One-Page Truth-Telling Aid for Cancer Disclosure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Patients' Truth-Telling Preferences and Perceptions [Срок оценки: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention]

Вторичные конечные точки (8)

• Patients' Psychological Distress [Срок оценки: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention]
• Physicians' Confidence in Communication [Срок оценки: Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention]
• Patients' Decision Regret [Срок оценки: 3 months post-intervention and 6 months post-intervention]
• Treatment-Related Adverse Events [Срок оценки: 3 months post-intervention and 6 months post-intervention]
• Medical Expenditure [Срок оценки: 6 months post-intervention]
• Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Immediately after the truth-telling consultation]

Критерии участия

【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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• Chang Gung University — Taoyuan

Идентификаторы

NCT: NCT07730164 · NSTC 114-2635-B-182-002 -

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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