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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
49
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Ancillary studies
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
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).
Time frame: Baseline
Feasibility - Retention
Percentage of participants who compete the 3 month assessment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of the FitSurvivor intervention (12 weeks)
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