Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance
- Conditions
- Cognitive/Functional EffectsPsychosocial Effects of Cancer and Its TreatmentSpiritual ConcernsCancer SurvivorSexuality and Reproductive IssuesBreast Cancer
- Registration Number
- NCT00309933
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2697
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the quality of life of partners Comparison of the quality of life Comparison of quality of life models Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (104)
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
North Coast Cancer Care - Clyde
🇺🇸Clyde, Ohio, United States
Marshfield Clinic - Wausau Center
🇺🇸Wausau, Wisconsin, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Canton, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Marshfield Clinic - Lakeland Center
🇺🇸Minocqua, Wisconsin, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
Mercy Regional Cancer Center
🇺🇸Janesville, Wisconsin, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
🇺🇸Oconomowoc, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
🇺🇸Rhinelander, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
MBCCOP - Meharry Medical College - Nashville
🇺🇸Nashville, Tennessee, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
🇺🇸Monterey, California, United States
Manchester Memorial Hospital
🇺🇸Manchester, Connecticut, United States
Hematology and Oncology Associates
🇺🇸Chicago, Illinois, United States
Hematology Oncology Associates of Illinois - Berwyn
🇺🇸Berwyn, Illinois, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
🇺🇸Libertyville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
🇺🇸Niles, Illinois, United States
La Grange Oncology Associates - Geneva
🇺🇸Naperville, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Hematology Oncology Associates - Skokie
🇺🇸Skokie, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Clarian Arnett Cancer Care
🇺🇸Lafayette, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
York Hospital's Oncology Treatment Center
🇺🇸York, Maine, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸Hamilton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
🇺🇸Voorhees, New Jersey, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
St. Anne Mercy Hospital
🇺🇸Toledo, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Cancer Center at Phoenixville Hospital
🇺🇸Phoenixville, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
🇺🇸Sayre, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Marshfield Clinic - Chippewa Center
🇺🇸Chippewa Falls, Wisconsin, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States