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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068328
  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
Cancer-Related Problem/Condition
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

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

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

Estimated Enrollment:   1296
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
    • 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
  • 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 62 study locations  Show 62 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


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

Publications of Results:

Study ID Numbers:   CDR0000321396, CALGB-369901
First Received:   September 10, 2003
Last Updated:   November 21, 2008
ClinicalTrials.gov Identifier:   NCT00068328
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
quality of life  
psychosocial effects/treatment  
stage I breast cancer  
stage II breast cancer  
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:
Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008




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