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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Procedure: (partial) oncological home-hospitalization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>(partial) oncological home-hospitalization | Procedure: (partial) oncological home-hospitalization<br>* 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.<br>|
| No Intervention: Control<br>standard oncological ambulatory hospital care | |

What is the study measuring?
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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 |