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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00068328

Collaborator

National Cancer Institute (NCI) (NIH)

1,706

Enrollment

Locations

160

Duration (Months)

20.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Psychosocial Effects of Cancer and Its Treatment	Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1706 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

quality of life [Up to 5 years]

Secondary Outcome Measures

disease free survival [Up to 5 years]
mortality rate [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Camino Medical Group - Treatment Center	Mountain View	California	United States	94040
2	Palo Alto Medical Foundation	Palo Alto	California	United States	94301
3		Pismo Beach	California	United States	93449
4	Bendheim Cancer Center at Greenwich Hospital	Greenwich	Connecticut	United States	06830
5	Washington Cancer Institute at Washington Hospital Center	Washington, D.C.	District of Columbia	United States	20010
6	Walter Reed Army Medical Center	Washington, D.C.	District of Columbia	United States	20307-5001
7	Cancer Center of South Florida Foundation, Incorporated	Lake Worth	Florida	United States	33461
8	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
9	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
10	La Grange Memorial Hospital	La Grange	Illinois	United States	60525
11	Center for Cancer Care at OSF Saint Anthony Medical Center	Rockford	Illinois	United States	61108
12	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
13	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
14	Elkhart General Hospital	Elkhart	Indiana	United States	46515
15	Howard Community Hospital	Kokomo	Indiana	United States	46904
16	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
17	Suniti Medical Corporation	Merrillville	Indiana	United States	46410
18	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
19	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
20	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
21	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
22	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
23	South Bend Clinic	South Bend	Indiana	United States	46617
24	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
25	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine	United States	04074
26	Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Baltimore	Maryland	United States	21237
27	Sturdy Memorial Hospital	Attleboro	Massachusetts	United States	02703
28	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
29	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts	United States	02115
30	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
31	Addison Gilbert Hospital	Gloucester	Massachusetts	United States	01930
32	Cape Cod Hospital	Hyannis	Massachusetts	United States	02601
33	Lowell General Hospital	Lowell	Massachusetts	United States	01854
34	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
35	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
36	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
37	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
38	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
39	Mercy General Health Partners	Muskegon	Michigan	United States	49443
40	Michiana Hematology Oncology PC - Niles	Niles	Michigan	United States	49120
41	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
42	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
43	Munson Medical Center	Traverse City	Michigan	United States	49684
44	Metro Health Hospital	Wyoming	Michigan	United States	49519
45	Saint Luke's Hospital	Chesterfield	Missouri	United States	63017
46	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
47	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
48	St. Anthony's Cancer Center	Saint Louis	Missouri	United States	63128
49	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center	Grand Island	Nebraska	United States	68803
50	Callahan Cancer Center at Great Plains Regional Medical Center	North Platte	Nebraska	United States	69103
51	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-6805
52	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
53	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
54	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire	United States	03301
55	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire	United States	03833
56	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
57	Lakes Region General Hospital	Laconia	New Hampshire	United States	03246
58	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
59	Norris Cotton Cancer Center at Catholic Medical Center	Manchester	New Hampshire	United States	03102
60	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire	United States	03103
61	Foundation Medical Partners	Nashua	New Hampshire	United States	03060
62	Oncology Center at St. Joseph Hospital	Nashua	New Hampshire	United States	03060
63	St. Barnabas Medical Center Cancer Center	Livingston	New Jersey	United States	07039
64	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
65	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
66	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
67	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
68	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York	United States	14621
69	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
70	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
71	Cape Fear Valley Medical Center Cancer Center	Fayetteville	North Carolina	United States	28302-2000
72	Maria Parham Medical Center	Henderson	North Carolina	United States	27536
73	Southeastern Regional Medical Center	Lumberton	North Carolina	United States	28359
74	Granville Medical Center	Oxford	North Carolina	United States	27565
75	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina	United States	28374
76	Duke Health Raleigh Hospital	Raleigh	North Carolina	United States	27609
77	Person Memorial Hospital	Roxboro	North Carolina	United States	27573
78	Marion L. Shepard Cancer Center at Beaufort County Hospital	Washington	North Carolina	United States	27889
79	Keyserling Cancer Center at Beaufort Memorial Hospital	Beaufort	South Carolina	United States	29902
80	South Carolina Oncology Associates, PA	Columbia	South Carolina	United States	29210
81	Coastal Cancer Center - Myrtle Beach	Myrtle Beach	South Carolina	United States	29572
82	Mountainview Medical	Berlin Corners	Vermont	United States	05602
83	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
84	Medical Oncology and Hematology Associates of North Virginia - Fairfax	Fairfax	Virginia	United States	22031
85	St. Mary's Regional Cancer Center at St. Mary's Medical Center	Huntington	West Virginia	United States	25702