Clinical trial NCT04266080: Game-Based Physical Activity in Childhood Cancer Survivors
Official title: Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Survivors of Childhood Cancer
Keywords: Game-Based
Physical Activity
20-040
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Sohn Conference Foundation
First posted: 2020-02-12
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm pilot study.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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 (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

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: 3 months
Secondary outcomes:
measure: step count
timeFrame: 3 months
measure: hours of sleep per night
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: