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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073499
• Other study ID #: GHGroeninge
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: March 29, 2018
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: March 2018
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Oncological Home Hospitalization

Locations

Country	Name	City	State
Belgium	GH Groeninge	Kortrijk	West Flanders

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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