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:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068328

  Hide Study Locations
Locations
United States, California
Camino Medical Group - Treatment Center
Mountain View, California, United States, 94040
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Pismo Beach, California, United States, 93449
United States, Connecticut
Bendheim Cancer Center at Greenwich Hospital
Greenwich, Connecticut, United States, 06830
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Cancer Center of South Florida Foundation, Incorporated
Lake Worth, Florida, United States, 33461
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
United States, Indiana
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Suniti Medical Corporation
Merrillville, Indiana, United States, 46410
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States, 02703
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Mercy General Health Partners
Muskegon, Michigan, United States, 49443
Michiana Hematology Oncology PC - Niles
Niles, Michigan, United States, 49120
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Missouri
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
St. Anthony's Cancer Center
Saint Louis, Missouri, United States, 63128
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States, 68803
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69103
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
Norris Cotton Cancer Center at Catholic Medical Center
Manchester, New Hampshire, United States, 03102
Foundation Medical Partners
Nashua, New Hampshire, United States, 03060
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, United States, 03060
United States, New Jersey
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Cape Fear Valley Medical Center Cancer Center
Fayetteville, North Carolina, United States, 28302-2000
Maria Parham Medical Center
Henderson, North Carolina, United States, 27536
Southeastern Regional Medical Center
Lumberton, North Carolina, United States, 28359
Granville Medical Center
Oxford, North Carolina, United States, 27565
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Duke Health Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Person Memorial Hospital
Roxboro, North Carolina, United States, 27573
Marion L. Shepard Cancer Center at Beaufort County Hospital
Washington, North Carolina, United States, 27889
United States, South Carolina
Keyserling Cancer Center at Beaufort Memorial Hospital
Beaufort, South Carolina, United States, 29902
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Coastal Cancer Center - Myrtle Beach
Myrtle Beach, South Carolina, United States, 29572
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Medical Oncology and Hematology Associates of North Virginia - Fairfax
Fairfax, Virginia, United States, 22031
United States, West Virginia
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
Cancer and Leukemia Group B
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:
Publications:
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014