A One-Page Truth-Telling Aid for Cancer Disclosure in Taiwan: A Two-Arm Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Patients' Truth-Telling Preferences and Perceptions
研究概览
简要总结
The goal of this clinical trial is to learn whether a one-page communication aid can improve communication between physicians and patients with cancer during cancer-related truth-telling consultations. The one-page aid is designed to help physicians quickly understand patients' preferences and needs before the consultation.
The main questions it aims to answer are:
- Does the one-page communication aid improve patients' satisfaction with how cancer-related information is explained?
- Does the one-page communication aid reduce patients' emotional distress after the consultation?
- Does the one-page communication aid improve physicians' confidence in communicating cancer-related information?
Researchers will compare patients whose physicians receive the one-page communication aid with patients whose physicians provide usual care with a blank sheet for patients to write down questions. This comparison will help determine whether the one-page aid improves communication, emotional outcomes, and physician confidence.
Participants will:
- Complete questionnaires before and after the consultation
- Receive either the one-page communication aid or a blank sheet, depending on their physician's group
- Complete follow-up questionnaires at 3 months and 6 months after the consultation
Physicians will also complete brief questionnaires about their communication confidence at baseline, 1 week after recruitment of their first enrolled patient, 3 months, and 6 months.
详细描述
Cancer-related truth-telling is an important but challenging part of oncology care. Patients may differ in how much information they want to receive, how they prefer information to be explained, who they want to be present during the discussion, and what questions or concerns they wish to raise. In routine outpatient settings, physicians often have limited time to identify these individual preferences before discussing cancer-related information.
This study will evaluate a One-Page Truth-Telling Aid designed to help physicians quickly understand patients' disclosure preferences and communication needs before the consultation. The aid is completed with patients before the visit and summarizes key information for the physician, including the patient's preferred way of receiving information, preferred communication style, desired content, and questions the patient would like to ask.
This is a two-arm, single-blind, pragmatic clinical trial. Participating physicians will be assigned to either the experimental group or the control group. Patients will be allocated according to the group assignment of their participating physician. Patients in the experimental group will complete the One-Page Truth-Telling Aid before the consultation and will be encouraged to provide it to their physician at the beginning of the visit. Patients in the control group will receive a blank sheet that they may use to write down questions before the consultation.
The study will assess patient-reported truth-telling experiences, emotional distress, and decisional regret, as well as physician-reported communication confidence. Patient assessments will be conducted before the consultation, immediately after the consultation, and at 3 and 6 months after the consultation. Physician assessments will be conducted before the intervention, 1 week after recruitment of their first enrolled patient, and at 3 and 6 months thereafter.
The study is expected to provide evidence on whether a brief, low-burden communication aid can support patient-centered truth-telling in oncology outpatient care and improve communication-related outcomes for both patients and physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Patients will be masked to group assignment. Both groups will receive a study sheet before the consultation to support preparation for the visit. Patients in the experimental group will receive the One-Page Truth-Telling Aid, whereas patients in the control group will receive a blank sheet.
Physicians and the research assistant cannot be masked because they are involved in delivering information or using the assigned study materials and data collection.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •【Physicians】
- •Inclusion Criteria:
- •Physicians who provide clinical care for patients with cancer in participating outpatient departments.
- •Physicians who are involved in cancer-related truth-telling or disclosure consultations.
- •Physicians who are willing to participate and provide informed consent.
排除标准
- •Physicians who are unable or unwilling to complete study procedures or follow-up assessments.
- •Inclusion Criteria:
- •Patients diagnosed with cancer.
- •Patients who are scheduled to receive cancer-related information from a participating physician, including information about diagnosis, recurrence, metastasis, end-of-life status.
- •Patients who are able to communicate in Mandarin Chinese or Taiwanese.
- •Patients who are able to complete questionnaires independently or with assistance from the research assistant.
- •Patients who are willing to participate and provide informed consent.
- •Exclusion Criteria:
- •Patients who are unable to provide informed consent.
- •Patients with severe cognitive impairment, severe physical illness, or emotional distress that prevents participation, as judged by the clinical team or research staff.
- •Patients who are unable to complete the study questionnaires even with assistance.
结局指标
主要结局
Patients' Truth-Telling Preferences and Perceptions
时间窗: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention
Patients' truth-telling preferences and perceptions of physicians' actual disclosure practices will be assessed using the 43-item Truth-Telling Questionnaire (TTQ-43). The TTQ-43 includes four domains: how to deliver bad news, emotional support, additional information, and setting. Items are scored from 1 to 5, with higher scores indicating stronger preferences expectation at baseline or greater perceived alignment with physician practice at follow-up.
次要结局
- Patients' Psychological Distress(Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention)
- Physicians' Confidence in Communication(Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention)
- Patients' Decision Regret(3 months post-intervention and 6 months post-intervention)
- Treatment-Related Adverse Events(3 months post-intervention and 6 months post-intervention)
- Medical Expenditure(6 months post-intervention)
- Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid(1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention)
- Physicians' Willingness to Recommend the One-Page Truth-Telling Aid(1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention)
- Patients' Trust in the Physician and Satisfaction With the Disclosure Experience(Immediately after the truth-telling consultation)
研究者
Shih-Ying Chen
Assistant Professor
Chang Gung University