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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Procedure: (partial) oncological home-hospitalization

• Registration Number: NCT03668275
• Lead Sponsor: General Hospital Groeninge

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-16
• Study Start: 2018-05-02
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	(partial) oncological home-hospitalization	(partial) oncological home-hospitalization

Primary Outcome Measures

Name	Time	Method
Change in Patient-reported Quality of Life - Cancer specific	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks	Evaluation of the change of patient-reported quality of life for both study arms using FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire.
Change in Patient-reported Quality of Life - General	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks	Evaluation of the change of patient-reported quality of life for both study arms using EQ-5D (EuroQol 5 dimensions) questionnaire.

Secondary Outcome Measures

Name	Time	Method
Number of grade 3/4 toxicities according to CTCAE v4.0	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks	Evaluation of safety for both study arms, by registrating grade 3/4 toxicities (according to the CTCAE v4.0) during 12 weeks
Patient-reported Distress	Inquiry at baseline and 12 weeks	Evaluation of distress for both study arms using Distress Barometer (DB).
Preference using a self-designed patient-reported questionnaire	Inquiry at baseline and 12 weeks	Evaluation of patients-reported preference for the provided care in both study arms, using a self-designed preference questionnaire.
Cost evaluation using study-specific costs questionnaire	12 weeks	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.
Wait times for administration of treatment at the oncology day care unit.	12 weeks	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.
Patient-reported Depression & Anxiety	Inquiry at baseline and 12 weeks	Evaluation of depression and anxiety for both study arms using the hospital anxiety and depression scale (HADS).
Patient-reported Safety	Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks	Evaluation of patient-reported safety for both study arms, by assessing patients-reported feeling of safety using VAS (Visual analogue scale).
Satisfaction using OUT-PATSAT35 CT questionnaire	Inquiry at baseline and 12 weeks	Evaluation of patients-reported satisfaction with the provided care in both study arms, using the Cancer Out-Patient Satisfaction with Care questionnaire (OUT-PATSAT35) .

Trial Locations

Locations (1)

Az Groeninge; 🇧🇪 Kortrijk, Belgium