Survivorship, Fatigue
Conditions
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.
Interventions
BEHAVIORALExercise Intervention
Participate in fitness program
BEHAVIORALInternet-Based Intervention
Engage in private social support messaging and Use the mobile app
DEVICEMonitoring Device
Wear an electronic accelerometer
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Technology-enhanced Fitness Program | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | 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. |
| Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | 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. |
| Feasibility - Retention | Baseline to post-intervention (3 months) | Percentage of participants who compete the 3 month assessment |
| Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | 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. |
| Feasibility - Engagement With the App | 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; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8. |
| Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Arm I (Intervention) | Arm II (Waitlist Control [WLC]) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 18.88 years | 18.25 years | 18.56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Intervention) | Feasibility of the Technology-enhanced Fitness Program | 25 Participants |
| Arm II (Waitlist Control [WLC]) | Feasibility of the Technology-enhanced Fitness Program | 24 Participants |
Secondary
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)
Population: Only participants with complete data were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Intervention) | Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | estimated VO2 max (post-intervention) | 39.08 ml/kg/min | Standard Deviation 9.48 |
| Arm I (Intervention) | Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | estimated VO2 max (baseline) | 36.67 ml/kg/min | Standard Deviation 7.03 |
| Arm II (Waitlist Control [WLC]) | Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | estimated VO2 max (post-intervention) | 39.80 ml/kg/min | Standard Deviation 9.27 |
| Arm II (Waitlist Control [WLC]) | Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | estimated VO2 max (baseline) | 40.61 ml/kg/min | Standard Deviation 9.6 |
p-value: 0.29ANOVA
Secondary
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)
Population: Only participant with complete data were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Intervention) | 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 |
| Arm I (Intervention) | 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 |
| Arm I (Intervention) | 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 |
| Arm I (Intervention) | 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 |
| Arm II (Waitlist Control [WLC]) | Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | Upper Body 1-RM (post-intervention) | 48.48 kg | Standard Deviation 25.4 |
| Arm II (Waitlist Control [WLC]) | Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | Upper Body 1-RM (baseline) | 45.51 kg | Standard Deviation 25.83 |
| Arm II (Waitlist Control [WLC]) | Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | Lower Body 1-RM (post-intervention) | 219.71 kg | Standard Deviation 89.85 |
| Arm II (Waitlist Control [WLC]) | Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | Lower Body 1-RM (baseline) | 199.78 kg | Standard Deviation 84.56 |
Comparison: Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete datap-value: 0.019ANOVA
Comparison: Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.p-value: 0.34ANOVA
Secondary
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)
Population: Only participants with complete data were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Intervention) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Cognitive (baseline) | 57.74 score on a scale | Standard Deviation 24.78 |
| Arm I (Intervention) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue general (post-intervention) | 65.18 score on a scale | Standard Deviation 23.6 |
| Arm I (Intervention) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Sleep/Rest (post-intervention)) | 63.10 score on a scale | Standard Deviation 24.78 |
| Arm I (Intervention) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Sleep/Rest (baseline) | 55.95 score on a scale | Standard Deviation 20.78 |
| Arm I (Intervention) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Cognitive (post-intervention) | 63.69 score on a scale | Standard Deviation 26.27 |
| Arm I (Intervention) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue general (baseline) | 60.12 score on a scale | Standard Deviation 25.72 |
| Arm II (Waitlist Control [WLC]) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Cognitive (post-intervention) | 75.38 score on a scale | Standard Deviation 20.45 |
| Arm II (Waitlist Control [WLC]) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Sleep/Rest (post-intervention)) | 65.72 score on a scale | Standard Deviation 17.95 |
| Arm II (Waitlist Control [WLC]) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Cognitive (baseline) | 70.08 score on a scale | Standard Deviation 22.59 |
| Arm II (Waitlist Control [WLC]) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue general (baseline) | 71.02 score on a scale | Standard Deviation 12.76 |
| Arm II (Waitlist Control [WLC]) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue general (post-intervention) | 71.40 score on a scale | Standard Deviation 13.44 |
| Arm II (Waitlist Control [WLC]) | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | Fatigue Sleep/Rest (baseline) | 62.88 score on a scale | Standard Deviation 15.9 |
Comparison: Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.p-value: 0.39ANOVA
Comparison: Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.p-value: 0.49ANOVA
Comparison: Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.p-value: 0.83ANOVA
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Intervention) | Feasibility - Engagement With the App | # In-app workouts | 6.50 counts | Standard Deviation 10.69 |
| Arm I (Intervention) | Feasibility - Engagement With the App | Total in-app points earned | 165.48 counts | Standard Deviation 287.74 |
| Arm I (Intervention) | Feasibility - Engagement With the App | # Achievements unlocked | 8.50 counts | Standard Deviation 4.63 |
| Arm I (Intervention) | Feasibility - Engagement With the App | # of Likes/Comments posted | 0.62 counts | Standard Deviation 1.51 |
Secondary
Feasibility - Retention
Percentage of participants who compete the 3 month assessment
Time frame: Baseline to post-intervention (3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Intervention) | Feasibility - Retention | 15 Participants |
| Arm II (Waitlist Control [WLC]) | Feasibility - Retention | 22 Participants |
Secondary
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)
Population: Only participants with complete data were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Intervention) | 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 |
| Arm I (Intervention) | 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 21.1 |
| Arm I (Intervention) | 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 |
| Arm I (Intervention) | 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 |
| Arm II (Waitlist Control [WLC]) | Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | HRQOL: Psycho social Summary (post-intervention) | 75.92 score on a scale | Standard Deviation 11.98 |
| Arm II (Waitlist Control [WLC]) | Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | HRQOL: Physical Summary (post-intervention) | 81.68 score on a scale | Standard Deviation 9.56 |
| Arm II (Waitlist Control [WLC]) | Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | HRQOL: Psycho social Summary (baseline) | 77.92 score on a scale | Standard Deviation 12.14 |
| Arm II (Waitlist Control [WLC]) | Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | HRQOL: Physical Summary (baseline) | 79.75 score on a scale | Standard Deviation 8.32 |
Comparison: Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.p-value: 0.98ANOVA
Comparison: Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.p-value: 0.85ANOVA