Game-Based Physical Activity in Childhood Cancer Survivors

Survivors of Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04266080
• Other study ID #: 20-040
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study will also look at whether the game-based exercise plan improves childhood cancer survivors' quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Survivors of Childhood Cancer

Intervention

Other:
• Fitbit Inspire HR
assessing step counts
• Questionaires
Patient-Reported Outcomes Measurement Information System (PROMIS)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Sohn Conference Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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);	3 months
Secondary	step count	step count by FitBit-type devices	3 months
Secondary	hours of sleep per night	by FitBit-type devices	3 months

External Links

•   Memorial Sloan Kettering Cancer Center