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One-Page Truth-Telling Aid for Cancer Disclosure

2026年7月22日 更新者：Shih-Ying Chen、Chang Gung University

A One-Page Truth-Telling Aid for Cancer Disclosure in Taiwan: A Two-Arm Pragmatic Randomized Controlled Trial

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

400

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 台湾
      • Taoyuan、台湾、33302
        • 招聘中
        • Chang Gung University
        • 接触：
        • 首席研究员：
          • Shih-Ying Chen, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

【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.

  • Exclusion Criteria:

    • Physicians who are unable or unwilling to complete study procedures or follow-up assessments.

【Patients】

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：One-Page Truth-Telling Aid
Patients in this arm will receive the One-Page Truth-Telling Aid before the truth-telling consultation. The aid will be completed with the patient before the visit and summarizes the patient's disclosure preferences, communication needs, and questions for the physician. Patients will be encouraged to provide the aid to their participating physician at the beginning of the consultation so that the physician can quickly understand the patient's preferences and tailor communication accordingly.
行为的：One-Page Truth-Telling Aid
The One-Page Truth-Telling Aid is a brief communication aid completed with patients before the consultation. It summarizes patients' disclosure preferences, communication needs, and questions for the physician. Patients are encouraged to provide the aid to their participating physician at the beginning of the consultation to support patient-centered communication.
有源比较器：Blank Sheet
Patients in this arm will receive a blank sheet before the truth-telling consultation. The blank sheet may be used to write down questions or concerns the patient would like to discuss with the physician. It does not include structured questions about disclosure preferences or communication needs. Patients will receive usual care and may choose whether to provide the blank sheet to their participating physician during the consultation.
行为的：Blank Sheet
The blank sheet is provided to patients before the consultation and may be used to write down questions or concerns. It does not include structured questions about disclosure preferences or communication needs.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Patients' Truth-Telling Preferences and Perceptions
大体时间：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.
Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention

次要结果测量

结果测量
措施说明
大体时间
Patients' Psychological Distress
大体时间：Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention

Patients' psychological distress will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 includes three subscales: depression, anxiety, and stress. Each subscale score ranges from 0 to 42, with higher scores indicating greater symptom severity.

Patients' psychological distress will also be assessed using the Distress Thermometer (DT), a single-item distress screening tool. Scores range from 0 to 10, with higher scores indicating greater distress. A score of 4 or higher indicates clinically relevant distress.
Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention
Physicians' Confidence in Communication
大体时间：Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
Physicians' confidence in communication with patients with cancer and their families will be assessed using the 21-item Confidence in Communication with Patients questionnaire. Items are scored from 1 to 10, with higher scores indicating greater confidence.
Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
Patients' Decision Regret
大体时间：3 months post-intervention and 6 months post-intervention
Patients' regret regarding their treatment decisions will be assessed using the Decision Regret Scale (DRS). Scores range from 0 to 100, with higher scores indicating greater decisional regret. A score greater than 25 indicates moderate to high decisional regret.
3 months post-intervention and 6 months post-intervention
Treatment-Related Adverse Events
大体时间：3 months post-intervention and 6 months post-intervention
Treatment-related adverse events will be evaluated using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) based on electronic health record data. Events are graded from 1 to 5, with higher grades indicating more severe adverse events.
3 months post-intervention and 6 months post-intervention
Medical Expenditure
大体时间：6 months post-intervention
Medical expenditure will be estimated using National Health Insurance points recorded in the electronic health record system, based on the local conversion basis in Taiwan.
6 months post-intervention
Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid
大体时间：1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
Physicians' perceived usefulness of the One-Page Truth-Telling Aid will be assessed using a single-item rating scale from 0 to 10, with higher scores indicating greater perceived usefulness.
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
大体时间：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 will be assessed using a single-item rating scale from 0 to 10, with higher scores indicating greater willingness to recommend the 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
大体时间：Immediately after the truth-telling consultation
Patients' trust in the physician and satisfaction with the disclosure experience will be assessed using single-item rating scales from 0 to 10, with higher scores indicating greater trust and satisfaction.
Immediately after the truth-telling consultation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chang Gung University

合作者

Chang Gung Memorial Hospital

调查人员

  • 首席研究员：Shih-Ying Chen, PhD、Chang Gung University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月27日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月28日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NSTC 114-2635-B-182-002 -

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because the dataset contains sensitive clinical and communication-related information from patients with cancer and participating physicians. De-identified aggregate results may be reported in publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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