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Game-Based Physical Activity in Childhood Cancer Survivors

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ClinicalTrials.gov Identifier: NCT04266080
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : July 15, 2021
Sponsor:
Collaborator:
Sohn Conference Foundation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE February 10, 2020
First Posted Date  ICMJE February 12, 2020
Last Update Posted Date July 15, 2021
Actual Study Start Date  ICMJE February 7, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
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);
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • step count [ Time Frame: 3 months ]
    step count by FitBit-type devices
  • hours of sleep per night [ Time Frame: 3 months ]
    by FitBit-type devices
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Game-Based Physical Activity in Childhood Cancer Survivors
Official Title  ICMJE Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a single-arm pilot study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Survivors of Childhood Cancer
Intervention  ICMJE
  • Other: Fitbit Inspire HR
    assessing step counts
  • Other: Questionaires
    Patient-Reported Outcomes Measurement Information System (PROMIS)
Study Arms  ICMJE Experimental: childhood cancer survivors & and one parent/legal guardian
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).
Interventions:
  • Other: Fitbit Inspire HR
  • Other: Questionaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Danielle Friedman, MD 212-639-7376 friedmad@mskcc.org
Contact: Stephen Sands, PsyD 646-888-0023
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04266080
Other Study ID Numbers  ICMJE 20-040
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Sohn Conference Foundation
Investigators  ICMJE
Principal Investigator: Danielle Friedman, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP