Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

One-Page Truth-Telling Aid for Cancer Disclosure

22. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Taiwan
      • Taoyuan, Taiwan, 33302
        • Rekruttering
        • Chang Gung University
        • Kontakt:
        • Ledende efterforsker:
          • Shih-Ying Chen, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

【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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients' Truth-Telling Preferences and Perceptions
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients' Psychological Distress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chang Gung University

Samarbejdspartnere

Chang Gung Memorial Hospital

Efterforskere

  • Ledende efterforsker: Shih-Ying Chen, PhD, Chang Gung University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. november 2025

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

22. juli 2026

Først opslået (Faktiske)

28. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NSTC 114-2635-B-182-002 -

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner