跳至主要内容
临床试验/NCT00309933
NCT00309933已完成不适用

Quality of Life in Younger Breast Cancer Survivors

Eastern Cooperative Oncology Group104 个研究点 分布在 1 个国家目标入组 2,697 人开始时间: 2006年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,697
试验地点
104
主要终点
Comparison of quality of life models

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Comparison of quality of life models

Comparison of the quality of life of partners

Comparison of the quality of life

Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (104)

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