Impact of Routine Electronic Monitoring of Health-related Quality of Life on Care Relationship of Cancer Patients With Non-small Cell Lung Cancer, Locally Advanced or Metastatic, Systemic Treatment-naïve: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- quality of care relationship, assessed for patients and physicians: AREP questionnaire
研究概览
简要总结
Routine electronic monitoring of health-related quality of life (REMOQOL) consists of collecting HRQoL patients' data via an electronic device in order to provide these data to healthcare providers. Collected data could be used by professionals to personalize care through for instance, orientation towards personalized supportive care; assessment of toxicities related to treatments or adapted treatments.
The aim of this study is to investigate the impact of REMOQOL on the care relationship in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are naïve for systemic treatment. To do this, the investigators want to conduct a randomized trial at the Besançon University Hospital.
Several teams are collaborating on this project: Methodology and Quality of Life Unit in Oncology (UMQVC), pneumonology and medical oncology services of the Besançon University Hospital and psychology laboratories of Franche-Comté and Burgundy Universities.
The original aspects of this research are the particular interest in the care relationship between physicians and patients, also taking an interest in the physician's experience, the strong collaboration with researchers in psychology, the use of mixed quantitative and qualitative analysis techniques as well as the design of randomized study.
详细描述
REMOQOL-Poumon is an interventional, prospective, randomized study, conducted in Besançon University Hospital. Patients are randomized whether in the experimental arm or in the control arm. Intervention in experimental arm consists of administration of HRQoL questionnaires (QLQ-C30 & QLQ-LC13) using the CHES software (Computer-based Health Evaluation System) and presentation of the HRQoL scores to physicians via colored graphics.
In control arm, HRQoL questionnaires (QLQ-C30+LC13) are administered in a paper-pencil way, without transmission of results to physicians.
Patients are followed for four encounters with HRQoL collection. The primary outcome, measured with the AREP questionnaire, is assessed after those four encounters.
At the end of the follow-up, a semi-structured interview with a researcher in psychology and concerning the care relationship is proposed to a sub-cohort of patients (around ten patients in each arm).
After each encounter, physicians are asked to answer a questionnaire on viewing and use of HRQoL scores. Every physician will be interviewed on care relationship by a researcher in psychology.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with tumor recurrence
- •Patients receiving oral antineoplastic therapy for whom at least monthly follow-up is not feasible
- •Patients with psychopathology or serious cognitive problems
结局指标
主要结局
quality of care relationship, assessed for patients and physicians: AREP questionnaire
时间窗: Month 3
care relationship assessed with the AREP questionnaire. AREP is for "adjustment relationnel expérimenté perçu", which means experienced and perceived relational adjustment.
次要结局
- Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores(Month 3)
- Quality of care relationship, assessed for patients and physicians: semi-structured interviews(Month 24)
- Acceptability of HRQoL collection(Month 24)
- Progression-free survival(Year 5)
- Overall survival(Year 5)
- Preferences and expectations in the care relationship, assessed for patients and physicians(Day 1)
- intention of use of REMOQOL(Month 24)