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NCT Number: NCT07730164

One-Page Truth-Telling Aid for Cancer Disclosure

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, 33302, Taiwan

Location status: Recruiting

Location contact

Shih-Ying Chen, PhD

CONTACT

[email protected]

+886-32118800 #5212

Shih-Ying Chen, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

【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.

Treatment and study plan

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

  1. Patients' Truth-Telling Preferences and Perceptions

    Time frame: 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

  1. Patients' Psychological Distress

    Time frame: 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.

  2. Physicians' Confidence in Communication

    Time frame: 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.

  3. Patients' Decision Regret

    Time frame: 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.

  4. Treatment-Related Adverse Events

    Time frame: 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.

  5. Medical Expenditure

    Time frame: 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. Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid

    Time frame: 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.

  7. Physicians' Willingness to Recommend the One-Page Truth-Telling Aid

    Time frame: 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.

  8. Patients' Trust in the Physician and Satisfaction With the Disclosure Experience

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shih-Ying Chen, PhD

CONTACT

[email protected]

+886-32118800 #5212

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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