One-Page Truth-Telling Aid for Cancer Disclosure
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Shih-Ying Chen, PhD
- 電話番号：+886-32118800 #5212
- メール：s26871193@cgu.edu.tw
研究場所
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-
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Taoyuan、台湾、33302
- 募集
- Chang Gung University
-
コンタクト：
- Shih-Ying Chen, PhD
- 電話番号：+886-32118800 #5212
- メール：s26871193@cgu.edu.tw
-
主任研究者：
- Shih-Ying Chen, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
【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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patients' Truth-Telling Preferences and Perceptions
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patients' Psychological Distress
時間枠：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
|
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Physicians' Confidence in Communication
時間枠：Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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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.
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Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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Patients' Decision Regret
時間枠：3 months post-intervention and 6 months post-intervention
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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.
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3 months post-intervention and 6 months post-intervention
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Treatment-Related Adverse Events
時間枠：3 months post-intervention and 6 months post-intervention
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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.
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3 months post-intervention and 6 months post-intervention
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Medical Expenditure
時間枠：6 months post-intervention
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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.
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6 months post-intervention
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Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid
時間枠：1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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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.
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1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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Physicians' Willingness to Recommend the One-Page Truth-Telling Aid
時間枠：1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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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.
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1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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Patients' Trust in the Physician and Satisfaction With the Disclosure Experience
時間枠：Immediately after the truth-telling consultation
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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.
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Immediately after the truth-telling consultation
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Shih-Ying Chen, PhD、Chang Gung University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NSTC 114-2635-B-182-002 -
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IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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