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Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status changed: Unknown → Completed Final enrollment: 391 participants (planned 1270) · Study completion date changed from estimate of Jul 2026 to Jul 7, 2026 · Eligibility criteria expanded, about 6 words · 2 more Show 5 more changesShow less
    • Final enrollment: 391 participants (planned 1270)
    • Study completion date changed from estimate of Jul 2026 to Jul 7, 2026
    • Eligibility criteria expanded, about 6 words
    • Site details revised
    • Publications: details revised at 25 of 26 entries
  2. Minor Changed Registry marked status Unknown; last known: Recruiting
  3. Minor Trial status: Recruiting to Unknown Primary completion date changed from estimate of Oct 2024 to Dec 10, 2024v3 Show 1 more changeShow less
    • Primary completion date changed from estimate of Oct 2024 to Dec 10, 2024
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2024 to Aug 15, 2024 · Study sites: 0 to 1 · Primary completion date: Jul 2024 to Oct 2024v2 Show 3 more changesShow less
    • Start date changed from estimate of Apr 2024 to Aug 15, 2024
    • Study sites: 0 to 1
    • Primary completion date: Jul 2024 to Oct 2024
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a common practice especially when patients are incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan. Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists with a questionnaire designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration. The second part is to establish a national consensus on clinical guidelines for administering artificial hydration, where the investigators will conduct a modified Delphi method for 6 rounds. Literature reviews will be first performed and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median and disagreement scores according to the Inter-Percentile Range Adjusted for Symmetry. Items voted for by 70% or more panelists will be selected and formalized into a consensus guideline. Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based. Conclusion: The establishment of a consensus guideline will help clinicians to make an appropriate decision from ethical, medical, cultural, and emotional factors and facilitate cancer patients to achieve a good quality of dying.
Trial Details
NCT Number NCT06329856
Lead Sponsor National Taiwan University Hospital
Conditions Terminal Cancer, Hospice, Palliative Medicine
Enrollment 391 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov