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

August 7, 2017 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1706

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 65 years and older diagnosed with adenocarcinoma of the breast.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1

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.
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: Up to 5 years
Up to 5 years
mortality rate
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jeanne Mandelblatt, MD, MPH, Lombardi Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 10, 2003

First Submitted That Met QC Criteria

September 10, 2003

First Posted (Estimate)

September 11, 2003

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-369901
  • CDR0000321396 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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