Solid TumorPLANTOLOGYNCT05534178
Machine Learning Model to Predict HOLS and Mortality After Discharge in Hospitalized Oncologic Patients
An observational study of Solid Tumor and Nutrition Related Neoplasm/Cancer, run by Vall d'Hebron Institute of Oncology at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Nutrition Related Neoplasm/Cancer, Comorbidities and Coexisting Conditions
- How many people
- 2,500 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Feb 2020to 15 Mar 2024
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: All oncologic patients that require hospitalization.
Who may be able to join
- ≥18 years-old.
- Histological cancer confirmation.
- Hospitalization in oncology ward.
Who cannot join
- <18 years-old.
- Not histological malignancy confirmed.
- Less than 24 hours in the hospital.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Jordi Recuero, MD, jordi.recuero.borau@gmail.com
Jordi Recuero, MD
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Oriol Mirallas, MD, 934 89 30 00, omirallas@vhebron.net
Clara Salva, MD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Berta Martin Cullell, MD, +34935565638, bmartinc@santpau.cat
David Paez, MD, dpaez@santpau.cat
About this study
Official title: Machine Learning Model to Predict Hospital Length of Stay (HOLS) and Mortality After Discharge in Hospitalized Oncologic Patients [Plantology Database]: a Multicenter Cross-validation Study
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.
Read the detailed description
BACKGROUND:
Cancer is the second leading cause of death worldwide and is responsible for about 18.1 million new cases and 9.6 million deaths in 2018 alone according to the International Agency for Research on Cancer. Cancer is anticipated to rank as the leading cause of death and the most important barrier to increasing life expectancy in every country of the world in the mid-21st century1. The economic impact of cancer is significant. The annual economic cost of cancer in 2010 was estimated at approximately US$ 1.16 trillion. The reasons are complex but both cancer incidence and mortality are increasing worldwide due to aging and increasing risk factors for cancer, several of which are associated with socioeconomic development. Cancer will probably soon reach the top leading cause of death due to the rapid population growth and the declines in mortality rates by stroke or coronary heart disease in many developed countries.
Cancer patients often require inpatient care due to treatment toxicities, complications from cancer such as thrombosis, illness not related to the disease itself or terminally ill patients. Among these individuals, their treatment should balance prolongation of survival and maximization of the quality of remaining life. However, hospitalization is a stressful event for individuals with advanced cancer and their caregivers. Hospitalization often antagonizes these goals, contributing to the high cost of cancer care, worsens survival, and is increasingly recognized as poor-quality cancer care. Thus, interventions that reduce unnecessary hospitalizations, or shorten them, will likely improve quality of life and reduce costs.
Some studies relate malnutrition, which presents a marked sarcopenia and loss of lean mass, with prolonged hospitalization, reduced response to treatment, a worse overall survival and impaired quality of life. A study published in 2007 found that lung cancer patients had a longer hospitalization and required inpatient hospital treatment more frequently than any other type of tumor. Moreover, in the surgical setting there have been studies linking preoperative opioid usage and increased opioid doses with increased length of stay. Based on this data, there have been protocols developed like the ERAS (Enhanced recovery after surgery) applied first to colorectal cancer and now being tested in other settings like head and neck and gynecologic tumors, showing that it is possible to reduce opioid use with good pain control and a statistically significant shorter average length of stay.
Prognostic factors for oncologic patients after surgery or curative systemic treatment have been described, but there is no solid evidence on which combination of parameters predict mortality after hospitalization of metastatic cancer patients under active treatment. A potential solution to improve this scenario might be nutritional support to malnourished cancer patients that also has proven to be effective in shorten hospital stay and improve survival, or community based palliative care interventions that are proven to improve quality of life and reduce costs of terminally ill patients. Thus, a prognostic tool would be useful to help physicians adjust medical interventions for hospitalized cancer patients.
To the best of our knowledge, this is the first study that examines independent clinical, psychological, nutritional status, and laboratory characteristics of oncologic patients in order to grasp a comprehensive picture of what factors play a role in the length of stay, mortality, and quality of life.
MEANING The investigators pretend with this work to fill a gap of knowledge in the oncology field through a prospective study. The investigators would like to measure the effect of hospitalization on oncologic patients after discharge and how clinical and laboratory parameters at admission may be able to predict HOLS and 30-day mortality after discharge. The investigators would also like to validate the different scales already published to assess nutritional status, psychological status, quality of life or prediction of rehospitalization for oncologic patients in all-in-one study.
This study will hopefully be able to develop a predictive tool at admission to help physicians adjust medical interventions and detect possible actions that will need to be implemented during hospitalization in order to improve the overall survival and quality of life of our patients.
- Conditions
- Solid Tumor, Nutrition Related Neoplasm/Cancer, Comorbidities and Coexisting Conditions, Mental Status Change, Artificial Intelligence, Oncology
- Keywords
- Hospitalization, Oncologic patients
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict Mortality
Mortality at 30-day after discharge
Measured: 30 days after discharge
Predict hospital length of stay
Number of days hospitalized
Measured: Through study completion, an average of 3 years
Secondary outcomes (8)
Measure the impact of Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). Minimum: 0 Maximum: 21. More than 12 points is clinical significant for depression or anxiety [0-7 = Normal; 8-10 = Borderline; abnormal (borderline case)] 11-21 = Abnormal (case)
Measured: Within 24 hours of admission
Measure the impact of Quality of life (QoL)
EORTC QLQ-C30 Minimum: 30 Maximum: 126. More punctuation, worse QoL
Measured: Within 24 hours of admission
Validate standardized test HOSPITAL score: Risk of readmission
HOSPITAL Score; higher score, more risk of readmission. Min: 0 points. Max: 13 points. Measures: Risk of potentially avoidable 30-day readmission.
Measured: 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
Chair test is performed by the number of stands a person can complete in 30 seconds. Results depend on sex and age, the more the better and screens for sarcopenia.
Measured: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Sarcopenia Test
Hand grip test; the more power the better using a hand-held dynamometer. It screens for sarcopenia. A poor performance is 20 to 22kg of power, a below average performance is 23 to 35kg of power, an average performance is 26 to 29kg of power, and an above average performance is 30 to 33kg of power.
Measured: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Nutrition Assessment
Intake compliance of food served (100%, 75%, 50%, 25% and 0% of the food served in each meal.
Measured: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Opioids Intake
Quantity of morphine equivalent in mg per day at admission and at discharge
Measured: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Tumor Characteristics and Comorbidities
Tumor type, oncologic treatment during the last 6 months, comorbidities measured through the Charlson score (Age, <50years 0 points, 50-59years 1 point, 60-69 years 2 points, 70-79 years 3 points, =>80 years, 4 points, Prior myocardial infarction 1 point; congestive heart failure 1 point; peripheral vascular disease 1point; Cerebrovascular disease 1 point; Dementia 1 point; Chronic pulmonary disease 1 point; Rheumatologic disease 1 point; Peptic ulcer disease 1 point; Mild liver disease 1 point; Diabetes 1 point; Cerebrovascular (hemiplegia)event 2 points; Moderate-to-severe renal disease 2 points; Cancer without metastases 2 points; Leukemia 2 points; Lymphoma 2 points; Moderate to severe liver disease 3 points; Metastatic Solid tumor 6 points; Acquired immune deficiency syndrome (AIDS; 6 points). Max 37 points. Min 0 points. The higher the score, the more comorbidities and worse survival.
Measured: Within 24 hours of admission through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start15 Feb 2020
- Primary completion15 Feb 2023 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital del Mar
- Responsible party
- Principal investigator, Oriol Mirallas, Vall d'Hebron Institute of Oncology
- Investigators
- Oriol Mirallas, MD, Principal investigator, Vall d'Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534178
- Sponsor's protocol ID
- VHIO1601
- Acronym
- PLANTOLOGY
- Status last verified
- Sep 2022
- First submitted
- 27 Mar 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with all the participants of the study
Publications
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.
PubMed 33538338Brooks 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.
PubMed 26600474Manzano 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.
PubMed 25287830Earle 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.
PubMed 12637481Whitney 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.
PubMed 28850290
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Model to Predict Hospital Length of Stay (HOLS) and Mortality After Discharge in Hospitalized Oncologic Patients [Plantology Database]: a Multicenter Cross-validation Study
- ClinicalTrials.gov ID
- NCT05534178
- Acronym / sponsor ID
- PLANTOLOGY / VHIO1601
- Conditions
- Solid Tumor, Nutrition Related Neoplasm/Cancer, Comorbidities and Coexisting Conditions, Mental Status Change, Artificial Intelligence, Oncology
- Keywords
- Hospitalization, Oncologic patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital del Mar
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Cancer is the second leading cause of death worldwide and is responsible for about 18.1 million new cases and 9.6 million deaths in 2018 alone according to the International Agency for Research on Cancer. Cancer is anticipated to rank as the leading cause of death and the most important barrier to increasing life expectancy in every country of the world in the mid-21st century1. The economic impact of cancer is significant. The annual economic cost of cancer in 2010 was estimated at approximately US$ 1.16 trillion. The reasons are complex but both cancer incidence and mortality are increasing worldwide due to aging and increasing risk factors for cancer, several of which are associated with socioeconomic development. Cancer will probably soon reach the top leading cause of death due to the rapid population growth and the declines in mortality rates by stroke or coronary heart disease in many developed countries.
Cancer patients often require inpatient care due to treatment toxicities, complications from cancer such as thrombosis, illness not related to the disease itself or terminally ill patients. Among these individuals, their treatment should balance prolongation of survival and maximization of the quality of remaining life. However, hospitalization is a stressful event for individuals with advanced cancer and their caregivers. Hospitalization often antagonizes these goals, contributing to the high cost of cancer care, worsens survival, and is increasingly recognized as poor-quality cancer care. Thus, interventions that reduce unnecessary hospitalizations, or shorten them, will likely improve quality of life and reduce costs.
Some studies relate malnutrition, which presents a marked sarcopenia and loss of lean mass, with prolonged hospitalization, reduced response to treatment, a worse overall survival and impaired quality of life. A study published in 2007 found that lung cancer patients had a longer hospitalization and required inpatient hospital treatment more frequently than any other type of tumor. Moreover, in the surgical setting there have been studies linking preoperative opioid usage and increased opioid doses with increased length of stay. Based on this data, there have been protocols developed like the ERAS (Enhanced recovery after surgery) applied first to colorectal cancer and now being tested in other settings like head and neck and gynecologic tumors, showing that it is possible to reduce opioid use with good pain control and a statistically significant shorter average length of stay.
Prognostic factors for oncologic patients after surgery or curative systemic treatment have been described, but there is no solid evidence on which combination of parameters predict mortality after hospitalization of metastatic cancer patients under active treatment. A potential solution to improve this scenario might be nutritional support to malnourished cancer patients that also has proven to be effective in shorten hospital stay and improve survival, or community based palliative care interventions that are proven to improve quality of life and reduce costs of terminally ill patients. Thus, a prognostic tool would be useful to help physicians adjust medical interventions for hospitalized cancer patients.
To the best of our knowledge, this is the first study that examines independent clinical, psychological, nutritional status, and laboratory characteristics of oncologic patients in order to grasp a comprehensive picture of what factors play a role in the length of stay, mortality, and quality of life.
MEANING The investigators pretend with this work to fill a gap of knowledge in the oncology field through a prospective study. The investigators would like to measure the effect of hospitalization on oncologic patients after discharge and how clinical and laboratory parameters at admission may be able to predict HOLS and 30-day mortality after discharge. The investigators would also like to validate the different scales already published to assess nutritional status, psychological status, quality of life or prediction of rehospitalization for oncologic patients in all-in-one study.
This study will hopefully be able to develop a predictive tool at admission to help physicians adjust medical interventions and detect possible actions that will need to be implemented during hospitalization in order to improve the overall survival and quality of life of our patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All oncologic patients that require hospitalization.
Key inclusion criteria (3 listed)
- ≥18 years-old.
- Histological cancer confirmation.
- Hospitalization in oncology ward.
Key exclusion criteria (3 listed)
- <18 years-old.
- Not histological malignancy confirmed.
- Less than 24 hours in the hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predict Mortality
Time frame: 30 days after discharge
Mortality at 30-day after discharge
Predict hospital length of stay
Time frame: Through study completion, an average of 3 years
Number of days hospitalized
8 secondary outcomes
Measure the impact of Anxiety and Depression
Time frame: Within 24 hours of admission
Measure the impact of Quality of life (QoL)
Time frame: Within 24 hours of admission
Validate standardized test HOSPITAL score: Risk of readmission
Time frame: 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
Time frame: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Sarcopenia Test
Time frame: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Nutrition Assessment
Time frame: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Opioids Intake
Time frame: Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years
Tumor Characteristics and Comorbidities
Time frame: Within 24 hours of admission through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Results publication: PubMed 33538338Sung 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.
- Results publication: PubMed 26600474Brooks 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.
- Results publication: PubMed 25287830Manzano 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.
- Results publication: PubMed 12637481Earle 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.
- Results publication: PubMed 28850290Whitney 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.
- Individual participant dataSharing planned: Yes. IPD will be shared with all the participants of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriol Mirallas, MD principal investigator
Vall d'Hebron University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Nutrition Related Neoplasm/Cancer, run by Vall d'Hebron Institute of Oncology at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oriol Mirallas, MD (+34934 89 30 00, omirallas@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict Mortality (time frame: 30 days after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534178, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022; AzTrials last refreshed its copy on 27 Oct 2026.