Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-369901 | |||
| CDR0000321396 | Registry Identifier | NCI Physician Data Query |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psychosocial assessment and care | Procedure |
| ||
| quality-of-life assessment |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | Up to 5 years | |
| mortality rate | Up to 5 years |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the breast
No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Other
Not provided
Not provided
Not provided
Women aged 65 years and older diagnosed with adenocarcinoma of the breast.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeanne Mandelblatt, MD, MPH | Lombardi Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camino Medical Group - Treatment Center | Mountain View | California | 94040 | United States | ||
| Palo Alto Medical Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22614985 | Result | 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. | |
| 20516438 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| Palo Alto |
| California |
| 94301 |
| United States |
| Pismo Beach | California | 93449 | United States |
| Bendheim Cancer Center at Greenwich Hospital | Greenwich | Connecticut | 06830 | United States |
| Washington Cancer Institute at Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| Cancer Center of South Florida Foundation, Incorporated | Lake Worth | Florida | 33461 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| La Grange Memorial Hospital | La Grange | Illinois | 60525 | United States |
| Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Elkhart Clinic, LLC | Elkhart | Indiana | 46514-2098 | United States |
| Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana | 46514 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Suniti Medical Corporation | Merrillville | Indiana | 46410 | United States |
| Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana | 46545-1470 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545-1470 | United States |
| Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana | 46563 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Michiana Hematology Oncology PC - La Porte | Westville | Indiana | 46391 | United States |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | 04074 | United States |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| Sturdy Memorial Hospital | Attleboro | Massachusetts | 02703 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Addison Gilbert Hospital | Gloucester | Massachusetts | 01930 | United States |
| Cape Cod Hospital | Hyannis | Massachusetts | 02601 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Mercy General Health Partners | Muskegon | Michigan | 49443 | United States |
| Michiana Hematology Oncology PC - Niles | Niles | Michigan | 49120 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan | 49085 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| St. Anthony's Cancer Center | St Louis | Missouri | 63128 | United States |
| Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island | Nebraska | 68803 | United States |
| Callahan Cancer Center at Great Plains Regional Medical Center | North Platte | Nebraska | 69103 | United States |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| Center for Cancer Care at Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Norris Cotton Cancer Center at Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Elliot Regional Cancer Center at Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Foundation Medical Partners | Nashua | New Hampshire | 03060 | United States |
| Oncology Center at St. Joseph Hospital | Nashua | New Hampshire | 03060 | United States |
| St. Barnabas Medical Center Cancer Center | Livingston | New Jersey | 07039 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Lipson Cancer and Blood Center at Rochester General Hospital | Rochester | New York | 14621 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Cape Fear Valley Medical Center Cancer Center | Fayetteville | North Carolina | 28302-2000 | United States |
| Maria Parham Medical Center | Henderson | North Carolina | 27536 | United States |
| Southeastern Regional Medical Center | Lumberton | North Carolina | 28359 | United States |
| Granville Medical Center | Oxford | North Carolina | 27565 | United States |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| Duke Health Raleigh Hospital | Raleigh | North Carolina | 27609 | United States |
| Person Memorial Hospital | Roxboro | North Carolina | 27573 | United States |
| Marion L. Shepard Cancer Center at Beaufort County Hospital | Washington | North Carolina | 27889 | United States |
| Keyserling Cancer Center at Beaufort Memorial Hospital | Beaufort | South Carolina | 29902 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| Coastal Cancer Center - Myrtle Beach | Myrtle Beach | South Carolina | 29572 | United States |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Medical Oncology and Hematology Associates of North Virginia - Fairfax | Fairfax | Virginia | 22031 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| 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. |
| 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. |
| 16598833 | 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. |
| 28653250 | Derived | 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. |
| 28364214 | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided