Clinical trial NCT02688192: Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors
Official title: Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Fatigue
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2016-02-23
Enrollment: 49
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies a mobile health fitness program for adolescent and young adult childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk to have negative late effects from treatment and to develop chronic health conditions. A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early mortality. Physical activity reduces the risk for cardiovascular disease and early mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and it is also positively associated with quality of life. Programs and technologies that promote physical activity are important because health behaviors adopted by adolescent and young adult childhood cancer survivors are likely to continue into adulthood. A mobile health fitness application may motivate adolescent and young adult childhood cancer survivors to engage and maintain physical activity.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.

SECONDARY OBJECTIVES:

I. Determine the effectiveness of the technology-enhanced fitness program on participants' cardiorespiratory fitness and muscular fitness.

II. Examine the effects of the program on secondary outcomes of health related quality of life (HRQOL) and fatigue.

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I (Intervention): Participants attend 8 group meetings weekly, wear an electronic accelerometer, engage in private social support messaging within the app and Facebook private groups, and then use the mobile app for 4 weeks without in-person groups.

ARM II (WAITLIST CONTROL \[WLC\]): After the 6 month assessment, participants receive the FitSurvivor intervention as in arm I.

Eligibility criteria: Inclusion Criteria:

* Any diagnosis of cancer prior to age 21
* Off treatment for at least 6 months
* For patients \< 18 years, parents must give informed consent and patient must give assent; patients \>= 18 must give informed consent

Exclusion Criteria:

* Any medical contraindication to exercise according to a physician or physician's designee
* Non-English speaking
* Current physical activity level exceeding Centers for Disease Control and Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for 5+ days/week (wk) including 3+ days of vigorous intensity activities and muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+ days/wk for children \< 18 and 150 min of moderate vigorous exercise or 75 min of vigorous exercise/wk and 2+ days of muscle strengthening activities for adults \>= 18); the CDC guidelines are used to determine exercise prescription in our intervention; individuals already exceeding the guidelines would be unlikely to benefit from participating
* Significant developmental delay per patient, parent, or physician report
* Pregnant (per patient report); if participant becomes pregnant during the course of the study, she will be removed from further participation

Primary outcomes:
measure: Feasibility of the Technology-enhanced Fitness Program
timeFrame: Baseline
Secondary outcomes:
measure: Feasibility - Retention
timeFrame: Baseline to post-intervention (3 months)
measure: Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
timeFrame: Baseline to post-intervention (3 months)
measure: Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
timeFrame: Baseline to post-intervention (3 months)
measure: Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
timeFrame: Baseline to post-intervention (3 months)
measure: Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
timeFrame: Baseline to post-intervention (3 months)
measure: Feasibility - Engagement With the App
timeFrame: Duration of the FitSurvivor intervention (12 weeks)
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Katie Devine
role: PRINCIPAL_INVESTIGATOR
References: