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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2020
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 4, 2026
March 1, 2026
7 years
February 10, 2020
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (2)
step count
3 months
hours of sleep per night
3 months
Study Arms (1)
childhood cancer survivors & and one parent/legal guardian
EXPERIMENTALThe 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).
Interventions
assessing step counts
Patient-Reported Outcomes Measurement Information System (PROMIS)
Eligibility Criteria
You may qualify if:
- 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
- +8 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Sohn Conference Foundationcollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Friedman, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 12, 2020
Study Start
February 7, 2020
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.