One-Page Truth-Telling Aid for Cancer Disclosure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChang Gung University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: One-Page Truth-Telling AidExperimental treatment 1 intervention
Group B: Blank SheetActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention

Secondary outcomes

1

Patients' Psychological Distress

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.

Time frame
Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention
2

Physicians' Confidence in Communication

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.

Time frame
Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
3

Patients' Decision Regret

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.

Time frame
3 months post-intervention and 6 months post-intervention
4

Treatment-Related Adverse Events

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.

Time frame
3 months post-intervention and 6 months post-intervention

Other outcomes

Sponsors and contacts

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Chang Gung University

Lead sponsor

Chang Gung Memorial Hospital

Collaborator