Game-Based Physical Activity in Childhood Cancer Survivors

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Survivors of Childhood Cancer
• Intervention / Treatment: Other: Fitbit Inspire HR; Other: Questionaires

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Fitbit Inspire HR; assessing step counts; Other: Questionaires; Patient-Reported Outcomes Measurement Information System (PROMIS)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Sohn Conference Foundation
• Investigators: Principal Investigator: Danielle Friedman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Game-Based; 20-040
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 20-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No