Quality of Life Clinical Trial
— PLANTOLOGYOfficial 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
NCT number | NCT05534178 |
Other study ID # | VHIO1601 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 15, 2020 |
Est. completion date | March 15, 2024 |
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.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | March 15, 2024 |
Est. primary completion date | February 15, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years-old. - Histological cancer confirmation. - Hospitalization in oncology ward. Exclusion Criteria: - <18 years-old. - Not histological malignancy confirmed. - Less than 24 hours in the hospital. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Vall d'Hebron Institute of Oncology | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital del Mar |
Spain,
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 — View Citation
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. Review. — View Citation
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 2 — View Citation
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/caa — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predict Mortality | Mortality at 30-day after discharge | 30 days after discharge | |
Primary | Predict hospital length of stay | Number of days hospitalized | Through study completion, an average of 3 years | |
Secondary | 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) | Within 24 hours of admission | |
Secondary | Measure the impact of Quality of life (QoL) | EORTC QLQ-C30 Minimum: 30 Maximum: 126. More punctuation, worse QoL | Within 24 hours of admission | |
Secondary | 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. | 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. | |
Secondary | 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. | Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years | |
Secondary | 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. | Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years | |
Secondary | Nutrition Assessment | Intake compliance of food served (100%, 75%, 50%, 25% and 0% of the food served in each meal. | Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years | |
Secondary | Opioids Intake | Quantity of morphine equivalent in mg per day at admission and at discharge | Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years | |
Secondary | 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. | Within 24 hours of admission through study completion, an average of 3 years |
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