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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Procedure: Oncological Home Hospitalization

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • West Flanders
    • Kortrijk, West Flanders, Belgium, 8500
      • GH Groeninge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; (Partial) Oncological Home Hospitalization	Procedure: Oncological Home Hospitalization
No Intervention: Control; Standard oncological treatment at the hospital day care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks
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	8 weeks
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	8 weeks
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	8 weeks
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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: General Hospital Groeninge
• Investigators: Principal Investigator: Koen Van Eygen, MD, General Hospital Groeninge

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: GHGroeninge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No