Teens Taking Charge: Managing Cancer Online
7 octobre 2019 mis à jour par: Jennifer Stinson, The Hospital for Sick Children
Teens Taking Charge: A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer
Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education, self-monitoring capabilities, and social support to enhance disease self-management by adolescents with cancer.
While two interactive coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not focus on helping youth gain skills for transition and independence, and (3) do not provide opportunities for meaningful social support.
In summary, there is a crucial need to develop a comprehensive interactive Internet-based self-management program targeting AWC that is comprised of cancer education, self-management skills, and opportunities for social support, and that is cost-effective.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Cancer Online" Internet intervention that will help AWC to better cope with their disease, improve their HRQL, and enhance readiness to transition to adult health care using a sequential phased approach.
The first phase of this project has determined the self-management and transitional care needs of adolescents with cancer.
The second phase consisted of website development and usability testing to ensure the website is easy to use and understand, and is efficient and satisfying to complete.
Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3).
This will inform the design and methods of the main trial, and will permit us to obtain estimates of treatment effects on AWC health outcomes to inform the calculation of an appropriate sample size for the future definitive RCT (Phase 4).
The focus of this study is Phase 3. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group.
Type d'étude
Interventionnel
Inscription (Réel)
73
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
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- McMaster Children's Hospital
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital Eastern Ontario
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- CHU Sainte-Justine
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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
12 ans à 18 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Parents and adolescents will be eligible to participate if the adolescents are:
- between 12-18 years of age
- diagnosed with cancer (at least 3 months from diagnosis)
- on active treatment
- able to speak and read English and/or French at a Grade 6 level
Exclusion Criteria:
Adolescents will be excluded if they:
- have major cognitive impairments
- have reduced executive function that may impact their ability to understand and use the online program
- are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)
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: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Groupe de contrôle
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The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention.
In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about Cancer ("Cancer Resource Centre") and online assessments.
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Expérimental: Groupe expérimental de prise en charge
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n addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing Cancer Online" Internet self-management program.
The intervention is a 12-module interactive multi-component treatment protocol that consists of Cancer-specific education, self-management strategies, and social support that is available in English and French.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Participant Accrual and Dropout Rates
Délai: 12 weeks
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These rates will be centrally tracked by the Clinical Research Project Coordinator
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12 weeks
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Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)
Délai: 12 weeks
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Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the Clinical Research Project Coordinator
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12 weeks
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Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)
Délai: 12 weeks
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Post-treatment, adolescents with cancer and their parents in the intervention group will rate their acceptability of and satisfaction with the intervention
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12 weeks
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Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)
Délai: 12 weeks
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Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents
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12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge (Adolescent Cancer Knowledge Questionnaire)
Délai: 12 weeks
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Measured using the Adolescent Cancer Knowledge Questionnaire, a 15-item tool that assesses cancer-specific knowledge.
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12 weeks
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Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)
Délai: 12 weeks
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Measured by the Generalized Self-Efficacy-Sherer Scale, a 12-item scale that requires adolescents to indicate their level of agreement with a series of statements about self-efficacy.
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12 weeks
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Treatment adherence (Medication Adherence Scale)
Délai: 12 weeks
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Measured with the Medication Adherence Scale, a 4-item scale for assessing self-reported adherence.
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12 weeks
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Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)
Délai: 12 weeks
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Measured using the short form Brief Pain Inventory (BPI), a 15-item measure that includes scales for measuring pain intensity, impact of pain on functioning and well being, and pain interference.
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12 weeks
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Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)
Délai: 12 weeks
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Measured using the PedsQL Multidimensional Fatigue Module, an 18-item scale with validated versions for child report (ages 8-12 years), teen report (ages 13-18 years), and parental report for children and teens.
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12 weeks
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Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)
Délai: 12 weeks
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Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for individuals aged >12 years, which can be completed within 2-5 minutes.
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12 weeks
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Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)
Délai: 12 weeks
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Measured with the Perceived Social Support from Friends (PSS-Fr) Scale, a 20-item scale that assesses the extent to which an individual perceives that their friends fulfill their needs for support.
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12 weeks
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Transition readiness (Cancer Transition Scales)
Délai: 12 weeks
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Measured with the Cancer Transition Scales, which include sub-scales for 'cancer worry' (6 items), 'self-management skills' (15 items), and 'expectations' (12 items).
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12 weeks
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Health Related Quality of Life (PedsQL Cancer Module)
Délai: 12 weeks
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measured with the PedsQL Cancer Module, a 27-item scale, which has validated versions for child, teen, and parental report, and the Health Utility Index [HUI].
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12 weeks
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Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)
Délai: 12 weeks
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Measured by ascertaining direct health care costs and family out of pocket costs related to cancer care incurred over the 12-week study period using the Health Care Utilization form modified from the Ambulatory and Home Care Record84-90 as well as direct costs related to the online intervention technology, intervention training and personnel.
Quality adjusted life years will be calculated using the HUI to determine the incremental cost-effectiveness
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12 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jennifer N Stinson, PhD, CPNP, The Hospital for Sick Children
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 (Réel)
1 janvier 2016
Achèvement primaire (Réel)
1 avril 2019
Achèvement de l'étude (Réel)
1 avril 2019
Dates d'inscription aux études
Première soumission
17 novembre 2014
Première soumission répondant aux critères de contrôle qualité
21 novembre 2014
Première publication (Estimation)
24 novembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 octobre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 octobre 2019
Dernière vérification
1 octobre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 1000045896
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 .