NCT03073499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

February 7, 2017

Last Update Submit

March 29, 2018

Conditions

Cancer

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Costs inventory representing total costs for an ambulant treated cancer patient

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

(Partial) Oncological Home Hospitalization

Procedure: Oncological Home Hospitalization

Control

NO INTERVENTION

Standard oncological treatment at the hospital day care unit

Interventions

Oncological Home HospitalizationPROCEDURE
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Starting new oncological treatment at the outpatient hospital.
  • ECOG ≤ 2
  • Living within 30 minutes of drive from the hospital

You may not qualify if:

  • Important comorbidity (ECOG \> 2)
  • Simultaneous radiotherapy treatment
  • Language barriers or communication difficulties
  • Problematic venous access
  • Known problems with administration of the therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GH Groeninge

Kortrijk, West Flanders, 8500, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 31229206DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Koen Van Eygen, MD

    General Hospital Groeninge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 7, 2017

First Posted

March 8, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)