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

7. april 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, Forente stater, 08903
        • Rutgers Cancer Institute of New Jersey

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 25 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Atferdsmessig: Exercise Intervention
Participate in fitness program
Atferdsmessig: Internet-Based Intervention
Engage in private social support messaging and Use the mobile app
Enhet: Monitoring Device
Wear an electronic accelerometer
Andre navn:
  • Observere
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
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Atferdsmessig: Exercise Intervention
Participate in fitness program
Atferdsmessig: Internet-Based Intervention
Engage in private social support messaging and Use the mobile app
Enhet: Monitoring Device
Wear an electronic accelerometer
Andre navn:
  • Observere

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of the Technology-enhanced Fitness Program
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility - Retention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

Rutgers, The State University of New Jersey

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. januar 2014

Primær fullføring (Faktiske)

22. mai 2018

Studiet fullført (Faktiske)

30. juli 2018

Datoer for studieregistrering

Først innsendt

30. november 2015

Først innsendt som oppfylte QC-kriteriene

17. februar 2016

Først lagt ut (Anslag)

23. februar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro2013003658
  • P30CA072720 (U.S. NIH-stipend/kontrakt)
  • NCI-2015-01841 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • 131323 (Annen identifikator: Rutgers Cancer Institute of New Jersey)
  • K07CA174728 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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