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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Procedure: (partial) oncological home-hospitalization

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium, 8500
    • AZ Groeninge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; (partial) oncological home-hospitalization	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.
NO_INTERVENTION: Control; standard oncological ambulatory hospital care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Distress	Evaluation of distress for both study arms using Distress Barometer (DB).	Inquiry at baseline and 12 weeks
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: General Hospital Groeninge

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AZGS2017075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No