Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Acceptability of the intervention
研究概览
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.
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Not currently exercising at least 30 minutes per day (5 days/week)
- •ECOG Performance Status of 0-1
- •Parent/legal guardian:
- •Parent or legal guardian of a childhood cancer survivor treated with cardiotoxic therapy (anthracyclines, chest radiation, total body irradiation)
- •Parent or legal guardian of a child age 10-16 years who is at least 2 years from completion of systemic cancer therapy
- •Ability to speak and understand English
- •Ability to complete all protocol assessments
- •Ability to provide informed consent
- •Ambulatory and able to perform all study requirements
- •Access to a mobile device with SMS text messaging capability
- •Is the parent or legal guardian of a childhood cancer survivor who is willing to participate in this study as a dyad
- •Willing to receive daily SMS text message alerts
- •ECOG Performance Status of 0-1
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 (Other)
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 (Other)
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)