Survivors of Childhood CancerNCT04266080
Game-Based Physical Activity in Childhood Cancer Survivors
A study testing Fitbit Inspire HR and Questionaires in people with Survivors of Childhood Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Survivors of Childhood Cancer
- What is being tested?
- Fitbit Inspire HR and Questionaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Survivors of Childhood Cancer
- Being tested
- Fitbit Inspire HR, Questionaires
- Keywords
- Game-Based, Physical Activity, 20-040
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Inspire HROther
assessing step counts
QuestionairesOther
Patient-Reported Outcomes Measurement Information System (PROMIS)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Fitbit Inspire HR; Other: Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: 3 months
Secondary outcomes (2)
step count
step count by FitBit-type devices
Measured: 3 months
hours of sleep per night
by FitBit-type devices
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start7 Feb 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm pilot study.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sohn Conference Foundation
- Responsible party
- Sponsor
- Investigators
- Danielle Friedman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266080
- Sponsor's protocol ID
- 20-040
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study
- ClinicalTrials.gov ID
- NCT04266080
- Acronym / sponsor ID
- 20-040
- Conditions
- Survivors of Childhood Cancer
- Keywords
- Game-Based, Physical Activity, 20-040
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sohn Conference Foundation
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm pilot study.
| Arm | Type | Receives |
|---|---|---|
| childhood cancer survivors & and one parent/legal guardian | Experimental | Other: Fitbit Inspire HR, Other: QuestionairesThe 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). |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Inspire HRassessing step counts | Other | childhood cancer survivors & and one parent/legal guardian |
| QuestionairesPatient-Reported Outcomes Measurement Information System (PROMIS) | Other | childhood cancer survivors & and one parent/legal guardian |
Primary outcome
Acceptability of the intervention
Time frame: 3 months
(i.e., all four responses on the AIM rates as either a 4 or 5 on a 5-point Likert scale of acceptability);
2 secondary outcomes
step count
Time frame: 3 months
hours of sleep per night
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Friedman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Inspire HR and Questionaires in people with Survivors of Childhood Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.