Trial Outcomes & Findings for Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors (NCT NCT02688192)
NCT ID: NCT02688192
Last Updated: 2021-04-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline
Results posted on
2021-04-09
Participant Flow
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).
Participant milestones
| Measure |
Arm I (Intervention)
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. Participate in a fitness program which includes:
* 8 group meetings over 90 minutes weekly
* Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
13
|
19
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
| Measure |
Arm I (Intervention)
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. Participate in a fitness program which includes:
* 8 group meetings over 90 minutes weekly
* Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm I (Intervention)
n=25 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. Participate in a fitness program which includes:
* 8 group meetings over 90 minutes weekly
* Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=24 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18.88 years
n=5 Participants
|
18.25 years
n=7 Participants
|
18.56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineFeasibility 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).
Outcome measures
| Measure |
Arm I (Intervention)
n=25 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=24 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Feasibility of the Technology-enhanced Fitness Program
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (3 months)Percentage of participants who compete the 3 month assessment
Outcome measures
| Measure |
Arm I (Intervention)
n=25 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=24 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Feasibility - Retention
|
15 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (3 months)Population: Only participants with complete data were included in this analysis.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=15 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=21 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Fatigue Sleep/Rest (post-intervention))
|
63.10 score on a scale
Standard Deviation 24.78
|
65.72 score on a scale
Standard Deviation 17.95
|
|
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Fatigue Cognitive (baseline)
|
57.74 score on a scale
Standard Deviation 24.78
|
70.08 score on a scale
Standard Deviation 22.59
|
|
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Fatigue Cognitive (post-intervention)
|
63.69 score on a scale
Standard Deviation 26.27
|
75.38 score on a scale
Standard Deviation 20.45
|
|
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Fatigue general (baseline)
|
60.12 score on a scale
Standard Deviation 25.72
|
71.02 score on a scale
Standard Deviation 12.76
|
|
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Fatigue general (post-intervention)
|
65.18 score on a scale
Standard Deviation 23.60
|
71.40 score on a scale
Standard Deviation 13.44
|
|
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Fatigue Sleep/Rest (baseline)
|
55.95 score on a scale
Standard Deviation 20.78
|
62.88 score on a scale
Standard Deviation 15.90
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (3 months)Population: Only participants with complete data were included in this analysis.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=15 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=21 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
HRQOL: Physical Summary (baseline)
|
72.10 score on a scale
Standard Deviation 21.10
|
79.75 score on a scale
Standard Deviation 8.32
|
|
Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
HRQOL: Physical Summary (post-intervention)
|
74.11 score on a scale
Standard Deviation 20.74
|
81.68 score on a scale
Standard Deviation 9.56
|
|
Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
HRQOL: Psycho social Summary (baseline)
|
72.64 score on a scale
Standard Deviation 12.28
|
77.92 score on a scale
Standard Deviation 12.14
|
|
Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
HRQOL: Psycho social Summary (post-intervention)
|
70.00 score on a scale
Standard Deviation 16.17
|
75.92 score on a scale
Standard Deviation 11.98
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (3 months)Population: Only participants with complete data were included in this analysis.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=15 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=21 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
estimated VO2 max (baseline)
|
36.67 ml/kg/min
Standard Deviation 7.03
|
40.61 ml/kg/min
Standard Deviation 9.60
|
|
Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
estimated VO2 max (post-intervention)
|
39.08 ml/kg/min
Standard Deviation 9.48
|
39.80 ml/kg/min
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (3 months)Population: Only participant with complete data were included.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=15 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
n=21 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Lower Body 1-RM (post-intervention)
|
247.23 kg
Standard Deviation 109.76
|
219.71 kg
Standard Deviation 89.85
|
|
Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Upper Body 1-RM (baseline)
|
35.78 kg
Standard Deviation 22.76
|
45.51 kg
Standard Deviation 25.83
|
|
Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Upper Body 1-RM (post-intervention)
|
40.50 kg
Standard Deviation 24.26
|
48.48 kg
Standard Deviation 25.40
|
|
Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Lower Body 1-RM (baseline)
|
191.93 kg
Standard Deviation 80.76
|
199.78 kg
Standard Deviation 84.56
|
SECONDARY outcome
Timeframe: Duration of the FitSurvivor intervention (12 weeks)Population: All participants from Arm I and Arm II who started the intervention were included. Those who dropped out prior to starting any sessions (n=7) were excluded from this analysis.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=42 Participants
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
4. 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
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Waitlist Control [WLC])
Assessment including
1. Wear an electronic accelerometer
2. Quality of life assessment
3. Physical fitness evaluation
After waiting 6 months they will begin the fitness program as described in Arm I
Exercise Intervention: Participate in fitness program
Internet-Based Intervention: Engage in private social support messaging and Use the mobile app
Monitoring Device: Wear an electronic accelerometer
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Feasibility - Engagement With the App
# of Likes/Comments posted
|
0.62 counts
Standard Deviation 1.51
|
—
|
|
Feasibility - Engagement With the App
# In-app workouts
|
6.50 counts
Standard Deviation 10.69
|
—
|
|
Feasibility - Engagement With the App
Total in-app points earned
|
165.48 counts
Standard Deviation 287.74
|
—
|
|
Feasibility - Engagement With the App
# Achievements unlocked
|
8.50 counts
Standard Deviation 4.63
|
—
|
Adverse Events
Arm I (FitSurvivor Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Waitlist Control [WLC])
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place