Clinical trial NCT03073499: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: 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)
timeFrame: 8 weeks
measure: 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)
timeFrame: 8 weeks
measure: Sensitivity of the questionnaire HADS to measure anxiety and depression in patients being treated at different ambulatory care settings (hospital vs home)
timeFrame: 8 weeks
measure: Sensitivity of the questionnaire Distress Barometer to measure distress in patients being treated at different ambulatory care settings (hospital vs home)
timeFrame: 8 weeks
measure: Sensitivity of a self-designed questionnaire to measure the safety feeling of patients being treated at different ambulatory care settings (hospital vs home)
timeFrame: 8 weeks
Secondary outcomes:
measure: Costs inventory representing total costs for an ambulant treated cancer patient
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: GH Groeninge
state: West Flanders
Study officials:
affiliation: General Hospital Groeninge
name: Koen Van Eygen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.