CancerNCT03668275
Evaluating Quality and Cost of (Partial) Oncological Home-Hospitalization
A study testing (partial) oncological home-hospitalization in people with Cancer, run by General Hospital Groeninge at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- (partial) oncological home-hospitalization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Starting new oncological treatment at the outpatient hospital
- ECOG ≤ 2
- Living within 30 minutes of drive from the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Cancer
- Being tested
- (partial) oncological home-hospitalization
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(partial) oncological home-hospitalizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | (partial) oncological home-hospitalization Receives: Procedure: (partial) oncological home-hospitalization |
| Control | No intervention | standard oncological ambulatory hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Secondary outcomes (8)
Patient-reported Distress
Evaluation of distress for both study arms using Distress Barometer (DB).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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) .
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start2 May 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Van Eygen, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668275
- Sponsor's protocol ID
- AZGS2017075
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2017
- Last updated
- 4 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03668275
- Acronym / sponsor ID
- AZGS2017075
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: (partial) oncological home-hospitalization(partial) oncological home-hospitalization |
| Control | No intervention | –standard oncological ambulatory hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Starting new oncological treatment at the outpatient hospital
- ECOG ≤ 2
- Living within 30 minutes of drive from the hospital
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (partial) oncological home-hospitalizationPatients 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. | Procedure or surgery | Intervention |
Primary outcome
Change in Patient-reported Quality of Life - Cancer specific
Time frame: 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
Time frame: 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.
8 secondary outcomes
Patient-reported Distress
Time frame: Inquiry at baseline and 12 weeks
Patient-reported Depression & Anxiety
Time frame: Inquiry at baseline and 12 weeks
Cost evaluation using study-specific costs questionnaire
Time frame: 12 weeks
Number of grade 3/4 toxicities according to CTCAE v4.0
Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Patient-reported Safety
Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Satisfaction using OUT-PATSAT35 CT questionnaire
Time frame: Inquiry at baseline and 12 weeks
Preference using a self-designed patient-reported questionnaire
Time frame: Inquiry at baseline and 12 weeks
Wait times for administration of treatment at the oncology day care unit.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (partial) oncological home-hospitalization in people with Cancer, run by General Hospital Groeninge at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-reported Quality of Life - Cancer specific (time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.