Clinical trial NCT06329856: Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan
Official title: Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients and Establishing Clinical Consensus Guideline in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Terminal Cancer
Hospice
Palliative Medicine
Keywords: Artificial hydration
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 1270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From the name list of the Taiwan Academy of Hospice Palliative Medicine and Taiwan Society of Cancer Palliative Medicine

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics
timeFrame: Within 1 month
measure: Distributive statistics
timeFrame: At most 6 months
measure: Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results
timeFrame: Within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Family Medicine, National Taiwan University Hospital
Study officials:
affiliation: Department of Family Medicine, College of Medicine and Hospital, National Taiwan University
name: Shao-Yi Cheng
role: STUDY_CHAIR
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