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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Procedure: Oncological Home Hospitalization

• Registration Number: NCT03073499
• Lead Sponsor: General Hospital Groeninge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Oncological Home Hospitalization	(Partial) Oncological Home Hospitalization

Primary Outcome Measures

Name	Time	Method
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)	8 weeks	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)	8 weeks	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)	8 weeks	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)	8 weeks	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)	8 weeks	Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups

Secondary Outcome Measures

Name	Time	Method
Costs inventory representing total costs for an ambulant treated cancer patient	8 weeks	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.

Trial Locations

Locations (1)

GH Groeninge; 🇧🇪 Kortrijk, West Flanders, Belgium