- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Taipei City
-
Taipei, Taipei City, Tchaj-wan
- Tri-Service General Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Jiný: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Preference for Aggressive Life-Sustaining Treatments
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Hsueh-Hsing Pan, PhD, National Defense Medical University
- Vrchní vyšetřovatel: Yu-Shiue Lin, National Defense Medical University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- TSGHIRB No. A202305148
- TSGH_E_113274 (Jiné číslo grantu/financování: Tri-Service General Hospital)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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