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Clinical Trials/NCT02844608
NCT02844608
Unknown
N/A

Quality of Life Assessment in Routine Clinical Oncology Practice at the University Hospital of Besancon

Centre Hospitalier Universitaire de Besancon1 site in 1 country152 target enrollmentMarch 10, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
152
Locations
1
Primary Endpoint
Rate of HRQOL questionnaire completion
Last Updated
8 years ago

Overview

Brief Summary

Symptoms related to the disease and/or treatment are common in cancer patients and can affect patient health-related quality of life (HRQol). Unfortunately these symptoms can be underestimated and underreported by the physician. Measure of the HRQoL has been significantly developed in clinical trials and has become a key endpoint to assess clinical benefit of new therapeutic strategies and as prognostic factor of overall survival for several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer, prostate cancer and hepatocellular carcinoma.

Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for advanced solid tumors showed that clinical benefits were associated with symptom self-reporting during cancer care, including the improvement of the overall survival.

The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to physician, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on the perception of the patients of their HRQoL and symptoms.

Detailed Description

The purpose of this study is to evaluate the feasibility of using in routinely clinical practice a systematic assessment of HRQoL in patients treated for a newly diagnosis cancer at the University Hospital of Besançon. It aims to define the logistic resources needed to implement this data collection and to assess its acceptability by clinicians, healthcare team and patients. This involves asking patients to complete HRQoL questionnaires at the time of an outpatient visit and generating a summary of the results made available to the healthcare provider immediately before the consultation. In this pilot study, three cancer sites were selected: breast cancer in women, colorectal cancer and lung cancer. Patients included will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the specific module of their cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) before each visit with their physician. Results from HRQoL questionnaires will be immediately available to physician through a web-based portal during the visit. As part of the pilot phase, patients will be followed during four months while HRQoL will be pursued. Questionnaires completion will be administrated by digital tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System; http:// www.ches.pro/) at the University Hospital of Besançon just before the visit with physician or at home via secured web-portal. This tool provides a didactic and attractive presentation of the HRQOL evaluation allowing physician a better understanding and consideration of HRQoL results. Indeed, results of a routinely assessment of HRQoL will be incorporated into the patient's electronic medical record. Physicians will be alerted if a clinically significant deterioration of at least one HRQoL dimension is observed over time and/or if the HRQoL level is significantly lower than reference/ normative data. In case of deterioration of HRQoL, physician may adapted the treatment or prescribed adapted supportive cares. This feasibility study aims to assess the acceptability of the HRQoL assessment in routinely practice: to quantify the attrition, to observe the exhaustiveness of the measure, the compliance and the ability of the patient to complete HRQoL questionnaires and finally to evaluate both patient and clinician's satisfaction. The difficulties eventually encountered by the clinical research associate and by physicians will be also collected.

Registry
clinicaltrials.gov
Start Date
March 10, 2016
End Date
March 10, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males and Females, ≥ 18 years of age
  • No prior diagnosis of cancer
  • Patients with newly diagnosed breast, colorectal or lung cancer
  • No prior therapy for cancer except surgery
  • Patients treated at University Hospital of Besançon
  • Patients had given their informed consent to participate.

Exclusion Criteria

  • Patients with tumor recurrence,
  • Patients with second cancer
  • Patients with psychopathology or serious cognitive problems

Outcomes

Primary Outcomes

Rate of HRQOL questionnaire completion

Time Frame: 1 year

Study Sites (1)

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