QOLIBRY: Feasibility of Quality of Life Assessment in Routine Clinical Oncology Practice at the University Hospital of Besancon
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Quality of Life Administration of Quality of Life questionnaires |
Other: Quality of Life Questionnaires
Patients will be asked to complete standardized HRQoL questionnaires: the EORTC QLQ-C30 with its specific module by cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) at first visit before starting treatment and then before every medical consultation during four months.
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Outcome Measures
Primary Outcome Measures
- Rate of HRQOL questionnaire completion [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and Females, ≥ 18 years of age
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No prior diagnosis of cancer
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Patients with newly diagnosed breast, colorectal or lung cancer
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No prior therapy for cancer except surgery
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Patients treated at University Hospital of Besançon
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Patients had given their informed consent to participate.
Exclusion Criteria:
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Patients with tumor recurrence,
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Patients with second cancer
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Patients with psychopathology or serious cognitive problems
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier régional Universitaire de Besançon | Besancon | France | 25000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21.
- Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4. Review.
- Velikova G, Awad N, Coles-Gale R, Wright EP, Brown JM, Selby PJ. The clinical value of quality of life assessment in oncology practice-a qualitative study of patient and physician views. Psychooncology. 2008 Jul;17(7):690-8.
- Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24.
- P/2015/274