A Clinical Trial to Evaluate the Sensitivity of a Number... | NCT03073499

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	(Partial) Oncological Home Hospitalization	Procedure: Oncological Home Hospitalization
Control	No Intervention	Standard oncological treatment at the hospital day care unit

Name	Type	Description	Arm Group Labels	Other Names
Oncological Home Hospitalization	Procedure		Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of the questionnaires FACT-G, EQ-5D and MYCaW to measure quality of life in patients being treated at different ambulatory care settings (hospital vs home)	Sensitivity will be analysed by comparing average outcome-scores between both groups	8 weeks
Sensitivity of the questionnaire OUT-PATSAT35 to measure satisfaction with the provided care of patients being treated at different ambulatory care settings (hospital vs home)	Sensitivity will be analysed by comparing average outcome-scores between	8 weeks
Sensitivity of the questionnaire HADS to measure anxiety and depression in patients being treated at different ambulatory care settings (hospital vs home)	Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups	8 weeks
Sensitivity of the questionnaire Distress Barometer to measure distress in patients being treated at different ambulatory care settings (hospital vs home)	Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups	8 weeks
Sensitivity of a self-designed questionnaire to measure the safety feeling of patients being treated at different ambulatory care settings (hospital vs home)	Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Costs inventory representing total costs for an ambulant treated cancer patient	Patients will be asked to record their medical consumptions during the first 8 weeks of treatment using a costs form. Furthermore, also hospital financial data wil be implemented in the costs inventory.	8 weeks

Eligibility Module

Name	Affiliation	Role
Koen Van Eygen, MD	General Hospital Groeninge	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
GH Groeninge		Kortrijk	West Flanders	8500	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31229206	Derived	Cool L, Missiaen J, Vandijck D, Lefebvre T, Lycke M, De Jonghe PJ, Vergauwe P, Foulon V, Pottel H, Debruyne P, Van Eygen K. An observational pilot study to evaluate the feasibility and quality of oncological home-hospitalization. Eur J Oncol Nurs. 2019 Jun;40:44-52. doi: 10.1016/j.ejon.2019.03.003. Epub 2019 Mar 23.