Evaluating Quality and Cost of (Partial) Oncological Home-Hospitalization

NCT03668275 | Completed

• 1 other identifier: AZGS2017075
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Oncological home-hospitalization might be a patient-centred, cost-effective approach to deal wiht the current challenges in cancer healthcare. The primary aim of this clinical trial is to evaluate patient-reported quality of life of patients receiving (partial) oncological home-hospitalization and to compare this outcome with patients receiving standard ambulatory hospital care. Secondary endpoints that will be evaluated and compared between both randomized groups are: Quality of life related endpoints (i.e. distress, depression \& anxiety and general health-related quality of life); Costs; Safety; patients' reported Satisfaction \& Preferences and Efficiency for the hospital day care unit.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Change in Patient-reported Quality of Life - Cancer specific

  Evaluation of the change of patient-reported quality of life for both study arms using FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire.

  Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

• Change in Patient-reported Quality of Life - General

  Evaluation of the change of patient-reported quality of life for both study arms using EQ-5D (EuroQol 5 dimensions) questionnaire.

  Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (8)

• Patient-reported Distress

  Inquiry at baseline and 12 weeks

• Patient-reported Depression & Anxiety

  Inquiry at baseline and 12 weeks

• Cost evaluation using study-specific costs questionnaire

  12 weeks

• Number of grade 3/4 toxicities according to CTCAE v4.0

  Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

• Patient-reported Safety

  Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

(partial) oncological home-hospitalization

Procedure: (partial) oncological home-hospitalization

Control

NO INTERVENTION

standard oncological ambulatory hospital care

Interventions

(partial) oncological home-hospitalization PROCEDURE

Patients assigned to oncological home-hospitalization will receive as many as possible parts of their oncological treatment at their homes. These include the required preparatory actions before treatment administration is possible and/or the treatment administration itself in case of subcutaneous cancer drugs.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)
• Life expectancy \< 6 months
• Simultaneous treatment with radiotherapy
• Taking part in clinical trial with any Investigational Medicinal Product
• Language barriers or communication difficulties
• Problematic venous access

Sponsors & Collaborators

• General Hospital Groeninge: lead

Study Sites (1)

Az Groeninge

Kortrijk, 8500, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: September 12, 2018
• Study Start: May 2, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)