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NCT Number: NCT06329856

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a very common practice especially when the terminal cancer patient is 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 exploring the indication and practices of administrating artificial hydration to terminal cancer patients. The questionnaire is mainly 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. A 200 NTD equivalent voucher/gift will be provided to each respondent as an incentive. The investigators will send two follow-up e-mail reminders after two weeks apart. 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.

To reach an 80% response rate, 1270 out of 1589 effective members need to reply to the questionnaire. Basic demographic data will be summarized as total numbers and percentages for categorical variables. Differences in categorical variables will be compared using t-test and Chi-square tests. Cronbach's alpha values of scales are calculated to determine the internal consistency of the scales used. Logistic regressions will be applied to determine factors affecting the administration or withdrawal of artificial hydration.

The second part is to establish a national consensus on clinical guidelines for administering artificial hydration. Taking the questionnaire result as a first-hand reference, the investigators will conduct a modified Delphi method for 6 rounds to reach a final consensus. The investigators will perform literature reviews and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds (Round 2-6) comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median score, and disagreement score according to the Inter-Percentile Range Adjusted for Symmetry. Items with a total of 70% or more panelists voting 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 the consensus guideline will help clinicians to make the appropriate decision from ethical, medical, cultural, and emotional factors and facilitate the cancer patient to achieve a good quality of dying.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Taiwan Academy of Hospice Palliative Medicine
  • Taiwan Society of Cancer Palliative Medicine
  • At least a year in training to take care of terminally ill patients
  • Have signed informed consent.

Exclusion criteria

  • No clinical experience in palliative care
  • Decline to sign informed consent

Treatment and study plan

Administering of artificial hydration

Behavioral

Administering of artificial hydration to terminal cancer patients

Primary outcomes

  1. Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics

    Time frame: Within 1 month

    Multi-factorial and culturally based questionnaire in a nationwide survey of palliative and oncology care specialist, to explore the 5- to 9-point scale of opinion on indication and practices of administrating artificial hydration to terminal cancer patients

  2. Distributive statistics

    Time frame: At most 6 months

    Statistical analyses of quality indicators from 14 sessions of one-to-one interviews and questionnaire surveys among panelists, to be formalized into a consensus guideline when over 70% of panelists voting for a questionnaire item

  3. Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results

    Time frame: Within 6 months

    Higher scores indicating a worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

I Ann Hsiao, MD

CONTACT

[email protected]

+886-2312-3456 ext. 266634

Shao-Yi Cheng, MD,MSc,DrPH

CONTACT

[email protected]

+886-2312-3456 ext. 266823

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients and Establishing Clinical Consensus Guideline in Taiwan

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Mar 26, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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