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

7 april 2021 uppdaterad av: Katie Devine, PhD, MPH, Rutgers, The State University of New Jersey

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

49

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, Förenta staterna, 08903
        • Rutgers Cancer Institute of New Jersey

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 25 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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 of 90 minutes weekly
    • Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app
Övrig: Livskvalitetsbedömning
Sidostudier
Andra namn:
  • Livskvalitetsbedömning
Beteende: Exercise Intervention
Participate in fitness program
Beteende: Internet-Based Intervention
Engage in private social support messaging and Use the mobile app
Enhet: Monitoring Device
Wear an electronic accelerometer
Andra namn:
  • Övervaka
Aktiv komparator: 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
Övrig: Livskvalitetsbedömning
Sidostudier
Andra namn:
  • Livskvalitetsbedömning
Beteende: Exercise Intervention
Participate in fitness program
Beteende: Internet-Based Intervention
Engage in private social support messaging and Use the mobile app
Enhet: Monitoring Device
Wear an electronic accelerometer
Andra namn:
  • Övervaka

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of the Technology-enhanced Fitness Program
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility - Retention
Tidsram: Baseline to post-intervention (3 months)
Percentage of participants who compete the 3 month assessment
Baseline to post-intervention (3 months)
Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
Tidsram: 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.
Baseline to post-intervention (3 months)
Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Tidsram: 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.
Baseline to post-intervention (3 months)
Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
Tidsram: 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.
Baseline to post-intervention (3 months)
Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
Tidsram: 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.
Baseline to post-intervention (3 months)
Feasibility - Engagement With the App
Tidsram: 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.
Duration of the FitSurvivor intervention (12 weeks)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Rutgers, The State University of New Jersey

Samarbetspartners

National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Utredare

  • Huvudutredare: Katie Devine, Rutgers Cancer Institute of New Jersey

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 januari 2014

Primärt slutförande (Faktisk)

22 maj 2018

Avslutad studie (Faktisk)

30 juli 2018

Studieregistreringsdatum

Först inskickad

30 november 2015

Först inskickad som uppfyllde QC-kriterierna

17 februari 2016

Första postat (Uppskatta)

23 februari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 april 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 april 2021

Senast verifierad

1 april 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro2013003658
  • P30CA072720 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2015-01841 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • 131323 (Annan identifierare: Rutgers Cancer Institute of New Jersey)
  • K07CA174728 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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