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

NCT00068328 | Completed

• 2 other identifiers: CALGB-369901CDR0000321396
• Study Type: observational
• Target: 1,706
• Locations: 1 country
• Sites: 85

Brief 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. 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.

Conditions

Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

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

Outcome Measures

Primary Outcomes (1)

• quality of life

  Up to 5 years

Secondary Outcomes (2)

• disease free survival

  Up to 5 years

• mortality rate

  Up to 5 years

Study Arms (1)

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

Interventions

psychosocial assessment and care PROCEDURE

Group 1

quality-of-life assessment PROCEDURE

Group 1

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (85)

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Unknown Facility

Pismo Beach, California, 93449, United States

Location

Bendheim Cancer Center at Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Walter Reed Army Medical Center

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

Location

Cancer Center of South Florida Foundation, Incorporated

Lake Worth, Florida, 33461, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

La Grange Memorial Hospital

La Grange, Illinois, 60525, United States

Location

Center for Cancer Care at OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Suniti Medical Corporation

Merrillville, Indiana, 46410, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, 46563, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, 46391, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Sturdy Memorial Hospital

Attleboro, Massachusetts, 02703, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02115, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49443, United States

Location

Michiana Hematology Oncology PC - Niles

Niles, Michigan, 49120, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Saint Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

St. Anthony's Cancer Center

St Louis, Missouri, 63128, United States

Location

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

Grand Island, Nebraska, 68803, United States

Location

Callahan Cancer Center at Great Plains Regional Medical Center

North Platte, Nebraska, 69103, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

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

Concord, New Hampshire, 03301, United States

Location

Center for Cancer Care at Exeter Hospital

Exeter, New Hampshire, 03833, United States

Location

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Norris Cotton Cancer Center at Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Foundation Medical Partners

Nashua, New Hampshire, 03060, United States

Location

Oncology Center at St. Joseph Hospital

Nashua, New Hampshire, 03060, United States

Location

St. Barnabas Medical Center Cancer Center

Livingston, New Jersey, 07039, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Lipson Cancer and Blood Center at Rochester General Hospital

Rochester, New York, 14621, United States

Location

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cape Fear Valley Medical Center Cancer Center

Fayetteville, North Carolina, 28302-2000, United States

Location

Maria Parham Medical Center

Henderson, North Carolina, 27536, United States

Location

Southeastern Regional Medical Center

Lumberton, North Carolina, 28359, United States

Location

Granville Medical Center

Oxford, North Carolina, 27565, United States

Location

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Duke Health Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

Person Memorial Hospital

Roxboro, North Carolina, 27573, United States

Location

Marion L. Shepard Cancer Center at Beaufort County Hospital

Washington, North Carolina, 27889, United States

Location

Keyserling Cancer Center at Beaufort Memorial Hospital

Beaufort, South Carolina, 29902, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 29210, United States

Location

Coastal Cancer Center - Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Medical Oncology and Hematology Associates of North Virginia - Fairfax

Fairfax, Virginia, 22031, United States

Location

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

Huntington, West Virginia, 25702, United States

Location

Related Publications (6)

• 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.

  PMID: 22614985 RESULT

• 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.

  PMID: 20516438 RESULT

• 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.

  RESULT

• 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.

  PMID: 16598833 RESULT

• 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.

  PMID: 28653250 DERIVED

• 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.

  PMID: 28364214 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeanne Mandelblatt, MD, MPH

  Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: August 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2016
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (85)