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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

NCT ID: NCT03073499

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

(Partial) Oncological Home Hospitalization

Group Type EXPERIMENTAL

Oncological Home Hospitalization

Intervention Type PROCEDURE

Control

Standard oncological treatment at the hospital day care unit

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oncological Home Hospitalization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital Groeninge

OTHER

Sponsor Role lead

Responsible Party

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Koen Van Eygen

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koen Van Eygen, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Groeninge

Locations

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GH Groeninge

Kortrijk, West Flanders, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 31229206 (View on PubMed)

Other Identifiers

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GHGroeninge

Identifier Type: -

Identifier Source: org_study_id