Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance
NCT ID: NCT00309933
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2697 participants
OBSERVATIONAL
2006-04-03
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors and their spouse, partner, or acquaintance.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
NCT00268502
Support Group Program in Improving Quality of Life in Underserved Urban Latina Breast Cancer Survivors
NCT02521961
Psychosocial Treatment for Improving Chances of Survival in Women With Breast Cancer
NCT00226928
Couples-Based Mindfulness for Young Breast Cancer Survivors
NCT02840344
Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients
NCT00582478
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cognitive assessment
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
78 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Victoria Champion, DNS
Role: STUDY_CHAIR
Indiana University Melvin and Bren Simon Cancer Center
George W. Sledge, MD
Role:
Indiana University Melvin and Bren Simon Cancer Center
Lynne Wagner, MD
Role:
Robert H. Lurie Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
Monterey, California, United States
Manchester Memorial Hospital
Manchester, Connecticut, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, 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
La Grange Oncology Associates - Geneva
Naperville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, 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
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
McFarland Clinic, PC
Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
York Hospital's Oncology Treatment Center
York Village, Maine, United States
Suburban Hospital
Bethesda, Maryland, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 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 City, 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 Township, New Jersey, United States
Wood County Oncology Center
Bowling Green, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
North Coast Cancer Care - Clyde
Clyde, Ohio, United States
Hematology Oncology Center
Elyria, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Toledo Clinic - Oregon
Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 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
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
St. Anne Mercy Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 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
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 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
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 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
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Mercy Regional Cancer Center
Janesville, 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 - Marshfield Center
Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 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
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ECOG-E2Z04
Identifier Type: -
Identifier Source: secondary_id
CDR0000460234
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.