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Active, Not Recruiting

NCT Number: NCT04266080

Game-Based Physical Activity in Childhood Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit Inspire HR

Other

assessing step counts

Questionaires

Other

Patient-Reported Outcomes Measurement Information System (PROMIS)

Primary outcomes

  1. 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);

Secondary outcomes

  1. step count

    Time frame: 3 months

    step count by FitBit-type devices

  2. hours of sleep per night

    Time frame: 3 months

    by FitBit-type devices

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Sohn Conference Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2020
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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