Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors

Study Overview
=================
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.

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

Conditions
-----------------
Survivorship, Fatigue

Intervention / Treatment
-----------------
* Behavioral: Exercise Intervention
* Behavioral: Internet-Based Intervention
* Device: Monitoring Device
* Other: Quality-of-Life Assessment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (Intervention)<br>Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app | Behavioral: Exercise Intervention<br>* Participate in fitness program<br>Behavioral: Internet-Based Intervention<br>* Engage in private social support messaging and Use the mobile app<br>Device: Monitoring Device<br>* Wear an electronic accelerometer<br>* Other names: Monitor;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Active Comparator: Arm II (Waitlist Control [WLC])<br>Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I | Behavioral: Exercise Intervention<br>* Participate in fitness program<br>Behavioral: Internet-Based Intervention<br>* Engage in private social support messaging and Use the mobile app<br>Device: Monitoring Device<br>* Wear an electronic accelerometer<br>* Other names: Monitor;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the Technology-enhanced Fitness Program | Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Retention | Percentage of participants who compete the 3 month assessment | Baseline to post-intervention (3 months) | 
| Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. | Baseline to post-intervention (3 months) | 
| Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. | Baseline to post-intervention (3 months) | 
| Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations. | Baseline to post-intervention (3 months) | 
| Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance. | Baseline to post-intervention (3 months) | 
| Feasibility - Engagement With the App | Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8. | Duration of the FitSurvivor intervention (12 weeks) |