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临床试验/NCT01819324
NCT01819324已完成不适用

Targeting the Teachable Moment: A Lifestyle Intervention for Breast Cancer Survivors

Hartford Hospital2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
2
主要终点
Changes in eating habits measured by the National Cancer Institute Quick Food Scan

研究概览

简要总结

  1. The purpose of the study is to test the effectiveness of a new mail-based intervention for breast cancer survivors compared with standard lifestyle management and no-treatment.
  2. This intervention addresses both lifestyle factors such as dietary and physical activities and psychological issues specific to breast cancer survivors to improve healthy behaviors.

详细描述

Participants will be assigned randomly to one of three groups: 1) newly developed mail-based intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however TTMI additionally addresses psychosocial issues specific to breast cancer survivors.

All participants will complete questionnaires at the time they start the study, the end of the 4 months, and 3 months later for a follow-up.

If participants are assigned to any of the intervention group, they will receive materials every other week for 4 months. If participants are assigned to the usual care group, they will receive the same materials as the standard lifestyle intervention et the end of the 7 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • First diagnosed with breast cancer in the past 1.5 years
  • stage 0~2 breast cancer
  • no prior adjuvant treatment for another cancer
  • Can read and write English
  • Are not participating in other health behavior research right now

排除标准

  • apparent serious mental disturbance
  • male breast cancer survivors

结局指标

主要结局

Changes in eating habits measured by the National Cancer Institute Quick Food Scan

时间窗: Meaured at baseline, 4 months, and 7 months

Diet habits (amount of fat and fruit/vegetable uptake) will be assessed at 3 times: at baseline, at the end of the 4 months, and at the end of 7 months.

Changes in physical activity measured by the Paffenbarger physical activity questionnaire

时间窗: Meaured at baseline, 4 months, and 7 months

Frequency and amount of time for physical exercise will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months.

次要结局

  • Changes in coping strategies measured by the Brief COPE(Measured at baseline, 4 months, and 7 months)
  • Changes in Self-efficacy measured by the General Self-Efficacy Scale(Measured at baseline, 4 months, and 7 months)
  • Changes in social support measured by the Interpersonal Support Evaluation List (ISEL)(Measured at baseline, 4 months, and 7 months)
  • Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ)(Measured at baseline, 4 months, and 7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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