Clinical trial · Interventional
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
NCT04266080CI-TRIAL-00104580active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Survivors of Childhood Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit Inspire HR | Other | — | UNRESOLVED |
| Questionaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- childhood cancer survivors & and one parent/legal guardian
- description
- 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).
- interventionNames
- Other: Fitbit Inspire HR
- Other: Questionaires
Primary outcomes (1)
- measure
- Acceptability of the intervention
- timeFrame
- 3 months
- description
- (i.e., all four responses on the AIM rates as either a 4 or 5 on a 5-point Likert scale of acceptability);
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.