- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07712237
Web-Based Advance Care Planning for Patients With Advanced Cancer
A Web-Based Advance Care Planning Intervention to Reduce Preferences for Aggressive Life-Sustaining Treatments in Patients With Advanced Cancer: A Randomized Controlled Trial
The goal of this clinical trial is to determine whether a web-based advance care planning (ACP) intervention can reduce preferences for aggressive life-sustaining treatments among patients with advanced cancer.
The main questions it aims to answer are:
- Does a web-based ACP intervention reduce preferences for aggressive life-sustaining treatments among patients with advanced cancer?
- Does a web-based ACP intervention support informed medical decision-making regarding future care?
Researchers will compare a web-based ACP intervention plus a Patient Right to Autonomy Act leaflet with a Patient Right to Autonomy Act leaflet alone to determine whether the web-based ACP intervention is more effective in reducing preferences for aggressive life-sustaining treatments.
Participants will:
- Be randomly assigned to either an intervention group or a control group
- Receive either a web-based ACP educational program plus a Patient Right to Autonomy Act leaflet, or a Patient Right to Autonomy Act leaflet alone
- Complete questionnaires at baseline, immediately after the intervention, and one week after the intervention
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Advance care planning (ACP) is a process that enables individuals to understand and communicate their values, goals, and preferences regarding future medical care. ACP is particularly important for patients with advanced cancer, who may face complex decisions regarding life-sustaining treatments and end-of-life care. However, ACP participation remains limited, and innovative approaches are needed to improve patient engagement.
This study was designed to evaluate the effectiveness of a web-based ACP intervention in reducing preferences for aggressive life-sustaining treatments among patients with advanced cancer. The intervention was developed to provide accessible ACP education and information regarding the Patient Right to Autonomy Act in Taiwan.
A single-blind randomized controlled trial design was used. A total of 110 patients with stage III or IV cancer were recruited and randomly assigned to either an intervention group (n = 55) or a control group (n = 55). Participants in the intervention group received a web-based ACP educational program in addition to a Patient Right to Autonomy Act leaflet, whereas participants in the control group received the leaflet alone.
Outcome assessments were conducted at baseline (T1), immediately after the intervention (T2), and one week after the intervention (T3). The primary objective was to determine whether the web-based ACP intervention reduced preferences for aggressive life-sustaining treatments. The study also examined factors associated with treatment preferences and medical decision-making.
The findings of this study may contribute to the development of accessible ACP interventions and support informed decision-making among patients with advanced cancer.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Taipei City
-
Taipei, Taipei City, Taïwan
- Tri-Service General Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Diagnosed with advanced cancer (stage III or IV)
- Aged 18 years or older
- Able to communicate fluently in Mandarin Chinese or Taiwanese
- Able and willing to provide informed consent
- No cognitive impairment
- Have access to Internet-connected electronic devices at home
- Have not previously received advance care planning (ACP) consultation
- Have not completed an advance directive (AD)
Exclusion Criteria:
- No access to Internet-connected electronic devices at home
- Unable to operate Internet-based electronic devices
- Previous participation in ACP consultation or completion of an AD
- Cognitive impairment
- Severe physical or psychological symptoms that would interfere with participation in the study
- Concurrent participation in another intervention study
- Refusal to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Web-Based ACP Intervention Group
Participants received a web-based advance care planning (ACP) educational program in addition to a Patient Right to Autonomy Act leaflet.
|
A web-based educational program designed to improve advance care planning knowledge, promote informed decision-making, and facilitate discussions regarding future medical care among patients with advanced cancer.
An educational leaflet providing information about the Patient Right to Autonomy Act and advance care planning.
|
|
Autre: Control Group
Participants received a Patient Right to Autonomy Act leaflet only.
|
An educational leaflet providing information about the Patient Right to Autonomy Act and advance care planning.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Preference for Aggressive Life-Sustaining Treatments
Délai: Baseline and 1 Week After Intervention
|
Preferences for aggressive life-sustaining treatments were assessed using the Life-Sustaining Treatment Preference Questionnaire.
Higher scores indicate stronger preferences for aggressive life-sustaining treatments.
Changes from baseline were compared between the intervention and control groups.
|
Baseline and 1 Week After Intervention
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Hsueh-Hsing Pan, PhD, National Defense Medical University
- Chercheur principal: Yu-Shiue Lin, National Defense Medical University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- TSGHIRB No. A202305148
- TSGH_E_113274 (Autre subvention/numéro de financement: Tri-Service General Hospital)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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