NCT06329856

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,270

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2024Jul 2026

First Submitted

Initial submission to the registry

March 11, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 14, 2025

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 11, 2024

Last Update Submit

February 12, 2025

Conditions

Keywords

Artificial hydration

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    At most 6 months

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

    Higher scores indicating a worse outcome

    Within 6 months

Study Arms (2)

members of the Taiwan Academy of Hospice Palliative Medicine

members of the Taiwan Academy of Hospice Palliative Medicine

Behavioral: Administering of artificial hydration

members of the Taiwan Society of Cancer Palliative Medicine

members of the Taiwan Society of Cancer Palliative Medicine

Behavioral: Administering of artificial hydration

Interventions

Administering of artificial hydration to terminal cancer patients

members of the Taiwan Academy of Hospice Palliative Medicinemembers of the Taiwan Society of Cancer Palliative Medicine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From the name list of the Taiwan Academy of Hospice Palliative Medicine and Taiwan Society of Cancer Palliative Medicine

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Medicine, National Taiwan University Hospital

Taipei, 100229, Taiwan

RECRUITING

Related Publications (26)

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    PMID: 32900233BACKGROUND
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    PMID: 30922885BACKGROUND
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  • Finkelstein 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.

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  • Morita 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.

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  • Bear 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.

  • Bruera 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.

  • Sato 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.

  • Bruera 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.

  • Nakajima N, Takahashi Y, Ishitani K. The volume of hydration in terminally ill cancer patients with hydration-related symptoms: a prospective study. J Palliat Med. 2014 Sep;17(9):1037-41. doi: 10.1089/jpm.2013.0557. Epub 2014 Jul 22.

  • Wu CY, Chen PJ, Ho TL, Lin WY, Cheng SY. To hydrate or not to hydrate? The effect of hydration on survival, symptoms and quality of dying among terminally ill cancer patients. BMC Palliat Care. 2021 Jan 12;20(1):13. doi: 10.1186/s12904-021-00710-9.

  • Wu CY, Chen PJ, Cheng SY, Suh SY, Huang HL, Lin WY, Hiratsuka Y, Kim SH, Yamaguchi T, Morita T, Tsuneto S, Mori M; EASED Investigators. Association between the amount of artificial hydration and quality of dying among terminally ill patients with cancer: The East Asian Collaborative Cross-Cultural Study to Elucidate the Dying Process. Cancer. 2022 Apr 15;128(8):1699-1708. doi: 10.1002/cncr.34108. Epub 2022 Feb 1.

  • Morita T, Bito S, Koyama H, Uchitomi Y, Adachi I. Development of a national clinical guideline for artificial hydration therapy for terminally ill patients with cancer. J Palliat Med. 2007 Jun;10(3):770-80. doi: 10.1089/jpm.2006.0254.

  • A.S.P.E.N. Ethics Position Paper Task Force; Barrocas A, Geppert C, Durfee SM, Maillet JO, Monturo C, Mueller C, Stratton K, Valentine C; A.S.P.E.N. Board of Directors; American Society for Parenteral and Enteral Nutrition. A.S.P.E.N. ethics position paper. Nutr Clin Pract. 2010 Dec;25(6):672-9. doi: 10.1177/0884533610385429. Epub 2010 Nov 4. No abstract available.

  • Chiu TY, Hu WY, Cheng SY, Chen CY. Ethical dilemmas in palliative care: a study in Taiwan. J Med Ethics. 2000 Oct;26(5):353-7. doi: 10.1136/jme.26.5.353.

  • Chiu TY, Hu WY, Huang HL, Yao CA, Chen CY. Prevailing ethical dilemmas in terminal care for patients with cancer in Taiwan. J Clin Oncol. 2009 Aug 20;27(24):3964-8. doi: 10.1200/JCO.2008.21.4643. Epub 2009 May 26.

  • Huang HL, Yao CA, Hu WY, Cheng SY, Hwang SJ, Chen CD, Lin WY, Lin YC, Chiu TY. Prevailing Ethical Dilemmas Encountered by Physicians in Terminal Cancer Care Changed After the Enactment of the Natural Death Act: 15 Years' Follow-up Survey. J Pain Symptom Manage. 2018 Mar;55(3):843-850. doi: 10.1016/j.jpainsymman.2017.11.033. Epub 2017 Dec 6.

  • Cheng SY, Dy S, Hu WY, Chen CY, Chiu TY. Factors affecting the improvement of quality of dying of terminally ill patients with cancer through palliative care: a ten-year experience. J Palliat Med. 2012 Aug;15(8):854-62. doi: 10.1089/jpm.2012.0033. Epub 2012 Jun 27.

  • Lin CP, Peng JK, Chen PJ, Huang HL, Hsu SH, Cheng SY. Preferences on the Timing of Initiating Advance Care Planning and Withdrawing Life-Sustaining Treatment between Terminally-Ill Cancer Patients and Their Main Family Caregivers: A Prospective Study. Int J Environ Res Public Health. 2020 Oct 29;17(21):7954. doi: 10.3390/ijerph17217954.

  • Ganzini L. Artificial nutrition and hydration at the end of life: ethics and evidence. Palliat Support Care. 2006 Jun;4(2):135-43. doi: 10.1017/s1478951506060196.

Study Officials

  • Shao-Yi Cheng

    Department of Family Medicine, College of Medicine and Hospital, National Taiwan University

    STUDY CHAIR

Central Study Contacts

Shao-Yi Cheng, MD,MSc,DrPH

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 26, 2024

Study Start

August 15, 2024

Primary Completion

December 10, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

February 14, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Anonymous survey and collated data would not reflect individual personal participant data

Locations