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临床试验/NCT02781051
NCT02781051已完成不适用

Increasing Physical Activity Among Breast Cancer Survivors With Depression

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer

研究概览

简要总结

Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

详细描述

The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Positive depression screen (PHQ-9) or current antidepressant treatment
  • Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ
  • Physically able to engage in physical activity
  • Written and verbal fluency in English

排除标准

  • Medical condition contraindicating physical activity participation
  • Recurrence of breast cancer
  • Ductal carcinoma in situ (DCIS) diagnosis
  • Cognitively unable to give informed consent
  • Non-English speaking

研究组 & 干预措施

Physical Activity Intervention

Experimental

Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

干预措施: Print-based education (Behavioral)

Physical Activity Intervention

Experimental

Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

干预措施: Fitbit (Device)

Physical Activity Intervention

Experimental

Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

干预措施: Active Living counseling (Behavioral)

Physical Activity Intervention

Experimental

Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

干预措施: Facility Access (Other)

结局指标

主要结局

Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer

时间窗: 6 months

Assess changes in physical activity at 6 months following physical activity intervention.

次要结局

  • Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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