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One-Page Truth-Telling Aid for Cancer Disclosure

22 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

400

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Taïwan
      • Taoyuan, Taïwan, 33302
        • Recrutement
        • Chang Gung University
        • Contact:
        • Chercheur principal:
          • Shih-Ying Chen, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

【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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Comparateur actif: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patients' Truth-Telling Preferences and Perceptions
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patients' Psychological Distress
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chang Gung University

Collaborateurs

Chang Gung Memorial Hospital

Les enquêteurs

  • Chercheur principal: Shih-Ying Chen, PhD, Chang Gung University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 novembre 2025

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 juillet 2027

Dates d'inscription aux études

Première soumission

21 juillet 2026

Première soumission répondant aux critères de contrôle qualité

22 juillet 2026

Première publication (Réel)

28 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NSTC 114-2635-B-182-002 -

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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