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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04266080
Enrollment
48
Registered
2020-02-12
Start date
2020-02-07
Completion date
2027-02-01
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survivors of Childhood Cancer

Keywords

Game-Based, Physical Activity, 20-040

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.

Interventions

OTHERFitbit Inspire HR

assessing step counts

Patient-Reported Outcomes Measurement Information System (PROMIS)

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
Sohn Conference Foundation
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This is a single-arm pilot study.

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the intervention3 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

MeasureTime frameDescription
step count3 monthsstep count by FitBit-type devices
hours of sleep per night3 monthsby FitBit-type devices

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDanielle Friedman, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026