Evaluating Quality and Cost of (Partial) Oncological Home-Hospitalization

Cancer Clinical Trial

Official title:

A Single-center, Open Randomized Controlled Clinical Trial to Evaluate the Quality and Cost of (Partial) Oncological Home-hospitalization Compared to Standard Ambulatory Hospital Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668275
• Other study ID #: AZGS2017075
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2020
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oncological home-hospitalization might be a patient-centred, cost-effective approach to deal wiht the current challenges in cancer healthcare.

The primary aim of this clinical trial is to evaluate patient-reported quality of life of patients receiving (partial) oncological home-hospitalization and to compare this outcome with patients receiving standard ambulatory hospital care.

Secondary endpoints that will be evaluated and compared between both randomized groups are:

Quality of life related endpoints (i.e. distress, depression & anxiety and general health-related quality of life); Costs; Safety; patients' reported Satisfaction & Preferences and Efficiency for the hospital day care unit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Starting new oncological treatment at the outpatient hospital

• ECOG = 2

• Living within 30 minutes of drive from the hospital

Exclusion Criteria:

• Important comorbidity (ECOG > 2)

• Life expectancy < 6 months

• Simultaneous treatment with radiotherapy

• Taking part in clinical trial with any Investigational Medicinal Product

• Language barriers or communication difficulties

• Problematic venous access

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• (partial) oncological home-hospitalization
Patients assigned to oncological home-hospitalization will receive as many as possible parts of their oncological treatment at their homes. These include the required preparatory actions before treatment administration is possible and/or the treatment administration itself in case of subcutaneous cancer drugs.

Locations

Country	Name	City	State
Belgium	Az Groeninge	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-reported Quality of Life - Cancer specific	Evaluation of the change of patient-reported quality of life for both study arms using FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire.	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Primary	Change in Patient-reported Quality of Life - General	Evaluation of the change of patient-reported quality of life for both study arms using EQ-5D (EuroQol 5 dimensions) questionnaire.	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Secondary	Patient-reported Distress	Evaluation of distress for both study arms using Distress Barometer (DB).	Inquiry at baseline and 12 weeks
Secondary	Patient-reported Depression & Anxiety	Evaluation of depression and anxiety for both study arms using the hospital anxiety and depression scale (HADS).	Inquiry at baseline and 12 weeks
Secondary	Cost evaluation using study-specific costs questionnaire	Evaluation of healthcare use and related costs for both study arms, using a self-designed costs form in which patients can complete their healthcare use and related expenses during the course of the trial.	12 weeks
Secondary	Number of grade 3/4 toxicities according to CTCAE v4.0	Evaluation of safety for both study arms, by registrating grade 3/4 toxicities (according to the CTCAE v4.0) during 12 weeks	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Secondary	Patient-reported Safety	Evaluation of patient-reported safety for both study arms, by assessing patients-reported feeling of safety using VAS (Visual analogue scale).	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Secondary	Satisfaction using OUT-PATSAT35 CT questionnaire	Evaluation of patients-reported satisfaction with the provided care in both study arms, using the Cancer Out-Patient Satisfaction with Care questionnaire (OUT-PATSAT35) .	Inquiry at baseline and 12 weeks
Secondary	Preference using a self-designed patient-reported questionnaire	Evaluation of patients-reported preference for the provided care in both study arms, using a self-designed preference questionnaire.	Inquiry at baseline and 12 weeks
Secondary	Wait times for administration of treatment at the oncology day care unit.	Evaluation of the efficiency of the workflow at the oncological day care unit for both study arms, by examining the waiting time for treatment administration for each visit of each patient.	12 weeks