Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors (TLCFIT)
7 de abril de 2021 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
49
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Estados Unidos, 08903
- Rutgers Cancer Institute of New Jersey
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
13 anos a 25 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Arm I (Intervention)
Assessment including
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Estudos auxiliares
Outros nomes:
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Outros nomes:
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Comparador Ativo: Arm II (Waitlist Control [WLC])
Assessment including
After waiting 6 months they will begin the fitness program as described in Arm I |
Estudos auxiliares
Outros nomes:
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility of the Technology-enhanced Fitness Program
Prazo: Baseline
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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).
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Baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility - Retention
Prazo: Baseline to post-intervention (3 months)
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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
Prazo: 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
Prazo: Baseline to post-intervention (3 months)
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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
Prazo: Baseline to post-intervention (3 months)
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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)
Prazo: Baseline to post-intervention (3 months)
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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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Katie Devine, Rutgers Cancer Institute of New Jersey
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de janeiro de 2014
Conclusão Primária (Real)
22 de maio de 2018
Conclusão do estudo (Real)
30 de julho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
30 de novembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de fevereiro de 2016
Primeira postagem (Estimativa)
23 de fevereiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro2013003658
- P30CA072720 (Concessão/Contrato do NIH dos EUA)
- NCI-2015-01841 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 131323 (Outro identificador: Rutgers Cancer Institute of New Jersey)
- K07CA174728 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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