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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | (partial) oncological home-hospitalization |
|
| Control | No Intervention | standard oncological ambulatory hospital care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (partial) oncological home-hospitalization | Procedure | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Az Groeninge | Kortrijk | 8500 | Belgium |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| 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 |