One-Page Truth-Telling Aid for Cancer Disclosure

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.

• One-Page Truth-Telling Aid (Behavioral): 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.
• Blank Sheet (Behavioral): 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.

Primary outcomes

• Patients' Truth-Telling Preferences and Perceptions [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.

Secondary outcomes

• Patients' Psychological Distress [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.
• 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]: 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.
• Patients' Decision Regret [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.
• Treatment-Related Adverse Events [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.
• Medical Expenditure [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.
• 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' 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.
• 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]: 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.
• Patients' Trust in the Physician and Satisfaction With the Disclosure Experience [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.

Sex: All

【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.

• Shih-Ying Chen, PhD, Principal investigator, Chang Gung University