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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
General Hospital Groeninge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 7, 2017
Last Updated
March 29, 2018
Sponsor
General Hospital Groeninge
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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

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