Teens Taking Charge: Managing Cancer Online
7. října 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
73
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 4K1
- McMaster Children's Hospital
-
Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital Eastern Ontario
-
-
Quebec
-
Montreal, Quebec, Kanada, H3T 1C5
- CHU Sainte-Justine
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
12 let až 18 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Kontrolní skupina
|
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.
|
|
Experimentální: Vedení experimentální skupiny
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Participant Accrual and Dropout Rates
Časové okno: 12 weeks
|
These rates will be centrally tracked by the Clinical Research Project Coordinator
|
12 weeks
|
|
Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)
Časové okno: 12 weeks
|
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
|
12 weeks
|
|
Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)
Časové okno: 12 weeks
|
Post-treatment, adolescents with cancer and their parents in the intervention group will rate their acceptability of and satisfaction with the intervention
|
12 weeks
|
|
Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)
Časové okno: 12 weeks
|
Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents
|
12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Knowledge (Adolescent Cancer Knowledge Questionnaire)
Časové okno: 12 weeks
|
Measured using the Adolescent Cancer Knowledge Questionnaire, a 15-item tool that assesses cancer-specific knowledge.
|
12 weeks
|
|
Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)
Časové okno: 12 weeks
|
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.
|
12 weeks
|
|
Treatment adherence (Medication Adherence Scale)
Časové okno: 12 weeks
|
Measured with the Medication Adherence Scale, a 4-item scale for assessing self-reported adherence.
|
12 weeks
|
|
Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)
Časové okno: 12 weeks
|
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.
|
12 weeks
|
|
Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)
Časové okno: 12 weeks
|
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.
|
12 weeks
|
|
Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)
Časové okno: 12 weeks
|
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.
|
12 weeks
|
|
Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)
Časové okno: 12 weeks
|
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.
|
12 weeks
|
|
Transition readiness (Cancer Transition Scales)
Časové okno: 12 weeks
|
Measured with the Cancer Transition Scales, which include sub-scales for 'cancer worry' (6 items), 'self-management skills' (15 items), and 'expectations' (12 items).
|
12 weeks
|
|
Health Related Quality of Life (PedsQL Cancer Module)
Časové okno: 12 weeks
|
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].
|
12 weeks
|
|
Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)
Časové okno: 12 weeks
|
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
|
12 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jennifer N Stinson, PhD, CPNP, The Hospital for Sick Children
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2016
Primární dokončení (Aktuální)
1. dubna 2019
Dokončení studie (Aktuální)
1. dubna 2019
Termíny zápisu do studia
První předloženo
17. listopadu 2014
První předloženo, které splnilo kritéria kontroly kvality
21. listopadu 2014
První zveřejněno (Odhad)
24. listopadu 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. října 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. října 2019
Naposledy ověřeno
1. října 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 1000045896
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .