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NCT Number: NCT03668275

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Az Groeninge

Kortrijk, 8500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

(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.

Primary outcomes

  1. Change in Patient-reported Quality of Life - Cancer specific

    Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

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

  2. Change in Patient-reported Quality of Life - General

    Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

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

Secondary outcomes

  1. Patient-reported Distress

    Time frame: Inquiry at baseline and 12 weeks

    Evaluation of distress for both study arms using Distress Barometer (DB).

  2. Patient-reported Depression & Anxiety

    Time frame: Inquiry at baseline and 12 weeks

    Evaluation of depression and anxiety for both study arms using the hospital anxiety and depression scale (HADS).

  3. Cost evaluation using study-specific costs questionnaire

    Time frame: 12 weeks

    Evaluation of healthcare use and related costs for both study arms, using a self-designed costs form in which patients can complete their healthcare use and related expenses during the course of the trial.

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

    Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

    Evaluation of safety for both study arms, by registrating grade 3/4 toxicities (according to the CTCAE v4.0) during 12 weeks

  5. Patient-reported Safety

    Time frame: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks

    Evaluation of patient-reported safety for both study arms, by assessing patients-reported feeling of safety using VAS (Visual analogue scale).

  6. Satisfaction using OUT-PATSAT35 CT questionnaire

    Time frame: Inquiry at baseline and 12 weeks

    Evaluation of patients-reported satisfaction with the provided care in both study arms, using the Cancer Out-Patient Satisfaction with Care questionnaire (OUT-PATSAT35) .

  7. Preference using a self-designed patient-reported questionnaire

    Time frame: Inquiry at baseline and 12 weeks

    Evaluation of patients-reported preference for the provided care in both study arms, using a self-designed preference questionnaire.

  8. Wait times for administration of treatment at the oncology day care unit.

    Time frame: 12 weeks

    Evaluation of the efficiency of the workflow at the oncological day care unit for both study arms, by examining the waiting time for treatment administration for each visit of each patient.

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Registry information

Official study title

A Single-center, Open Randomized Controlled Clinical Trial to Evaluate the Quality and Cost of (Partial) Oncological Home-hospitalization Compared to Standard Ambulatory Hospital Care

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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