- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Taipei City
-
Taipei, Taipei City, Taiwan
- Tri-Service General Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Muut: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Preference for Aggressive Life-Sustaining Treatments
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Hsueh-Hsing Pan, PhD, National Defense Medical University
- Päätutkija: Yu-Shiue Lin, National Defense Medical University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- TSGHIRB No. A202305148
- TSGH_E_113274 (Muu apuraha/rahoitusnumero: Tri-Service General Hospital)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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