Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00309933
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 2,697
• Locations: 104
• Actual Duration (Months): 65
• Patients Per Site: 25.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

RATIONALE: Studying quality of life in breast cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future breast cancer survivors.

PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors and their spouse, partner, or acquaintance.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Cancer Survivor; Cognitive/Functional Effects; Psychosocial Effects of Cancer and Its Treatment; Sexuality and Reproductive Issues; Spiritual Concerns	Procedure: cognitive assessment; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

Detailed Description

OBJECTIVES:

• Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of female breast cancer survivors who were age 45 or younger at the time of diagnosis with the quality of life of female breast cancer survivors who were age 55 to 70 at time of diagnosis (considering type of surgical treatment [lumpectomy vs mastectomy], hormonal treatments, and time since diagnosis as covariates) and age-matched (to the younger group) females with no history of breast cancer.

• Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of partners of breast cancer survivors who were age 45 or younger at time of diagnosis with the quality of life of partners of breast cancer survivors who were age 55 to 70 at diagnosis and partners of age-matched (to the younger group) females with no history of breast cancer.

• Test and compare quality of life models that identify the variables that mediate between antecedent variables of personal characteristics, diagnostic and treatment characteristics, and quality of life outcomes in order to determine where interventions to improve quality of life should be targeted.

• Explore the relationship of partner antecedent, mediating, and outcome variables as predictors or mediators of outcome variables for breast cancer survivors.

OUTLINE: This is a multicenter study.

Patients, spouse or partner of patients, age-matched acquaintances of patients, and partner of acquaintances complete questionnaires over 60-90 minutes about personal characteristics, self-efficacy, coping, social support, health care provider communication, physical, psychological, social, and spiritual functioning, and quality of life. After completing the study questionnaires, patients and age-matched acquaintances of patients are interviewed via telephone over 30 minutes for cognitive function assessment. A random subset of patients and spouses/partners of patients are interviewed via telephone over 45-60 minutes, using data-generating and open-ended questions, regarding physical functioning, sexual and reproductive issues, psychological issues, social impact, and methods used to deal with breast cancer survivor concerns.

Disease and treatment characteristics of patients are obtained from medical records.

PROJECTED ACCRUAL: A total of 2,697 patients, spouse or partner of patients, age-matched female acquaintances of patients, and partner of acquaintances will be accrued for this study.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2697 participants
• Official Title: Quality of Life in Younger Breast Cancer Survivors
• Actual Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Outcome Measures

Primary Outcome Measures

1. Comparison of the quality of life []

2. Comparison of the quality of life of partners []

3. Comparison of quality of life models []

4. Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Patient

• Female breast cancer survivor with age at initial diagnosis in 1 of the following ranges:

• 18 to 45

• 55 to 78

• Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197

• Must have received chemotherapy at least 3 years, but no more than 8 years prior to this study entry

• Disease free at the time of this study entry

• Spouse or partner of the patient, age-matched female acquaintances of the patient (in the younger patient group), or partner of acquaintances

• Spouse or partner of the patient may be either gender

• Age-matched female acquaintance is defined as within 5 years of age difference of the patient in younger group (18-45 years of age)

• With a similar level of education and race of the patient

• Not a personal friend of the patient

• No history of breast cancer

PATIENT CHARACTERISTICS:

• Must reside in the continental U.S. and speak English (for patients)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Hospital of the Monterey Peninsula Comprehensive Cancer Center	Monterey	California	United States	93940
2	Manchester Memorial Hospital	Manchester	Connecticut	United States	06040
3	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida	United States	32207
4	Hematology Oncology Associates of Illinois - Berwyn	Berwyn	Illinois	United States	60402
5	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
6	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
9	Evanston Hospital	Evanston	Illinois	United States	60201-1781
10	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
11	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
12	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
13	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
14	La Grange Oncology Associates - Geneva	Naperville	Illinois	United States	60563
15	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois	United States	60714
16	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
17	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
18	Elkhart General Hospital	Elkhart	Indiana	United States	46515
19	Howard Community Hospital	Kokomo	Indiana	United States	46904
20	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
21	Clarian Arnett Cancer Care	Lafayette	Indiana	United States	47904
22	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
23	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
24	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
25	South Bend Clinic	South Bend	Indiana	United States	46617
26	McFarland Clinic, PC	Ames	Iowa	United States	50010
27	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
28	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
29	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
30	York Hospital's Oncology Treatment Center	York	Maine	United States	03909
31	Suburban Hospital	Bethesda	Maryland	United States	20814
32	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
33	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
34	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
35	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
36	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
37	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
38	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
39	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
40	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
41	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
42	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
43	CCOP - Duluth	Duluth	Minnesota	United States	55805
44	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
45	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
46	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
47	Jersey Shore Cancer Center at Jersey Shore University Medical Center	Neptune	New Jersey	United States	07754-0397
48	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
49	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
50	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
51	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio	United States	44708
52	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
53	North Coast Cancer Care - Clyde	Clyde	Ohio	United States	43410
54	Hematology Oncology Center	Elyria	Ohio	United States	44035
55	Lima Memorial Hospital	Lima	Ohio	United States	45804
56	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
57	St. Luke's Hospital	Maumee	Ohio	United States	43537
58	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
59	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
60	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
61	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
62	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
63	Toledo Hospital	Toledo	Ohio	United States	43606
64	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
65	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
66	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
67	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
68	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
69	Fulton County Health Center	Wauseon	Ohio	United States	43567
70	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
71	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17604
72	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
73	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
74	Cancer Center at Phoenixville Hospital	Phoenixville	Pennsylvania	United States	19460
75	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania	United States	18840
76	CCOP - Main Line Health	Wynnewood	Pennsylvania	United States	19096
77	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
78	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
79	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
80	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee	United States	37208-3599
81	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
82	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
83	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia	United States	26506
84	Marshfield Clinic - Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
85	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
86	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
87	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
88	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
89	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
90	Mercy Regional Cancer Center	Janesville	Wisconsin	United States	53547
91	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin	United States	54601
92	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
93	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
94	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
95	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
96	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
97	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
98	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
99	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
100	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
101	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin	United States	53188
102	Marshfield Clinic - Wausau Center	Wausau	Wisconsin	United States	54401
103	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
104	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494

Sponsors and Collaborators

• Eastern Cooperative Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Victoria Champion, DNS, Indiana University Melvin and Bren Simon Cancer Center
• : George W. Sledge, MD, Indiana University Melvin and Bren Simon Cancer Center
• : Lynne Wagner, MD, Robert H. Lurie Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00309933
• Other Study ID Numbers: CDR0000460234; ECOG-E2Z04
• First Posted: Apr 3, 2006
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eastern Cooperative Oncology Group: cognitive/functional effects; spiritual concerns; sexuality and reproductive issues; psychosocial effects of cancer and its treatment; cancer survivor; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 10, 2022