Game-Based Physical Activity in Childhood Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Survivors of Childhood Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-arm pilot study.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Fitbit Inspire HR

Intervention Type OTHER

assessing step counts

Questionaires

Intervention Type OTHER

Patient-Reported Outcomes Measurement Information System (PROMIS)

Interventions

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Fitbit Inspire HR

assessing step counts

Intervention Type OTHER

Questionaires

Patient-Reported Outcomes Measurement Information System (PROMIS)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes