Game-Based Physical Activity in Childhood Cancer Survivors | NCT04266080

Studies
Game-Based Physical Activity in Childhood Cancer Survivors

NCT04266080

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Active, not recruiting

Last Update Posted

Mar 4, 2026Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Survivors of Childhood Cancer

Interventions

Fitbit Inspire HR
Questionaires

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2020Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 4, 2026Actual

Name	Class
Sohn Conference Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
childhood cancer survivors & and one parent/legal guardian	Experimental	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 Other: Questionaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fitbit Inspire HR	Other	assessing step counts	childhood cancer survivors & and one parent/legal guardian

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Danielle Friedman, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

Label	URL
Memorial Sloan Kettering Cancer Center	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided