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A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

5 mai 2015 mis à jour par: St. Jude Children's Research Hospital

A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity.

Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

  • To compare changes in levels of moderate and vigorous physical activity over 24 weeks.

SECONDARY OBJECTIVE:

  • To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks.

Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website.

After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.

Type d'étude

Interventionnel

Inscription (Réel)

105

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Tennessee
      • Memphis, Tennessee, États-Unis, 38105
        • St. Jude Children's Research Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

11 ans à 14 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)
  • 11 through 14 years of age
  • Not undergoing active treatment for cancer
  • Medical clearance from participant's attending physician via email
  • Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week
  • Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)

Exclusion Criteria:

  • Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website
  • Pregnant female
  • Inability to read and write English

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Comportemental: Activity Monitor
Measurement of physical activity.
Autres noms:
  • Tri-Axial Accelerometer
  • Zamzee
Comportemental: Interactive Website
Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Autres noms:
  • Zamzee Website
Comportemental: Educational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Autres noms:
  • Educational Brochure
Expérimental: Group B: Immediate Incentives

Participants use an activity monitor and the interactive website.

In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Comportemental: Activity Monitor
Measurement of physical activity.
Autres noms:
  • Tri-Axial Accelerometer
  • Zamzee
Comportemental: Interactive Website
Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Autres noms:
  • Zamzee Website
Comportemental: Educational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Autres noms:
  • Educational Brochure
Expérimental: Group C: Control
Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Comportemental: Activity Monitor
Measurement of physical activity.
Autres noms:
  • Tri-Axial Accelerometer
  • Zamzee
Comportemental: Educational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Autres noms:
  • Educational Brochure

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
Délai: Baseline, Week 24
The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.
Baseline, Week 24

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
Délai: Baseline and 24 weeks
The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.
Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
Délai: Baseline and 24 weeks
The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups
Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
Délai: Baseline and 24 weeks
The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
Délai: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
Délai: Baseline and 24 weeks
The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup
Délai: Baseline and 24 weeks
The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second
Délai: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second
Délai: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second
Délai: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second
Délai: Baseline and 24 weeks
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second
Délai: Baseline and 24 weeks
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

St. Jude Children's Research Hospital

Les enquêteurs

  • Chercheur principal: Kirsten K. Ness, PT, PhD, St. Jude Children's Research Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2013

Achèvement primaire (Réel)

1 avril 2014

Achèvement de l'étude (Réel)

1 avril 2014

Dates d'inscription aux études

Première soumission

18 janvier 2013

Première soumission répondant aux critères de contrôle qualité

24 janvier 2013

Première publication (Estimation)

29 janvier 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

21 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2015

Dernière vérification

1 avril 2015

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • ZAMZEE
  • NCI-2013-00384 (Identificateur de registre: NCI Clinical Trial Registration Program)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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