One-Page Truth-Telling Aid for Cancer Disclosure

NCT07730164 | Recruiting

• 1 other identifier: NSTC 114-2635-B-182-002 -
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplams; Physician-Patient Relations; Communication Research; Disclosure; Communication About Health Information; Preference, Patient

Keywords

Cancer truth-telling; disclosure preferences; physician-patient communication; communication aid; oncology care; psychooncology

Outcome Measures

Primary Outcomes (1)

• Patients' Truth-Telling Preferences and Perceptions

  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

Secondary Outcomes (8)

• 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

Study Arms (2)

One-Page Truth-Telling Aid

EXPERIMENTAL

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.

Behavioral: One-Page Truth-Telling Aid

Blank Sheet

ACTIVE COMPARATOR

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.

Behavioral: Blank Sheet

Interventions

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.

One-Page Truth-Telling Aid

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.

Blank Sheet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chang Gung University

Taoyuan, 33302, Taiwan

RECRUITING

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Shih-Ying Chen, PhD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Ying Chen, PhD

CONTACT

+886-32118800 #5212; s26871193@cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participating physicians will be assigned to the experimental or control group. Patients will be allocated according to the group assignment of their participating physician. The experimental group will use the One-Page Truth-Telling Aid, whereas the control group will receive usual care with a blank sheet for writing down questions.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 28, 2026
• Study Start: November 27, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)