Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer - Full Text View

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

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:

Kreling B, Figueiredo MI, Sheppard VL, Mandelblatt JS. A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology. 2006 Apr 6; [Epub ahead of print]

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

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068328