Admission, Triage, and Discharge Criteria for Oncological Patients in the Intensive Care Unit

NCT07809490 | Not Yet Recruiting

• 1 other identifier: ONCOCCS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will create one agreed set of rules to help doctors decide which people with cancer should be treated in an intensive care unit (ICU), and when they are well enough to leave it. An ICU is a hospital ward for people who are very sick and need close watching and life support. Why the researchers are doing this study Hospitals do not agree on when a person with cancer should go to the ICU. Because of this, some people who could recover are turned away. Others get treatments that cannot help them and may add to their suffering. These choices are harder than for people without cancer. Doctors must weigh the sudden illness, the type of cancer, how well the cancer is responding to treatment, how strong the person is day to day, and what matters most to the person. Cancer care has improved a lot, and many people with cancer now recover well after ICU care. Current rules do not reflect this. How the study will work No new medicine or treatment will be tested, and no patients will take part. Instead, cancer and critical care experts will vote to agree on the rules. This is called a Delphi process. A steering group of 12 to 14 experts will plan the project. They will read the published research and write draft statements about ICU care for people with cancer. The researchers will then invite 30 to 40 experts from around the world to vote on these statements. Participants will be doctors with long experience in cancer care, critical care, or emergency care. Taking part is voluntary. Participants will not know who the other voters are, so no one person can sway the group. Participants will vote in online surveys. They will rate each statement from 1 (strongly disagree) to 7 (strongly agree) and answer some multiple-choice questions. There will be at least three rounds of voting. After each round, participants will see how the group voted as a whole. The steering group will reword statements that did not reach agreement, and participants will vote again. The researchers will count a statement as agreed when about 3 out of 4 participants (75%) vote the same way. For multiple-choice questions, 8 out of 10 participants (80%) must pick the same answer. Statements with very high agreement will use firm wording, such as "should". Statements with lower agreement will use softer wording, such as "may". If participants stay split after repeated rounds, the researchers will report that no recommendation can be made. What the criteria will cover Which people with cancer are likely to benefit from ICU care Who should be treated first when ICU beds are scarce Time-limited trials: when the outcome is unclear, doctors give full ICU care for an agreed short period, then review whether it is helping When and how a person should leave the ICU, whether to a normal ward, to a palliative care unit, or to a hospice Palliative care and hospice care focus on comfort, dignity, and support rather than on curing the cancer. Who is running the study The Onco Critical Care Society is running this project. No company or outside body is paying for it. All experts involved must declare anything that could affect their judgement, such as payments from drug companies. A methods expert will run the surveys and handle the votes so that the results stay fair and private. What happens with the results The researchers expect the work to take about nine months. They will publish the final criteria in a medical journal and share a one-page chart that doctors can use at the bedside. They will also list the questions that research has not yet answered. The rules will be reviewed at least every five years, or sooner if cancer or ICU care changes a great deal. The aim is simple: to help people with cancer get ICU care when it can truly help them, and to spare them care that cannot.

Conditions

Cancer, Critical Care; Cancer Critically Ill

Keywords

onco critical care

Outcome Measures

Primary Outcomes (2)

• Number of candidate consensus statements achieving consensus, defined a priori as a median score ≥5 with ≥75% of panellist votes in the 5-7 range on a 7-point Likert scale

  The unit of measurement is the candidate statement, not the participant. Each candidate statement is voted on by the expert panel using a 7-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = somewhat disagree, 4 = neither agree nor disagree, 5 = somewhat agree, 6 = agree, 7 = strongly agree). Agreement is defined as a score of 5-7 and disagreement as a score of 1-3; a score of 4 is retained in the denominator. Abstentions are excluded from the denominator and reported separately. For each statement and each round, the number and percentage of votes in each response category and the median score are calculated. A statement is classified as having achieved consensus when the median is ≥5 with ≥75% of votes in the 5-7 range (positive consensus), or the median is ≤3 with ≥75% of votes in the 1-3 range (negative consensus). Statements meeting neither criterion are classified as "no consensus." The outcome will be reported as the number of statements achieving consensus out of t

  From closure of Delphi Round 2 to closure of the final Delphi round, an assessment period of up to 3 months (study months 8-10)

• Number of consensus statements meeting the pre-specified stability criterion on chi-square testing of collapsed 7-point Likert response distributions between two consecutive Delphi rounds

  The unit of measurement is the candidate statement. Stability is assessed from Round 2 onwards by comparing the distribution of Likert responses for each statement between two consecutive rounds. To avoid sparse cells at a panel size of 30-40, responses are collapsed into three ordered categories (1-3, 4, 5-7) before non-parametric chi-square testing; Fisher's exact test is substituted where expected cell counts fall below five. A p value \<0.05 indicates instability. A statement is retired from further voting only when it has met the consensus definition in two consecutive rounds. A statement achieving agreement in one round and falling into disagreement in the next is classified as unstable and is revised and re-presented rather than counted as having reached consensus. The outcome will be reported as the number of statements meeting both the consensus and the stability criteria (these constitute the final consensus statements), the number that are stable but without consensus, and

  From closure of Delphi Round 2 to closure of the final Delphi round, an assessment period of up to 3 months (study months 8-10)

Secondary Outcomes (4)

• Number of consensus statements achieving strong consensus, defined as a median score of 6-7 with ≥75% of votes in the 6-7 range on a 7-point Likert scale

  From closure of Delphi Round 1 to closure of the final Delphi round, up to 4 months

• Number of panelists responding in each Delphi round, and per-round response rate calculated as responding panelists divided by panelists invited to that round

  From opening of Delphi Round 1 to closure of the final Delphi round, up to 4 months

• Number of candidate statements added, revised, split, merged, or removed between Delphi rounds following steering committee analysis of panellist free-text responses

  Between closure of each Delphi round and opening of the next, up to 3 months

• Number of clinical questions designated as research priorities, defined as statements failing to reach the pre-specified consensus threshold while demonstrating stable response distributions across two consecutive rounds

  At closure of the final Delphi round, up to 3 months

Study Arms (1)

A cohort of 40 delphi panelist

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

no interventions

A cohort of 40 delphi panelist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 delphi panelist

You may qualify if:

• Aged 18 years or older Clinician, methodologist will be invited to serve as a voting panelist For clinicians: recognized specialist qualification in intensive care medicine, medical oncology, haematology (including haematopoietic cell transplantation or cellular therapy), palliative medicine, emergency medicine.
• For clinicians: at least five years of post-qualification practice involving critically ill adults with cancer Current professional base in one of the six WHO regions Able to complete online questionnaires in English Willing to participate in all planned Delphi rounds and to complete a conflict-of-interest declaration Provides informed consent

You may not qualify if:

• Member of the Steering Committee or the study methodologist (non-voting roles) Unable to commit to the full sequence of Delphi rounds Declared conflict of interest that the Steering Committee judges incompatible with voting Second or subsequent nominee from a country already represented, where the one-panellist-per-co

Sponsors & Collaborators

• Onco Critical Care Society: lead

Study Sites (1)

Max Super specialty Hospital Shalimar bagh

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Related Publications (16)

• van Zuuren EJ, Logullo P, Price A, Fedorowicz Z, Hughes EL, Gattrell WT. Existing guidance on reporting of consensus methodology: a systematic review to inform ACCORD guideline development. BMJ Open. 2022 Sep 8;12(9):e065154. doi: 10.1136/bmjopen-2022-065154.

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• Chang DW, Neville TH, Parrish J, Ewing L, Rico C, Jara L, Sim D, Tseng CH, van Zyl C, Storms AD, Kamangar N, Liebler JM, Lee MM, Yee HF Jr. Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments. JAMA Intern Med. 2021 Jun 1;181(6):786-794. doi: 10.1001/jamainternmed.2021.1000.

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• Quill TE, Holloway R. Time-limited trials near the end of life. JAMA. 2011 Oct 5;306(13):1483-4. doi: 10.1001/jama.2011.1413. No abstract available.

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• Thiery G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Levy V, Fieux F, Moreau D, Le Gall JR, Schlemmer B. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005 Jul 1;23(19):4406-13. doi: 10.1200/JCO.2005.01.487.

  PMID: 15994150 BACKGROUND

• Soares M, Carvalho MS, Salluh JI, Ferreira CG, Luiz RR, Rocco JR, Spector N. Effect of age on survival of critically ill patients with cancer. Crit Care Med. 2006 Mar;34(3):715-21. doi: 10.1097/01.ccm.0000201883.05900.3f.

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• Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.

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• Bird GT, Farquhar-Smith P, Wigmore T, Potter M, Gruber PC. Outcomes and prognostic factors in patients with haematological malignancy admitted to a specialist cancer intensive care unit: a 5 yr study. Br J Anaesth. 2012 Mar;108(3):452-9. doi: 10.1093/bja/aer449. Epub 2012 Jan 31.

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• Lecuyer L, Chevret S, Thiery G, Darmon M, Schlemmer B, Azoulay E. The ICU trial: a new admission policy for cancer patients requiring mechanical ventilation. Crit Care Med. 2007 Mar;35(3):808-14. doi: 10.1097/01.CCM.0000256846.27192.7A.

  PMID: 17235261 BACKGROUND

• Taccone FS, Artigas AA, Sprung CL, Moreno R, Sakr Y, Vincent JL. Characteristics and outcomes of cancer patients in European ICUs. Crit Care. 2009;13(1):R15. doi: 10.1186/cc7713. Epub 2009 Feb 6.

  PMID: 19200368 BACKGROUND

• van Vliet M, Verburg IW, van den Boogaard M, de Keizer NF, Peek N, Blijlevens NM, Pickkers P. Trends in admission prevalence, illness severity and survival of haematological patients treated in Dutch intensive care units. Intensive Care Med. 2014 Sep;40(9):1275-84. doi: 10.1007/s00134-014-3373-x. Epub 2014 Jun 28.

  PMID: 24972886 BACKGROUND

• Soares M, Bozza FA, Azevedo LC, Silva UV, Correa TD, Colombari F, Torelly AP, Varaschin P, Viana WN, Knibel MF, Damasceno M, Espinoza R, Ferez M, Silveira JG, Lobo SA, Moraes AP, Lima RA, de Carvalho AG, do Brasil PE, Kahn JM, Angus DC, Salluh JI. Effects of Organizational Characteristics on Outcomes and Resource Use in Patients With Cancer Admitted to Intensive Care Units. J Clin Oncol. 2016 Sep 20;34(27):3315-24. doi: 10.1200/JCO.2016.66.9549. Epub 2016 Jul 18.

  PMID: 27432921 BACKGROUND

• Azoulay E, Mokart D, Pene F, Lambert J, Kouatchet A, Mayaux J, Vincent F, Nyunga M, Bruneel F, Laisne LM, Rabbat A, Lebert C, Perez P, Chaize M, Renault A, Meert AP, Benoit D, Hamidfar R, Jourdain M, Darmon M, Schlemmer B, Chevret S, Lemiale V. Outcomes of critically ill patients with hematologic malignancies: prospective multicenter data from France and Belgium--a groupe de recherche respiratoire en reanimation onco-hematologique study. J Clin Oncol. 2013 Aug 1;31(22):2810-8. doi: 10.1200/JCO.2012.47.2365. Epub 2013 Jun 10.

  PMID: 23752112 BACKGROUND

• Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.

  PMID: 28190381 BACKGROUND

• Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.

  PMID: 38261576 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Director, Department of Critical Care

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 9, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

IN (1)