跳至主要内容
临床试验/NCT04266080
NCT04266080
进行中(未招募)
不适用

Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 48 人2020年2月7日

概览

阶段
不适用
干预措施
Fitbit Inspire HR
疾病 / 适应症
Survivors of Childhood Cancer
发起方
Memorial Sloan Kettering Cancer Center
入组人数
48
试验地点
1
主要终点
Acceptability of the intervention
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

This study will test whether a game-based exercise plan can help increase the level of physical activity in childhood cancer survivors. The game-based exercise plan will involve participation by both a childhood cancer survivor and his/her parent or caregiver. This study will also look at whether the game-based exercise plan improves childhood cancer survivors' quality of life.

注册库
clinicaltrials.gov
开始日期
2020年2月7日
结束日期
2027年2月1日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Childhood cancer survivor:
  • History of treatment for childhood cancer with cardiotoxic therapy (anthracyclines, chest radiation, total body irradiation)
  • Off all systemic cancer therapy for ≥ 2 years
  • Ability to speak and understand English
  • Ability to complete all protocol assessments
  • Mobile device with SMS text messaging capability
  • Ambulatory and able to perform all study requirements
  • Attained age 10-16 years
  • Has a parent or legal guardian willing to participate in the study as a dyad
  • Willing to receive daily SMS text message alerts

排除标准

  • Survivors, or parents/legal guardians of survivors, with a medical condition that makes it unsafe to complete study requirements are not eligible for this study. This includes a diagnosis of:
  • Severe persistent asthma
  • Known symptomatic coronary artery disease
  • Musculoskeletal defects that interfere with sustained physical activity
  • Any medical or psychosocial condition that, in the opinion of the investigator, would jeopardize the health of the participant during study procedures

研究组 & 干预措施

childhood cancer survivors & and one parent/legal guardian

The study plans to recruit 30 childhood cancer survivors and a parent/legal guardian for each survivor. Participants will be provided with a Fitbit Inspire HR wearable device to record their step counts for two weeks pre-intervention, and over the six-month follow-up period (3-month intervention and 3month follow-up).

干预措施: Fitbit Inspire HR

childhood cancer survivors & and one parent/legal guardian

The study plans to recruit 30 childhood cancer survivors and a parent/legal guardian for each survivor. Participants will be provided with a Fitbit Inspire HR wearable device to record their step counts for two weeks pre-intervention, and over the six-month follow-up period (3-month intervention and 3month follow-up).

干预措施: Questionaires

结局指标

主要结局

Acceptability of the intervention

时间窗: 3 months

(i.e., all four responses on the AIM rates as either a 4 or 5 on a 5-point Likert scale of acceptability);

次要结局

  • hours of sleep per night(3 months)
  • step count(3 months)

研究点 (1)

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