Overview

This trial is active, not recruiting.

Conditions breast cancer, cancer survivor, cognitive/functional effects, psychosocial effects of cancer and its treatment, sexuality and reproductive issues, spiritual concerns
Treatments cognitive assessment, psychosocial assessment and care, quality-of-life assessment
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date October 2005
Trial size 2697 participants
Trial identifier NCT00309933, CDR0000460234, ECOG-E2Z04

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.

PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors and their spouse, partner, or acquaintance.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Comparison of the quality of life
time frame:
Comparison of the quality of life of partners
time frame:
Comparison of quality of life models
time frame:
Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables
time frame:

Eligibility Criteria

Female participants from 18 years up to 78 years old.

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

Additional Information

Official title Quality of Life in Younger Breast Cancer Survivors
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).