ComCancer - Integration Into the Radiation Oncology Care Trajectory of the Let's Discuss Health Website and Evaluation of Its Effects in Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Dialogic rate in the exchanges during the initial patient-radiation oncologist encounter
研究概览
简要总结
In Canada, the prevalence of cancer is growing and contributes significantly to health costs. The prevention and treatment of cancer is a major concern of our health system. Many men with prostate cancer develop psychological distress. The emotional consequences of a cancer diagnosis and its treatments can prevent patients from communicating effectively with their healthcare team. It is recognized that the quality of communication between cancer patients and their caregivers plays an important role in the management of their disease. However, few tools are being developed to help clinicians and patients better communicate and decrease patients' psychological distress. Let's Discuss Health (www.discutonssante.ca) is a French-language website that offers several tools to support collaboration between caregivers and cancer patients.
The objectives of this research project are to assess the experience of using the Let's Discuss Health website and the impact of its use on the quality of communication between radiation oncologists and patients, the level of distress of patients with prostate cancer, recall of the information discussed as well as adherence to the trajectory in radiation oncology.
The project will take place in three radiation oncology centers in Quebec. Two groups of prostate cancer patients will be recruited. Patients in the first group will be assessed on the basis of regular consultations and those in the second group will be encouraged to prepare for their medical visits using the Let's Discuss Health website. Patients and their caregivers will answer short questionnaires before and after four targeted consultations (initial visit, mid-treatment visit, end-of-treatment visit and 3-month post-treatment visit). Focus groups will also be organized to explore the impact of the website.
This project offers the potential to transform clinical practices in radiation oncology to reduce the burden of cancer and improve the quality of care offered to patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •have a diagnosis of prostate cancer
- •understand, speak and read French
- •report being comfortable using the Internet
- •have access to a computer, tablet or smartphone or know someone who does and is willing to accompany them
排除标准
- •being considered unfit to give free and informed consent (e.g. dementia, severe psychiatric condition)
- •any other clinical reason (poor health of the patient at the time of the consultation) that the clinician deems relevant
结局指标
主要结局
Dialogic rate in the exchanges during the initial patient-radiation oncologist encounter
时间窗: Baseline (0 week)
Using Medicode, the exchanges during the medical encounters will be qualified as dialogue or monologue for each of the topics covered in the discussion of cancer itself and each of the treatment options discussed according to the following themes: designation, dosage, main effect observed, main effect anticipated, side effects observed, possible side effects, indication to consult again, attitudes and emotions and warnings. The dialogic rate (DR) will be generated. It is determined by the proportion of exchanges on a topic that is a dialogue, i.e., a contribution to the content exchanged by each of the interlocutors, and the proportion that is a monologue, i.e., a contribution to the content by a single interlocutor. The DR score ranged between 0 (monologue) and 1 (dialogue). An overall DR score per targeted treatment option will be calculated by aggregating the scores for each of the topics discussed in relation to that treatment.
Patient use of Let's Discuss Health tools
时间窗: Through study completion, an average of 8 months
Proportion of patients in the Intervention Group who complete the Let's Discuss Health summary sheet at each of the four targeted visits.
Dialogic rate of the conversations during the end-of-treatment patient-radiation oncologist encounter
时间窗: Up to 5 months
Using Medicode, the exchanges during the medical encounters will be qualified as dialogue or monologue for each of the topics covered in the discussion of cancer itself and each of the treatment options discussed according to the following themes: designation, dosage, main effect observed, main effect anticipated, side effects observed, possible side effects, indication to consult again, attitudes and emotions and warnings. The dialogic rate (DR) will be generated. It is determined by the proportion of exchanges on a topic that is a dialogue, i.e., a contribution to the content exchanged by each of the interlocutors, and the proportion that is a monologue, i.e., a contribution to the content by a single interlocutor. The DR score ranged between 0 (monologue) and 1 (dialogue). An overall DR score per targeted treatment option will be calculated by aggregating the scores for each of the topics discussed in relation to that treatment.
Pre-consultation patient emotional distress during the care trajectory
时间窗: Through study completion, an average of 8 months
The psychological distress before the medical encounters throughout the care trajectory will be assessed using the distress thermometer developed by the National Comprehensive Cancer Network. The level of emotional distress will be self-rated using a visual analog scale from 0 \[no distress\] to 10 \[extreme distress\].
Patient recall of information after the initial encounter
时间窗: Baseline (0 week)
Appropriate patient recall of the information discussed during the medical encounter will be assessed using a home-made questionnaire. Dimensions assessed include severity of the disease, treatment options, side effects, and perceived risk of the disease itself or its treatment. The questionnaire asks patients to indicate whether an information was discussed using a 3-point rating scale (yes, no, I don't remember). For each "yes" answer, patients are asked to provide the information discussed. The answers will be compared to the information coded using MEDICODE. Percentage of correct answers will be reported.
Patient recall of information after the end-of-treatment encounter
时间窗: Up to 5 months
Appropriate patient recall of the information discussed during the medical encounter will be assessed using a home-made questionnaire. Dimensions assessed include side effects and their management, when being cured, chances of survival following the treatment, probability of cancer recurrence, and follow-up. The questionnaire asks patients to indicate whether an information was discussed using a 3-point rating scale (yes, no, I don't remember). For each "yes" answer, patients are asked to provide the information discussed. The answers will be compared to the information coded using MEDICODE. Percentage of correct answers will be reported.
Adherence to the care pathway
时间窗: Through care pathway completion, an average of 5 weeks
Measurements of: 1) total number of treatments received compared to what was planned; 2) documented absences from scheduled appointments and reasons; 3) treatment delays and reasons if documented. Data will be extracted from the participant's medical chart and follow-up notes of the nurse.
次要结局
- Change in emotional distress following the medical encounter(Through study completion, an average of 8 months)
- Patient perception of the quality of the communication with the radiation oncologist(Through study completion, an average of 8 months)
- Radiation oncologist's perception of the quality of the consultation(Through study completion, an average of 8 months)
- Patient appreciation of the use of the Let's Discuss Health website(Through study completion, an average of 8 months)
- Frequency of themes discussed during the end-of-treatment patient-radiation oncologist encounter(Up to 5 months)
- Preponderance of initiative in the discussion during the end-of-treatment patient-radiation oncologist encounter(Up to 5 months)
- Radiation oncologist appreciation of Let's Discuss Health implementation in clinical routines in radiation oncology(At the end of the study, up to 1.5 years)
- Frequency of themes discussed during the initial patient-radiation oncologist encounter(Baseline (0 week))
- Preponderance of initiative in the discussion during the initial patient-radiation oncologist encounter(Baseline (0 week))
- Qualitative patient appreciation of the use of Let's Discuss Health(At the end of the study, up to 1.5 years)
- Number of problems related to the cancer during the care trajectory(Through study completion, an average of 8 months)
- Intensity of symptoms during the care trajectory(Through study completion, an average of 8 months)