Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance
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|ClinicalTrials.gov Identifier: NCT00309933|
Recruitment Status : Unknown
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 3, 2006
Last Update Posted : March 10, 2010
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 or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||2697 participants|
|Official Title:||Quality of Life in Younger Breast Cancer Survivors|
|Study Start Date :||October 2005|
- Comparison of the quality of life
- Comparison of the quality of life of partners
- Comparison of quality of life models
- Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309933
Show 104 Study Locations
|Study Chair:||Victoria Champion, DNS||Indiana University Melvin and Bren Simon Cancer Center|
|OverallOfficial:||George W. Sledge, MD||Indiana University Melvin and Bren Simon Cancer Center|
|OverallOfficial:||Lynne Wagner, MD||Robert H. Lurie Cancer Center|