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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068328
• Other study ID #: CALGB-369901
• Secondary ID: CALGB-369901CDR0
• Status: Completed
• Phase: N/A
• First received: September 10, 2003
• Last updated: August 7, 2017
• Start date: August 2003
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1706
• Est. completion date: December 2016
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Sturdy Memorial Hospital	Attleboro	Massachusetts
United States	Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Baltimore	Maryland
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	Keyserling Cancer Center at Beaufort Memorial Hospital	Beaufort	South Carolina
United States	Mountainview Medical	Berlin Corners	Vermont
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Saint Luke's Hospital	Chesterfield	Missouri
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Elkhart Clinic, LLC	Elkhart	Indiana
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana
United States	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire
United States	Medical Oncology and Hematology Associates of North Virginia - Fairfax	Fairfax	Virginia
United States	Cape Fear Valley Medical Center Cancer Center	Fayetteville	North Carolina
United States	Addison Gilbert Hospital	Gloucester	Massachusetts
United States	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center	Grand Island	Nebraska
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Bendheim Cancer Center at Greenwich Hospital	Greenwich	Connecticut
United States	Maria Parham Medical Center	Henderson	North Carolina
United States	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	St. Mary's Regional Cancer Center at St. Mary's Medical Center	Huntington	West Virginia
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Howard Community Hospital	Kokomo	Indiana
United States	La Grange Memorial Hospital	La Grange	Illinois
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	Cancer Center of South Florida Foundation, Incorporated	Lake Worth	Florida
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	St. Barnabas Medical Center Cancer Center	Livingston	New Jersey
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Southeastern Regional Medical Center	Lumberton	North Carolina
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	Norris Cotton Cancer Center at Catholic Medical Center	Manchester	New Hampshire
United States	Suniti Medical Corporation	Merrillville	Indiana
United States	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	Camino Medical Group - Treatment Center	Mountain View	California
United States	Mercy General Health Partners	Muskegon	Michigan
United States	Coastal Cancer Center - Myrtle Beach	Myrtle Beach	South Carolina
United States	Foundation Medical Partners	Nashua	New Hampshire
United States	Oncology Center at St. Joseph Hospital	Nashua	New Hampshire
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Michiana Hematology Oncology PC - Niles	Niles	Michigan
United States	Callahan Cancer Center at Great Plains Regional Medical Center	North Platte	Nebraska
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	Granville Medical Center	Oxford	North Carolina
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana
United States	Duke Health Raleigh Hospital	Raleigh	North Carolina
United States	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York
United States	Center for Cancer Care at OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Person Memorial Hospital	Roxboro	North Carolina
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	St. Anthony's Cancer Center	Saint Louis	Missouri
United States	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	Munson Medical Center	Traverse City	Michigan
United States	Marion L. Shepard Cancer Center at Beaufort County Hospital	Washington	North Carolina
United States	Walter Reed Army Medical Center	Washington, D.C.	District of Columbia
United States	Washington Cancer Institute at Washington Hospital Center	Washington, D.C.	District of Columbia
United States	Michiana Hematology Oncology PC - La Porte	Westville	Indiana
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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.

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 On — View Citation

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 chemoth — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life		Up to 5 years
Secondary	disease free survival		Up to 5 years
Secondary	mortality rate		Up to 5 years