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AzTrials

Breast CancerNCT00068328

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

An observational study of Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Alliance for Clinical Trials in Oncology at 85 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older, women only
What is being tested?
psychosocial assessment and care and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
1,706 participants
Where
85 sitesUnited States
Study dates
Aug 2003to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

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

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

Trial locations and contacts

85 sites in 1 country.

85 sites in 1 country

United States85 sites

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Keyserling Cancer Center at Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Medical Oncology and Hematology Associates of North Virginia - Fairfax

    Fairfax, Virginia, 22031

  • Cape Fear Valley Medical Center Cancer Center

    Fayetteville, North Carolina, 28302-2000

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Bendheim Cancer Center at Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Maria Parham Medical Center

    Henderson, North Carolina, 27536

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Cancer Center of South Florida Foundation, Incorporated

    Lake Worth, Florida, 33461

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • St. Barnabas Medical Center Cancer Center

    Livingston, New Jersey, 07039

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Southeastern Regional Medical Center

    Lumberton, North Carolina, 28359

  • Norris Cotton Cancer Center at Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Suniti Medical Corporation

    Merrillville, Indiana, 46410

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • Mercy General Health Partners

    Muskegon, Michigan, 49443

  • Coastal Cancer Center - Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • Foundation Medical Partners

    Nashua, New Hampshire, 03060

  • Oncology Center at St. Joseph Hospital

    Nashua, New Hampshire, 03060

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Michiana Hematology Oncology PC - Niles

    Niles, Michigan, 49120

  • Callahan Cancer Center at Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Granville Medical Center

    Oxford, North Carolina, 27565

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Study site

    Pismo Beach, California, 93449

  • Michiana Hematology Oncology PC - Plymouth

    Plymouth, Indiana, 46563

  • Duke Health Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • Center for Cancer Care at OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Person Memorial Hospital

    Roxboro, North Carolina, 27573

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • St. Anthony's Cancer Center

    St Louis, Missouri, 63128

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Marion L. Shepard Cancer Center at Beaufort County Hospital

    Washington, North Carolina, 27889

  • Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Michiana Hematology Oncology PC - La Porte

    Westville, Indiana, 46391

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
psychosocial assessment and care, quality-of-life assessment
Keywords
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychosocial assessment and careProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

Study groups in NCT00068328
Study groupRoleWhat they receive
Group 1Patients 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.
Receives: Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quality of life

    Measured: Up to 5 years

Secondary outcomes (2)

  1. disease free survival

    Measured: Up to 5 years

  2. mortality rate

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionDec 2006
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,706 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068328
Sponsor's protocol ID
CALGB-369901
Other IDs
CALGB-369901, CDR0000321396
Status last verified
Aug 2017
First submitted
10 Sep 2003
Last updated
8 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Mandelblatt JS, Faul LA, Luta G, Makgoeng SB, Isaacs C, Taylor K, Sheppard VB, Tallarico M, Barry WT, Cohen HJ. Patient and physician decision styles and breast cancer chemotherapy use in older women: Cancer and Leukemia Group B protocol 369901. J Clin Oncol. 2012 Jul 20;30(21):2609-14. doi: 10.1200/JCO.2011.40.2909. Epub 2012 May 21.

    PubMed 22614985

  • Mandelblatt JS, Sheppard VB, Hurria A, Kimmick G, Isaacs C, Taylor KL, Kornblith AB, Noone AM, Luta G, Tallarico M, Barry WT, Hunegs L, Zon R, Naughton M, Winer E, Hudis C, Edge SB, Cohen HJ, Muss H; Cancer Leukemia Group B. Breast cancer adjuvant chemotherapy decisions in older women: the role of patient preference and interactions with physicians. J Clin Oncol. 2010 Jul 1;28(19):3146-53. doi: 10.1200/JCO.2009.24.3295. Epub 2010 Jun 1.

    PubMed 20516438

  • 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, Mandelblatt JS. A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology. 2006 Dec;15(12):1065-76. doi: 10.1002/pon.1042.

    PubMed 16598833

  • Bluethmann SM, Alfano CM, Clapp JD, Luta G, Small BJ, Hurria A, Cohen HJ, Sugarman S, B Muss H, Isaacs C, Mandelblatt JS. Cognitive function and discontinuation of adjuvant hormonal therapy in older breast cancer survivors: CALGB 369901 (Alliance). Breast Cancer Res Treat. 2017 Oct;165(3):677-686. doi: 10.1007/s10549-017-4353-y. Epub 2017 Jun 26.

    PubMed 28653250

  • Mandelblatt JS, Cai L, Luta G, Kimmick G, Clapp J, Isaacs C, Pitcher B, Barry W, Winer E, Sugarman S, Hudis C, Muss H, Cohen HJ, Hurria A. Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance). Breast Cancer Res Treat. 2017 Jul;164(1):107-117. doi: 10.1007/s10549-017-4222-8. Epub 2017 Mar 31.

    PubMed 28364214

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Alliance for Clinical Trials in Oncology at 85 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quality of life (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00068328, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.

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