Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors (TLCFIT)
7 de abril de 2021 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
13 años a 25 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Arm I (Intervention)
Assessment including
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Estudios complementarios
Otros nombres:
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Otros nombres:
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Comparador activo: Arm II (Waitlist Control [WLC])
Assessment including
After waiting 6 months they will begin the fitness program as described in Arm I |
Estudios complementarios
Otros nombres:
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of the Technology-enhanced Fitness Program
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility - Retention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Katie Devine, Rutgers Cancer Institute of New Jersey
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de enero de 2014
Finalización primaria (Actual)
22 de mayo de 2018
Finalización del estudio (Actual)
30 de julio de 2018
Fechas de registro del estudio
Enviado por primera vez
30 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
17 de febrero de 2016
Publicado por primera vez (Estimar)
23 de febrero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
7 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro2013003658
- P30CA072720 (Subvención/contrato del NIH de EE. UU.)
- NCI-2015-01841 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 131323 (Otro identificador: Rutgers Cancer Institute of New Jersey)
- K07CA174728 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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