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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
148
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.
Az Groeninge
Kortrijk, Belgium
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.
Time frame: 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.
Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Patient-reported Distress
Evaluation of distress for both study arms using Distress Barometer (DB).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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) .
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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