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NCT Number: 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

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.

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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

GH Groeninge

Kortrijk, West Flanders, 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)
  • Simultaneous radiotherapy treatment
  • Language barriers or communication difficulties
  • Problematic venous access
  • Known problems with administration of the therapy

Treatment and study plan

Oncological Home Hospitalization

Procedure

Primary outcomes

  1. 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)

    Time frame: 8 weeks

    Sensitivity will be analysed by comparing average outcome-scores between both groups

  2. 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)

    Time frame: 8 weeks

    Sensitivity will be analysed by comparing average outcome-scores between

  3. Sensitivity of the questionnaire HADS to measure anxiety and depression in patients being treated at different ambulatory care settings (hospital vs home)

    Time frame: 8 weeks

    Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups

  4. Sensitivity of the questionnaire Distress Barometer to measure distress in patients being treated at different ambulatory care settings (hospital vs home)

    Time frame: 8 weeks

    Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups

  5. Sensitivity of a self-designed questionnaire to measure the safety feeling of patients being treated at different ambulatory care settings (hospital vs home)

    Time frame: 8 weeks

    Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups

Secondary outcomes

  1. Costs inventory representing total costs for an ambulant treated cancer patient

    Time frame: 8 weeks

    Patients will be asked to record their medical consumptions during the first 8 weeks of treatment using a costs form. Furthermore, also hospital financial data wil be implemented in the costs inventory.

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2017
Registry last updated
Mar 30, 2018

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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