPH, Protocol chair
Ph: 202-687-0812
Alice Kornblith, PhD, Protocol co-chair
Ph: 617-632-2640; 866-790-4500
Hyman Muss, MD, Protocol co-chair
Ph: 802-847-3827
Stephen Edge, MD, Protocol co-chair
Ph: 716-845-2918; 800-685-6825

Registry Information
Official Title Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older with Operable, Newly Diagnosed Breast Cancer
Trial Start Date 2003-08-01
Trial Completion Date 2005-07-21 (estimated)
Registered in ClinicalTrials.gov NCT00068328
Date Submitted to PDQ 2003-07-14
Information Last Verified 2011-02-16
NCI Grant/Contract Number CA84131

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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