Terminal CancerNCT06329856
Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan
An observational study of Terminal Cancer and Hospice, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Terminal Cancer, Hospice, Palliative Medicine
- What is being tested?
- Administering of artificial hydration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 391 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2024to 7 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: From the name list of the Taiwan Academy of Hospice Palliative Medicine and Taiwan Society of Cancer Palliative Medicine
Who may be able to join
- 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.
Who cannot join
- No clinical experience in palliative care
- Decline to sign informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Family Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100229
About this study
Official title: Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients and Establishing Clinical Consensus Guideline 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.
Read more
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.
Read the 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.
- Conditions
- Terminal Cancer, Hospice, Palliative Medicine
- Being tested
- Administering of artificial hydration
- Keywords
- Artificial hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administering of artificial hydrationBehavioural
Administering of artificial hydration to terminal cancer patients
| Study group | Role | What they receive |
|---|---|---|
| members of the Taiwan Academy of Hospice Palliative Medicine | members of the Taiwan Academy of Hospice Palliative Medicine Receives: Behavioral: Administering of artificial hydration | |
| members of the Taiwan Society of Cancer Palliative Medicine | members of the Taiwan Society of Cancer Palliative Medicine Receives: Behavioral: Administering of artificial hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics
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
Measured: Within 1 month
Distributive statistics
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
Measured: At most 6 months
Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results
Higher scores indicating a worse outcome
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start15 Aug 2024
- Primary completion10 Dec 2024
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Terminal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Yi Cheng, Study chair, Department of Family Medicine, College of Medicine and Hospital, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329856
- Sponsor's protocol ID
- 202301218RIND
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous survey and collated data would not reflect individual personal participant data
Publications
Chang YK, Kaplan H, Geng Y, Mo L, Philip J, Collins A, Allen LA, McClung JA, Denvir MA, Hui D. Referral Criteria to Palliative Care for Patients With Heart Failure: A Systematic Review. Circ Heart Fail. 2020 Sep;13(9):e006881. doi: 10.1161/CIRCHEARTFAILURE.120.006881. Epub 2020 Sep 9.
PubMed 32900233De Meyer D, Kottner J, Beele H, Schmitt J, Lange T, Van Hecke A, Verhaeghe S, Beeckman D. Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection. J Clin Epidemiol. 2019 Jul;111:23-31. doi: 10.1016/j.jclinepi.2019.03.011. Epub 2019 Mar 25.
PubMed 30922885Cheng SY, Lin CP, Chan HY, Martina D, Mori M, Kim SH, Ng R. Advance care planning in Asian culture. Jpn J Clin Oncol. 2020 Sep 5;50(9):976-989. doi: 10.1093/jjco/hyaa131.
PubMed 32761078Finkelstein EA, Bhadelia A, Goh C, Baid D, Singh R, Bhatnagar S, Connor SR. Cross Country Comparison of Expert Assessments of the Quality of Death and Dying 2021. J Pain Symptom Manage. 2022 Apr;63(4):e419-e429. doi: 10.1016/j.jpainsymman.2021.12.015. Epub 2021 Dec 22.
PubMed 34952169Welk TA. Clinical and ethical considerations of fluid and electrolyte management in the terminally ill client. J Intraven Nurs. 1999 Jan-Feb;22(1):43-7.
PubMed 10335177Schmidlin E. Artificial hydration: the role of the nurse in addressing patient and family needs. Int J Palliat Nurs. 2008 Oct;14(10):485-9. doi: 10.12968/ijpn.2008.14.10.31492.
PubMed 18978694Torres-Vigil I, Cohen MZ, de la Rosa A, Cardenas-Turanzas M, Burbach BE, Tarleton KW, Shen WM, Bruera E. Food or medicine: ethnic variations in perceptions of advanced cancer patients and their caregivers regarding artificial hydration during the last weeks of life. BMJ Support Palliat Care. 2012 Sep;2(3):276-9. doi: 10.1136/bmjspcare-2012-000205. Epub 2012 Jul 23.
PubMed 24654201Morita T, Tei Y, Inoue S. Agitated terminal delirium and association with partial opioid substitution and hydration. J Palliat Med. 2003 Aug;6(4):557-63. doi: 10.1089/109662103768253669.
PubMed 14516497Morita T, Shima Y, Miyashita M, Kimura R, Adachi I; Japan Palliative Oncology Study Group. Physician- and nurse-reported effects of intravenous hydration therapy on symptoms of terminally ill patients with cancer. J Palliat Med. 2004 Oct;7(5):683-93. doi: 10.1089/jpm.2004.7.683.
PubMed 15588360Morita T, Hyodo I, Yoshimi T, Ikenaga M, Tamura Y, Yoshizawa A, Shimada A, Akechi T, Miyashita M, Adachi I; Japan Palliative Oncology Study Group. Association between hydration volume and symptoms in terminally ill cancer patients with abdominal malignancies. Ann Oncol. 2005 Apr;16(4):640-7. doi: 10.1093/annonc/mdi121. Epub 2005 Jan 31.
PubMed 15684225Morita T, Hyodo I, Yoshimi T, Ikenaga M, Tamura Y, Yoshizawa A, Shimada A, Akechi T, Miyashita M, Adachi I; Japan Palliative Oncology Study Group. Artificial hydration therapy, laboratory findings, and fluid balance in terminally ill patients with abdominal malignancies. J Pain Symptom Manage. 2006 Feb;31(2):130-9. doi: 10.1016/j.jpainsymman.2005.06.015.
PubMed 16488346Bear AJ, Bukowy EA, Patel JJ. Artificial Hydration at the End of Life. Nutr Clin Pract. 2017 Oct;32(5):628-632. doi: 10.1177/0884533617724741. Epub 2017 Aug 16.
PubMed 28813202Bruera E, Belzile M, Watanabe S, Fainsinger RL. Volume of hydration in terminal cancer patients. Support Care Cancer. 1996 Mar;4(2):147-50. doi: 10.1007/BF01845764.
PubMed 8673352Sato K, Miyashita M, Morita T, Tsuneto S, Shima Y. End-of-Life Medical Treatments in the Last Two Weeks of Life in Palliative Care Units in Japan, 2005-2006: A Nationwide Retrospective Cohort Survey. J Palliat Med. 2016 Nov;19(11):1188-1196. doi: 10.1089/jpm.2016.0108. Epub 2016 Jul 27.
PubMed 27463530Bruera E, Hui D, Dalal S, Torres-Vigil I, Trumble J, Roosth J, Krauter S, Strickland C, Unger K, Palmer JL, Allo J, Frisbee-Hume S, Tarleton K. Parenteral hydration in patients with advanced cancer: a multicenter, double-blind, placebo-controlled randomized trial. J Clin Oncol. 2013 Jan 1;31(1):111-8. doi: 10.1200/JCO.2012.44.6518. Epub 2012 Nov 19.
PubMed 23169523