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

Breast Cancer Clinical Trial

Official title:

Quality of Life in Younger Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309933
• Other study ID #: CDR0000460234
• Secondary ID: ECOG-E2Z04
• Status: Completed
• Start date: April 3, 2006
• Est. completion date: March 2011

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2697
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Cognitive/Functional Effects
• Psychosocial Effects of Cancer and Its Treatment
• Sexuality and Reproductive Issues
• Spiritual Concerns

Intervention

Procedure:
• cognitive assessment

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	McFarland Clinic, PC	Ames	Iowa
United States	Hematology Oncology Associates of Illinois - Berwyn	Berwyn	Illinois
United States	Suburban Hospital	Bethesda	Maryland
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Marshfield Clinic - Chippewa Center	Chippewa Falls	Wisconsin
United States	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	North Coast Cancer Care - Clyde	Clyde	Ohio
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Hematology Oncology Center	Elyria	Ohio
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	Evanston Hospital	Evanston	Illinois
United States	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Dickinson County Healthcare System	Iron Mountain	Michigan
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Mercy Regional Cancer Center	Janesville	Wisconsin
United States	Midwest Center for Hematology/Oncology	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Howard Community Hospital	Kokomo	Indiana
United States	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Clarian Arnett Cancer Care	Lafayette	Indiana
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois
United States	Lima Memorial Hospital	Lima	Ohio
United States	Manchester Memorial Hospital	Manchester	Connecticut
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	Community Hospital of the Monterey Peninsula Comprehensive Cancer Center	Monterey	California
United States	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia
United States	La Grange Oncology Associates - Geneva	Naperville	Illinois
United States	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee
United States	Jersey Shore Cancer Center at Jersey Shore University Medical Center	Neptune	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois
United States	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Cancer Center at Phoenixville Hospital	Phoenixville	Pennsylvania
United States	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin
United States	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	Marshfield Clinic - Wausau Center	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	York Hospital's Oncology Treatment Center	York	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the quality of life
Primary	Comparison of the quality of life of partners
Primary	Comparison of quality of life models
Primary	Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables