- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688192
Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors (TLCFIT)
Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm I (Intervention)
Assessment including
|
Ancillary studies
Other Names:
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Other Names:
|
Active Comparator: Arm II (Waitlist Control [WLC])
Assessment including
After waiting 6 months they will begin the fitness program as described in Arm I |
Ancillary studies
Other Names:
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the Technology-enhanced Fitness Program
Time Frame: 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).
|
Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - Retention
Time Frame: Baseline to post-intervention (3 months)
|
Percentage of participants who compete the 3 month assessment
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Baseline to post-intervention (3 months)
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Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Time Frame: Baseline to post-intervention (3 months)
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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.
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Baseline to post-intervention (3 months)
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Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Time Frame: 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.
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Baseline to post-intervention (3 months)
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Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
Time Frame: 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.
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Baseline to post-intervention (3 months)
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Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Time Frame: 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.
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Baseline to post-intervention (3 months)
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Feasibility - Engagement With the App
Time Frame: Duration of the FitSurvivor intervention (12 weeks)
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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.
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Duration of the FitSurvivor intervention (12 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Katie Devine, Rutgers Cancer Institute of New Jersey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2013003658
- P30CA072720 (U.S. NIH Grant/Contract)
- NCI-2015-01841 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 131323 (Other Identifier: Rutgers Cancer Institute of New Jersey)
- K07CA174728 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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