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
Primary Purpose
Cancer
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Oncological Home Hospitalization
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer
Eligibility Criteria
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
Sites / Locations
- GH Groeninge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
(Partial) Oncological Home Hospitalization
Standard oncological treatment at the hospital day care unit
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03073499
First Posted
February 7, 2017
Last Updated
March 29, 2018
Sponsor
General Hospital Groeninge
1. Study Identification
Unique Protocol Identification Number
NCT03073499
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Groeninge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
(Partial) Oncological Home Hospitalization
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard oncological treatment at the hospital day care unit
Intervention Type
Procedure
Intervention Name(s)
Oncological Home Hospitalization
Primary Outcome Measure Information:
Title
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)
Description
Sensitivity will be analysed by comparing average outcome-scores between both groups
Time Frame
8 weeks
Title
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)
Description
Sensitivity will be analysed by comparing average outcome-scores between
Time Frame
8 weeks
Title
Sensitivity of the questionnaire HADS to measure anxiety and depression in patients being treated at different ambulatory care settings (hospital vs home)
Description
Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups
Time Frame
8 weeks
Title
Sensitivity of the questionnaire Distress Barometer to measure distress in patients being treated at different ambulatory care settings (hospital vs home)
Description
Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups
Time Frame
8 weeks
Title
Sensitivity of a self-designed questionnaire to measure the safety feeling of patients being treated at different ambulatory care settings (hospital vs home)
Description
Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Costs inventory representing total costs for an ambulant treated cancer patient
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Van Eygen, MD
Organizational Affiliation
General Hospital Groeninge
Official's Role
Principal Investigator
Facility Information:
Facility Name
GH Groeninge
City
Kortrijk
State/Province
West Flanders
ZIP/Postal Code
8500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31229206
Citation
Cool L, Missiaen J, Vandijck D, Lefebvre T, Lycke M, De Jonghe PJ, Vergauwe P, Foulon V, Pottel H, Debruyne P, Van Eygen K. An observational pilot study to evaluate the feasibility and quality of oncological home-hospitalization. Eur J Oncol Nurs. 2019 Jun;40:44-52. doi: 10.1016/j.ejon.2019.03.003. Epub 2019 Mar 23.
Results Reference
derived
Learn more about this trial
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
We'll reach out to this number within 24 hrs