Game-Based Physical Activity in Childhood Cancer Survivors

Not Applicable

Active, not recruiting

• Conditions: Survivors of Childhood Cancer
• Interventions: Other: Fitbit Inspire HR; Other: Questionaires

• Registration Number: NCT04266080
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-02-07
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
childhood cancer survivors & and one parent/legal guardian	Fitbit Inspire HR	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).
childhood cancer survivors & and one parent/legal guardian	Questionaires	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).

Primary Outcome Measures

Name	Time	Method
Acceptability of the intervention	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);

Secondary Outcome Measures

Name	Time	Method
hours of sleep per night	3 months	by FitBit-type devices
step count	3 months	step count by FitBit-type devices

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States