NCT02688192: TLCFIT

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

Completed NA Results posted Last updated 9 April 2021

What this trial tests

NA trial testing Exercise Intervention in Survivorship in 49 participants. Completed in 30 July 2018.

Timeline

2 January 2014

Primary endpoint
22 May 2018

30 July 2018

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	49
Start date	2 January 2014
Primary completion	22 May 2018
Estimated completion	30 July 2018
Sites	2 locations across United States

Drugs / interventions tested

• Exercise Intervention
• Internet-Based Intervention
• Monitoring Device
• Quality-of-Life Assessment

Conditions studied

• Survivorship — all drugs for Survivorship →
• Fatigue — all drugs for Fatigue →

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 13 to 25, any sex, with Survivorship or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of the Technology-enhanced Fitness Program Primary · Baseline

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).

Group	Value	95% CI
Arm I (Intervention)	25
Arm II (Waitlist Control [WLC])	24

Feasibility - Retention Secondary · Baseline to post-intervention (3 months)

Percentage of participants who compete the 3 month assessment

Group	Value	95% CI
Arm I (Intervention)	15
Arm II (Waitlist Control [WLC])	22

Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale Secondary · Baseline to post-intervention (3 months)

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.

Fatigue general (baseline)

Group	Value	95% CI
Arm I (Intervention)	60.12	± 25.72
Arm II (Waitlist Control [WLC])	71.02	± 12.76

Fatigue general (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	65.18	± 23.60
Arm II (Waitlist Control [WLC])	71.40	± 13.44

Fatigue Sleep/Rest (baseline)

Group	Value	95% CI
Arm I (Intervention)	55.95	± 20.78
Arm II (Waitlist Control [WLC])	62.88	± 15.90

Fatigue Sleep/Rest (post-intervention))

Group	Value	95% CI
Arm I (Intervention)	63.10	± 24.78
Arm II (Waitlist Control [WLC])	65.72	± 17.95

Fatigue Cognitive (baseline)

Group	Value	95% CI
Arm I (Intervention)	57.74	± 24.78
Arm II (Waitlist Control [WLC])	70.08	± 22.59

Fatigue Cognitive (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	63.69	± 26.27
Arm II (Waitlist Control [WLC])	75.38	± 20.45

Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale Secondary · Baseline to post-intervention (3 months)

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.

HRQOL: Physical Summary (baseline)

Group	Value	95% CI
Arm I (Intervention)	72.10	± 21.10
Arm II (Waitlist Control [WLC])	79.75	± 8.32

HRQOL: Physical Summary (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	74.11	± 20.74
Arm II (Waitlist Control [WLC])	81.68	± 9.56

HRQOL: Psycho social Summary (baseline)

Group	Value	95% CI
Arm I (Intervention)	72.64	± 12.28
Arm II (Waitlist Control [WLC])	77.92	± 12.14

HRQOL: Psycho social Summary (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	70.00	± 16.17
Arm II (Waitlist Control [WLC])	75.92	± 11.98

Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test Secondary · Baseline to post-intervention (3 months)

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.

estimated VO2 max (baseline)

Group	Value	95% CI
Arm I (Intervention)	36.67	± 7.03
Arm II (Waitlist Control [WLC])	40.61	± 9.60

estimated VO2 max (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	39.08	± 9.48
Arm II (Waitlist Control [WLC])	39.80	± 9.27

Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) Secondary · Baseline to post-intervention (3 months)

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.

Lower Body 1-RM (baseline)

Group	Value	95% CI
Arm I (Intervention)	191.93	± 80.76
Arm II (Waitlist Control [WLC])	199.78	± 84.56

Lower Body 1-RM (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	247.23	± 109.76
Arm II (Waitlist Control [WLC])	219.71	± 89.85

Upper Body 1-RM (baseline)

Group	Value	95% CI
Arm I (Intervention)	35.78	± 22.76
Arm II (Waitlist Control [WLC])	45.51	± 25.83

Upper Body 1-RM (post-intervention)

Group	Value	95% CI
Arm I (Intervention)	40.50	± 24.26
Arm II (Waitlist Control [WLC])	48.48	± 25.40

Feasibility - Engagement With the App Secondary · Duration of the FitSurvivor intervention (12 weeks)

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; poi

# In-app workouts

Group	Value	95% CI
ALL: Arm I (Intervention) and Arm II (WLC)	6.50	± 10.69

Total in-app points earned

Group	Value	95% CI
ALL: Arm I (Intervention) and Arm II (WLC)	165.48	± 287.74

# Achievements unlocked

Group	Value	95% CI
ALL: Arm I (Intervention) and Arm II (WLC)	8.50	± 4.63

# of Likes/Comments posted

Group	Value	95% CI
ALL: Arm I (Intervention) and Arm II (WLC)	0.62	± 1.51

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of FitSurvivor: A technology-enhanced group-based fitness intervention for adolescent and young adult survivors of childhood cancer.
   Devine KA, Viola A, Levonyan-Radloff K, Mackowski N, et al · · 2020 · cited 33× · PMID 32589339 · DOI 10.1002/pbc.28530