Clinical trial NCT00068328: Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
Official title: Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-11
Enrollment: 1706
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 65 years and older diagnosed with adenocarcinoma of the breast.

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.

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 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

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

Primary outcomes:
measure: quality of life
timeFrame: Up to 5 years
Secondary outcomes:
measure: disease free survival
timeFrame: Up to 5 years
measure: mortality rate
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Camino Medical Group - Treatment Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Pismo Beach
country: United States
state: California
city: Greenwich
country: United States
facility: Bendheim Cancer Center at Greenwich Hospital
state: Connecticut
city: Washington, D.C.
country: United States
facility: Washington Cancer Institute at Washington Hospital Center
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Lake Worth
country: United States
facility: Cancer Center of South Florida Foundation, Incorporated
state: Florida
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Chicago
country: United States
facility: Louis A. Weiss Memorial Hospital
state: Illinois
city: La Grange
country: United States
facility: La Grange Memorial Hospital
state: Illinois
city: Rockford
country: United States
facility: Center for Cancer Care at OSF Saint Anthony Medical Center
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC
state: Indiana
city: Elkhart
country: United States
facility: Michiana Hematology-Oncology, PC - Elkhart
state: Indiana
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Kokomo
country: United States
facility: Howard Community Hospital
state: Indiana
city: La Porte
country: United States
facility: Center for Cancer Therapy at LaPorte Hospital and Health Services
state: Indiana
city: Merrillville
country: United States
facility: Suniti Medical Corporation
state: Indiana
city: Mishawaka
country: United States
facility: Michiana Hematology-Oncology, PC - South Bend
state: Indiana
city: Mishawaka
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: Plymouth
country: United States
facility: Michiana Hematology Oncology PC - Plymouth
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Westville
country: United States
facility: Michiana Hematology Oncology PC - La Porte
state: Indiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders - Scarborough
state: Maine
city: Baltimore
country: United States
facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
state: Maryland
city: Attleboro
country: United States
facility: Sturdy Memorial Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
state: Massachusetts
city: Gloucester
country: United States
facility: Addison Gilbert Hospital
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
city: Battle Creek
country: United States
facility: Battle Creek Health System Cancer Care Center
state: Michigan
city: Big Rapids
country: United States
facility: Mecosta County Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Butterworth Hospital at Spectrum Health
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Grand Rapids
country: United States
facility: Lacks Cancer Center at Saint Mary's Health Care
state: Michigan
city: Muskegon
country: United States
facility: Mercy General Health Partners
state: Michigan
city: Niles
country: United States
facility: Michiana Hematology Oncology PC - Niles
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Regional Cancer Care Center - St. Joseph
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeside Cancer Specialists, PLLC
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Chesterfield
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: St. Anthony's Cancer Center
state: Missouri
city: Grand Island
country: United States
facility: Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
state: Nebraska
city: North Platte
country: United States
facility: Callahan Cancer Center at Great Plains Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: UNMC Eppley Cancer Center at the University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: Concord
country: United States
facility: New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
state: New Hampshire
city: Exeter
country: United States
facility: Center for Cancer Care at Exeter Hospital
state: New Hampshire
city: Hooksett
country: United States
facility: New Hampshire Oncology - Hematology, PA - Hooksett
state: New Hampshire
city: Laconia
country: United States
facility: Lakes Region General Hospital
state: New Hampshire
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Norris Cotton Cancer Center at Catholic Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Regional Cancer Center at Elliot Hospital
state: New Hampshire
city: Nashua
country: United States
facility: Foundation Medical Partners
state: New Hampshire
city: Nashua
country: United States
facility: Oncology Center at St. Joseph Hospital
state: New Hampshire
city: Livingston
country: United States
facility: St. Barnabas Medical Center Cancer Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: Lipson Cancer and Blood Center at Rochester General Hospital
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Fayetteville
country: United States
facility: Cape Fear Valley Medical Center Cancer Center
state: North Carolina
city: Henderson
country: United States
facility: Maria Parham Medical Center
state: North Carolina
city: Lumberton
country: United States
facility: Southeastern Regional Medical Center
state: North Carolina
city: Oxford
country: United States
facility: Granville Medical Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Health Raleigh Hospital
state: North Carolina
city: Roxboro
country: United States
facility: Person Memorial Hospital
state: North Carolina
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center at Beaufort County Hospital
state: North Carolina
city: Beaufort
country: United States
facility: Keyserling Cancer Center at Beaufort Memorial Hospital
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Myrtle Beach
country: United States
facility: Coastal Cancer Center - Myrtle Beach
state: South Carolina
city: Berlin Corners
country: United States
facility: Mountainview Medical
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Health Care - University Health Center Campus
state: Vermont
city: Fairfax
country: United States
facility: Medical Oncology and Hematology Associates of North Virginia - Fairfax
state: Virginia
city: Huntington
country: United States
facility: St. Mary's Regional Cancer Center at St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Jeanne Mandelblatt, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.
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 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.
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.
citation: 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.
citation: 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.
citation: 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.