SurvivorshipTLCFITNCT02688192
Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors
A study testing Exercise Intervention, Internet-Based Intervention and Monitoring Device in people with Survivorship and Fatigue, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Survivorship, Fatigue
- What is being tested?
- Exercise Intervention, Internet-Based Intervention and Monitoring Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2014to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Survivorship, Fatigue
- Being tested
- Exercise Intervention, Internet-Based Intervention, Monitoring Device, Quality-of-Life Assessment
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Participate in fitness program
Internet-Based InterventionBehavioural
Engage in private social support messaging and Use the mobile app
Monitoring DeviceDevice
Also called Monitor
Wear an electronic accelerometer
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Intervention) | Active comparator | 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 Receives: Behavioral: Exercise Intervention; Behavioral: Internet-Based Intervention; Device: Monitoring Device; Other: Quality-of-Life Assessment |
| Arm II (Waitlist Control [WLC]) | Active comparator | 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 Receives: Behavioral: Exercise Intervention; Behavioral: Internet-Based Intervention; Device: Monitoring Device; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (6)
Feasibility - Retention
Percentage of participants who compete the 3 month assessment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of the FitSurvivor intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start2 Jan 2014
- Primary completion22 May 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Katie Devine, PhD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Katie Devine, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688192
- Sponsor's protocol ID
- Pro2013003658
- Other IDs
- NCI-2015-01841, 131323, K07CA174728, P30CA072720
- Acronym
- TLCFIT
- Status last verified
- Apr 2021
- First submitted
- 30 Nov 2015
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT02688192
- Acronym / sponsor ID
- TLCFIT / Pro2013003658
- Conditions
- Survivorship, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- 2 Jan 2014 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Intervention) | Active comparator | Behavioral: Exercise Intervention, Behavioral: Internet-Based Intervention, Device: Monitoring Device, Other: Quality-of-Life AssessmentAssessment 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 |
| Arm II (Waitlist Control [WLC]) | Active comparator | Behavioral: Exercise Intervention, Behavioral: Internet-Based Intervention, Device: Monitoring Device, Other: Quality-of-Life AssessmentAssessment 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 |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionParticipate in fitness program | Behavioural | Arm I (Intervention), Arm II (Waitlist Control [WLC]) |
| Internet-Based InterventionEngage in private social support messaging and Use the mobile app | Behavioural | Arm I (Intervention), Arm II (Waitlist Control [WLC]) |
| Monitoring DeviceAlso: MonitorWear an electronic accelerometer | Device | Arm I (Intervention), Arm II (Waitlist Control [WLC]) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (Intervention), Arm II (Waitlist Control [WLC]) |
Primary outcome
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).
6 secondary outcomes
Feasibility - Retention
Time frame: Baseline to post-intervention (3 months)
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
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
Time frame: Baseline to post-intervention (3 months)
Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
Time frame: Baseline to post-intervention (3 months)
Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Time frame: Baseline to post-intervention (3 months)
Feasibility - Engagement With the App
Time frame: Duration of the FitSurvivor intervention (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Devine principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Internet-Based Intervention and Monitoring Device in people with Survivorship and Fatigue, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Technology-enhanced Fitness Program (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.