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Game-Based Physical Activity in Childhood Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266080
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Sohn Conference Foundation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Survivors of Childhood Cancer Other: Fitbit Inspire HR Other: Questionaires Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single-arm pilot study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Other: Fitbit Inspire HR
assessing step counts

Other: Questionaires
Patient-Reported Outcomes Measurement Information System (PROMIS)




Primary Outcome Measures :
  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);



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 (7 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266080


Contacts
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Contact: Danielle Friedman, MD 212-639-7376 friedmad@mskcc.org
Contact: Stephen Sands, PsyD 646-888-0023

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Claire Friedman, MD    646-888-4247      
Contact: Stephen Sands, PsyD    646-888-0023      
Principal Investigator: Claire Friedman, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Sohn Conference Foundation
Investigators
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Principal Investigator: Danielle Friedman, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04266080    
Other Study ID Numbers: 20-040
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Game-Based
Physical Activity
20-040