NCT05534178

Brief Summary

The study aims to understand which are the most relevant parameters at admission which may allow to predict the hospital length of stay (HOLS) and mortality after discharge of oncologic hospitalized patients. This is the first multicentric prospective observational study that tries to understand the complexity of the hospitalized oncologic patients. A comprehensive analysis will be performed with the help of the nutrition, nursery, internal medicine and oncology teams.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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 Start

First participant enrolled

February 15, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

March 27, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

HospitalizationOncologic patients

Outcome Measures

Primary Outcomes (2)

  • Predict Mortality

    Mortality at 30-day after discharge

    30 days after discharge

  • Predict hospital length of stay

    Number of days hospitalized

    Through study completion, an average of 3 years

Secondary Outcomes (8)

  • Measure the impact of Anxiety and Depression

    Within 24 hours of admission

  • Measure the impact of Quality of life (QoL)

    Within 24 hours of admission

  • Validate standardized test HOSPITAL score: Risk of readmission

    Evaluated at discharge through study completion, an average of 3 years. The outcome is the probability of readmission within the first 30 days after discharge.

  • Sarcopenia Assessment

    Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years

  • Sarcopenia Test

    Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All oncologic patients that require hospitalization.

You may qualify if:

  • ≥18 years-old.
  • Histological cancer confirmation.
  • Hospitalization in oncology ward.

You may not qualify if:

  • \<18 years-old.
  • Not histological malignancy confirmed.
  • Less than 24 hours in the hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (5)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  • Brooks GA, Cronin AM, Uno H, Schrag D, Keating NL, Mack JW. Intensity of Medical Interventions between Diagnosis and Death in Patients with Advanced Lung and Colorectal Cancer: A CanCORS Analysis. J Palliat Med. 2016 Jan;19(1):42-50. doi: 10.1089/jpm.2015.0190. Epub 2015 Nov 24.

  • Manzano JG, Luo R, Elting LS, George M, Suarez-Almazor ME. Patterns and predictors of unplanned hospitalization in a population-based cohort of elderly patients with GI cancer. J Clin Oncol. 2014 Nov 1;32(31):3527-33. doi: 10.1200/JCO.2014.55.3131. Epub 2014 Oct 6.

  • Earle CC, Park ER, Lai B, Weeks JC, Ayanian JZ, Block S. Identifying potential indicators of the quality of end-of-life cancer care from administrative data. J Clin Oncol. 2003 Mar 15;21(6):1133-8. doi: 10.1200/JCO.2003.03.059.

  • Whitney RL, Bell JF, Tancredi DJ, Romano PS, Bold RJ, Joseph JG. Hospitalization Rates and Predictors of Rehospitalization Among Individuals With Advanced Cancer in the Year After Diagnosis. J Clin Oncol. 2017 Nov 1;35(31):3610-3617. doi: 10.1200/JCO.2017.72.4963. Epub 2017 Aug 29.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Oriol Mirallas, MD

    Vall d'Hebron University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriol Mirallas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2022

First Posted

September 9, 2022

Study Start

February 15, 2020

Primary Completion

February 15, 2023

Study Completion

March 15, 2024

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

IPD will be shared with all the participants of the study

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
1 year
Access Criteria
Principal investigators and sub-investigators

Locations