AzTrials
AzTrials

Breast CancerNCT00309933

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

An observational study of Breast Cancer and Cancer Survivor, run by Eastern Cooperative Oncology Group at 104 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 78 years, women only
What is being tested?
cognitive assessment, psychosocial assessment and care and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
2,697 participants
Where
104 sitesUnited States
Study dates
3 Apr 2006to Mar 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

104 sites in 1 country.

104 sites in 1 country

United States104 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Hematology Oncology Associates of Illinois - Berwyn

    Berwyn, Illinois, 60402

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Mercy Regional Cancer Center

    Janesville, Wisconsin, 53547

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Clarian Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Manchester Memorial Hospital

    Manchester, Connecticut, 06040

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

    Monterey, California, 93940

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • La Grange Oncology Associates - Geneva

    Naperville, Illinois, 60563

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Jersey Shore Cancer Center at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754-0397

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Cancer Center at Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Guthrie Cancer Center at Guthrie Clinic Sayre

    Sayre, Pennsylvania, 18840

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Marshfield Clinic at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Marshfield Clinic - Wausau Center

    Wausau, Wisconsin, 54401

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • CCOP - Main Line Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • York Hospital's Oncology Treatment Center

    York Village, Maine, 03909

Other trials in United States

About this study

Official title: Quality of Life in Younger Breast Cancer Survivors

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.

Read the 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.

Being tested
cognitive assessment, psychosocial assessment and care, quality-of-life assessment
Keywords
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
Medical subject headings
Breast Neoplasms, Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive assessmentProcedure or surgery

  • psychosocial assessment and careProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2006 (estimated)
  2. Study start3 Apr 2006
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
2,697 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309933
Sponsor's protocol ID
CDR0000460234
Other IDs
ECOG-E2Z04
Status last verified
Jun 2023
First submitted
29 Mar 2006
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Cancer Survivor, run by Eastern Cooperative Oncology Group at 104 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the quality of life. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00309933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in