Game-Based Physical Activity in Childhood Cancer Survivors

Study Overview
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Brief Summary
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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.

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

Conditions
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Survivors of Childhood Cancer

Intervention / Treatment
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* Other: Fitbit Inspire HR
* Other: Questionaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: childhood cancer survivors & and one parent/legal guardian<br>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). | Other: Fitbit Inspire HR<br>* assessing step counts<br>Other: Questionaires<br>* Patient-Reported Outcomes Measurement Information System (PROMIS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the intervention | (i.e., all four responses on the AIM rates as either a 4 or 5 on a 5-point Likert scale of acceptability); | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| step count | step count by FitBit-type devices | 3 months | 
| hours of sleep per night | by FitBit-type devices | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Game-Based, Physical Activity, 20-040