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临床试验/NCT02844608
NCT02844608Unknown不适用

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

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2016年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
152
试验地点
2
主要终点
Rate of HRQOL questionnaire completion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Quality of Life

Other

Administration of Quality of Life questionnaires

干预措施: Quality of Life Questionnaires (Other)

结局指标

主要结局

Rate of HRQOL questionnaire completion

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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