Cancer
Conditions
Brief summary
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.
Interventions
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.
Sponsors
General Hospital Groeninge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-reported Quality of Life - Cancer specific | Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks | Evaluation of the change of patient-reported quality of life for both study arms using FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire. |
| Change in Patient-reported Quality of Life - General | Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks | Evaluation of the change of patient-reported quality of life for both study arms using EQ-5D (EuroQol 5 dimensions) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost evaluation using study-specific costs questionnaire | 12 weeks | 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. |
| Number of grade 3/4 toxicities according to CTCAE v4.0 | Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks | Evaluation of safety for both study arms, by registrating grade 3/4 toxicities (according to the CTCAE v4.0) during 12 weeks |
| Patient-reported Safety | Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks | Evaluation of patient-reported safety for both study arms, by assessing patients-reported feeling of safety using VAS (Visual analogue scale). |
| Patient-reported Distress | Inquiry at baseline and 12 weeks | Evaluation of distress for both study arms using Distress Barometer (DB). |
| Preference using a self-designed patient-reported questionnaire | Inquiry at baseline and 12 weeks | Evaluation of patients-reported preference for the provided care in both study arms, using a self-designed preference questionnaire. |
| Wait times for administration of treatment at the oncology day care unit. | 12 weeks | 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. |
| Satisfaction using OUT-PATSAT35 CT questionnaire | Inquiry at baseline and 12 weeks | Evaluation of patients-reported satisfaction with the provided care in both study arms, using the Cancer Out-Patient Satisfaction with Care questionnaire (OUT-PATSAT35) . |
| Patient-reported Depression & Anxiety | Inquiry at baseline and 12 weeks | Evaluation of depression and anxiety for both study arms using the hospital anxiety and depression scale (HADS). |
Countries
Belgium
Outcome results
None listed