NCT Number: NCT00309933
Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance
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.
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Notify MeKey information
Conditions
Age range
18 year–78 year
Sex eligibility
Female
Study type
Observational
Primary location
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center, Monterey, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
psychosocial assessment and care
Procedurequality-of-life assessment
ProcedurePrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Eastern Cooperative Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Quality of Life in Younger Breast Cancer Survivors
Important dates
- Study start
- 2006
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Apr 3, 2006
- Registry last updated
- Jun 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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