跳至主要内容
临床试验/NCT02694640
NCT02694640已完成不适用

Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

University of South Carolina2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2016年1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
161
试验地点
2
主要终点
Physical Activity

研究概览

简要总结

Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained American Cancer Society volunteers to provide exercise counseling to breast cancer survivors and the survivors increased their exercise in the short-term. This RCT examines the effects of three maintenance conditions on survivors' exercise participation at longer follow-ups. The cost-effectiveness of the three groups will be examined to guide implementation of this peer mentoring approach in community-based organizations.

详细描述

The current study, a randomized controlled trial (RCT), represents the next step of the efforts to to extend the research on physical activity to the community setting; community volunteers will deliver the intervention, thereby making physical activity interventions much more accessible to survivors. In partnership with the National American Cancer Society office (Atlanta, GA) and Reach To Recovery (RTR) programs in North Carolina, South Carolina, and Georgia, researchers at the University of South Carolina's College of Nursing will share skills, experience and resources to examine the effects of RTR coaches offering a theoretically-based 3-month exercise program among 150 breast cancer survivors to increase moderate-to-vigorous physical activity (MVPA) followed by self-monitoring (i.e. exercise logs) and feedback reports in Months 4-9 (Reach Plus), monthly phone calls from RTR coaches, self monitoring and feedback reports in Months 4-9 (Reach Plus Message) or weekly email/text messages, self-monitoring and feedback reports in Months 4-9 (Reach Plus Message). In this three group study, researchers will assess survivors' exercise, fatigue, mood, quality of life, and self-reported physical functioning at baseline, 3, 9 and 12 months. The costs of the methods vary and data on costs will be collected to guide the selection of maintenance strategies for dissemination. If the results are promising, researchers will proceed with a dissemination trial wherein the large network of RTR volunteers can expand the scope of their services to benefit breast cancer survivors.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Women aged 21 years or over will be eligible if they:
  • Have been diagnosed in the past 5 years with Stage 0-3 breast cancer.
  • Are able to read and speak English.
  • Are ambulatory.
  • Are sedentary (i.e., do not meet recommendations for moderate-intensity PA [30 minutes/ day or more for at least 5 days/ week] or vigorous-intensity PA [20 minutes/day or more for at least 3 days/week]
  • Are able to walk unassisted.
  • Have access to a telephone.

排除标准

  • Women with:
  • More advanced disease (Stage 4).
  • Medical or psychiatric problems (e.g., substance abuse, coronary artery disease, peripheral vascular disease, diabetes, and orthopedic problems) that may interfere with protocol adherence will not be included.
  • Participants will be asked to provide consent for medical chart review to extract disease and treatment variables. Eligible participants will obtain medical clearance from their physicians.

结局指标

主要结局

Physical Activity

时间窗: 9 and 12 months

Through interviewer - administered Seven Day Activity Recall

Min/Week Objectively Measured Moderate-to-vigorous Physical Activity

时间窗: 9 and 12 months

Minutes per week of at least moderate intensity activity as measured by accelerometer (GT3X)

次要结局

  • Fatigue(Score at 9 and 12 months)
  • Mood(Score at 9 and 12 months)
  • Breast Cancer Quality of Life(Change at 9 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernardine Pinto

Associate Dean

University of South Carolina

研究点 (2)

Loading locations...

相似试验