A Clinical Trial to Evaluate the Sensitivity of a Number of Clinical and Psychological Outcome Measures for Cancer Patients Being Treated at the Hospital Day Care Unit or (Partially) at Home

Study Overview
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Brief Summary
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This pilot study aims to evaluate the sensitivity, variability and responsiveness of a number of predefined clinical and psychological outcome measuring tools in an ambulant cancer treatment setting (home vs. hospital). The measuring tools will be evaluated in two patient cohorts. One cohort is treated as per standard of care at the outpatient hospital, the other cohort is receiving (partial) cancer treatment at home. A second objective is to create a costs inventory representing total costs for an ambulant treated cancer patient.

Official Title
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A Single-centre, Non-randomized, Prospective, Open Clinical Trial to Evaluate the Sensitivity of a Number of Clinical and Psychological Outcome Measures for Cancer Patients Being Treated at the Hospital Day Care Unit or (Partially) at Home

Conditions
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Cancer

Intervention / Treatment
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* Procedure: 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) Simultaneous radiotherapy treatment Language barriers or communication difficulties Problematic venous access Known problems with administration of the therapy

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: Non-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: Oncological Home Hospitalization<br> <br> |
| No Intervention: Control<br>Standard oncological treatment at the hospital day care unit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |