Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Teens Taking Charge: Managing Cancer Online

7 oktober 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

73

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster Children's Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Parents and adolescents will be eligible to participate if the adolescents are:

    1. between 12-18 years of age
    2. diagnosed with cancer (at least 3 months from diagnosis)
    3. on active treatment
    4. able to speak and read English and/or French at a Grade 6 level

Exclusion Criteria:

  • Adolescents will be excluded if they:

    1. have major cognitive impairments
    2. have reduced executive function that may impact their ability to understand and use the online program
    3. are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Controlegroep
Gedragsmatig: Standard Medical Care and Cancer Resource Center
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.
Experimenteel: Experimentele groep de leiding nemen
Gedragsmatig: Taking Charge: Managing Cancer Online
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Participant Accrual and Dropout Rates
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 12 weeks
Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents
12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Knowledge (Adolescent Cancer Knowledge Questionnaire)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Hospital for Sick Children

Medewerkers

McGill University
University of Alberta
McMaster University
Hamilton Health Sciences Corporation
Children's Hospital of Eastern Ontario
Institute for Clinical Evaluative Sciences
St. Justine's Hospital
Université de Montréal

Onderzoekers

  • Hoofdonderzoeker: Jennifer N Stinson, PhD, CPNP, The Hospital for Sick Children

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2016

Primaire voltooiing (Werkelijk)

1 april 2019

Studie voltooiing (Werkelijk)

1 april 2019

Studieregistratiedata

Eerst ingediend

17 november 2014

Eerst ingediend dat voldeed aan de QC-criteria

21 november 2014

Eerst geplaatst (Schatting)

24 november 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

7 oktober 2019

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 1000045896

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren