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临床试验/NCT03364673
NCT03364673已完成不适用

Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer

Dana-Farber Cancer Institute2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年7月20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
29
试验地点
2
主要终点
Feasibility of the Accelerometer + Social Support + Gamification

研究概览

简要总结

This research study will test whether using wearable fitness trackers with a social incentive, delivered through a game-based mobile health intervention, increases physical activity and quality of life in ovarian cancer survivors.

详细描述

Nearly 50% of ovarian cancer survivors experience poor quality of life, fatigue, and anxiety after completing surgery and chemotherapy to treat their disease. Moreover, many ovarian cancer survivors become deconditioned during treatment; 40% report significant drops in activity during the year after diagnosis, and only 20% meet the recommended guidelines for physical activity.

Interventional exercise studies are urgently needed to determine whether increasing physical activity improves outcomes in ovarian cancer survivors. In other cancers, physical activity improves quality of life and mental health, while reducing the risk of cancer recurrence and death. To date, however, most studies have focused on patients with curable breast and prostate cancers. The effects of physical activity on understudied populations, including ovarian cancer survivors, are unknown. Furthermore, although ovarian cancer survivors report an interest in participating in home-based walking programs, few formal programs exist.

Stepping into Survivorship is a single-arm study designed to test the effectiveness of a wearable fitness tracker with a game-based mobile health intervention that leverages social support to increase physical activity in ovarian cancer survivors. At the start of the study all participants will track their daily step counts using a wearable fitness tracker (e.g. Fitbit) to determine how many steps they walk in an average day. Next, they will set an increased step-goal and receive daily, individualized feedback based upon their performance.

Participants will also choose a team partner (i.e. family or friend) to receive a wearable fitness tracker and together they will track their steps, earning non-financial micro-incentives (e.g. points, levels, badges) when they achieve their collaborative goals. This game-based mobile health intervention is designed to enhance collaboration, accountability, peer support, and ultimately physical activity among ovarian cancer survivors and their friends/family members.

This research is being done to improve participants' quality of life. The investigators hope that the use of wearable fitness trackers with a game-based mobile health intervention will help participants increase their physical activity and improve quality of life.

研究设计

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

入排标准

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

入选标准

  • Patients will be eligible if they have newly diagnosed ovarian cancer
  • Are ≤6 months of completing chemotherapy
  • Read English
  • Do not have cognitive, visual, or orthopedic impairments that would preclude participation
  • Plan to continue treatment at Dana-Farber Cancer Institute

排除标准

  • Participants will be excluded if they are already participating in an mHealth intervention
  • Are unable to ambulate
  • Do not have a smartphone to transmit data from the wearable tracker

结局指标

主要结局

Feasibility of the Accelerometer + Social Support + Gamification

时间窗: 1 year pilot

Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention

Acceptability

时间窗: 24 weeks

Study burden: To what extent do you agree or disagree with: "Participating in this study placed a substantial burden on me." (Options: strongly agree, agree, neutral, disagree, strongly disagree)

Perceived Effectiveness

时间窗: 24 weeks

To what extent do you agree or disagree with the following statements: "Participating in this study motivated me to increase my activity levels." Response options: strongly disagree, disagree, neutral, agree, strongly agree.

次要结局

  • Change in Daily Steps From Baseline 24 Weeks(24 weeks [from end to baseline (day 15) to day 182])
  • Change in Daily Steps From Baseline to 12 Weeks(12 weeks [from end of baseline (day 15) to day 98])

研究者

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

Alexi A. Wright, MD

Prinicipal Investigator

Dana-Farber Cancer Institute

研究点 (2)

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