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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00309933
First received: March 29, 2006
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Quality of Life in Younger Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of the quality of life [ Designated as safety issue: No ]
  • Comparison of the quality of life of partners [ Designated as safety issue: No ]
  • Comparison of quality of life models [ Designated as safety issue: No ]
  • Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables [ Designated as safety issue: No ]

Estimated Enrollment: 2697
Study Start Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309933

  Show 104 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Victoria Champion, DNS Indiana University Melvin and Bren Simon Cancer Center
Investigator: George W. Sledge, MD Indiana University Melvin and Bren Simon Cancer Center
Investigator: Lynne Wagner, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00309933     History of Changes
Other Study ID Numbers: CDR0000460234, ECOG-E2Z04
Study First Received: March 29, 2006
Last Updated: March 9, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014