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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073499
Enrollment
60
Registered
2017-03-08
Start date
2017-01-31
Completion date
2017-04-30
Last updated
2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

PROCEDUREOncological Home Hospitalization

Sponsors

General Hospital Groeninge
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 weeksSensitivity will be analysed by comparing average outcome-scores between
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 weeksSensitivity will be analysed by comparing average outcome-scores between both groups
Sensitivity of the questionnaire HADS to measure anxiety and depression in patients being treated at different ambulatory care settings (hospital vs home)8 weeksSensitivity 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 weeksSensitivity 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 weeksSensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups

Secondary

MeasureTime frameDescription
Costs inventory representing total costs for an ambulant treated cancer patient8 weeksPatients 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026