NeoplamsNCT07730164
One-Page Truth-Telling Aid for Cancer Disclosure
A study testing One-Page Truth-Telling Aid and Blank Sheet in people with Neoplams and Physician-Patient Relations, run by Chang Gung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplams, Physician-Patient Relations, Communication Research
- What is being tested?
- One-Page Truth-Telling Aid and Blank Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Physicians who are unable or unwilling to complete study procedures or follow-up assessments.
- 【Patients】
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 33302
Shih-Ying Chen, PhD, +886-32118800 #5212, s26871193@cgu.edu.tw
Shih-Ying Chen, PhD
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Neoplams, Physician-Patient Relations, Communication Research, Disclosure, Communication About Health Information, Preference, Patient
- Being tested
- One-Page Truth-Telling Aid, Blank Sheet
- Keywords
- Cancer truth-telling; disclosure preferences; physician-patient communication; communication aid; oncology care; psychooncology
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Page Truth-Telling AidBehavioural
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 SheetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| One-Page Truth-Telling Aid | Experimental | 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. Receives: Behavioral: One-Page Truth-Telling Aid |
| Blank Sheet | Active comparator | 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. Receives: Behavioral: Blank Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention
Secondary outcomes (8)
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.
Measured: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention
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.
Measured: Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
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.
Measured: 3 months post-intervention and 6 months post-intervention
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.
Measured: 3 months post-intervention and 6 months post-intervention
Medical Expenditure
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.
Measured: 6 months post-intervention
Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid
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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediately after the truth-telling consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start27 Nov 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplamsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating physicians will be assigned to the experimental or control group. Patients will be allocated according to the group assignment of their participating physician. The experimental group will use the One-Page Truth-Telling Aid, whereas the control group will receive usual care with a blank sheet for writing down questions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Shih-Ying Chen, Chang Gung University
- Investigators
- Shih-Ying Chen, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730164
- Sponsor's protocol ID
- NSTC 114-2635-B-182-002 -
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-Page Truth-Telling Aid for Cancer Disclosure in Taiwan: A Two-Arm Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07730164
- Acronym / sponsor ID
- NSTC 114-2635-B-182-002 -
- Conditions
- Neoplams, Physician-Patient Relations, Communication Research, Disclosure, Communication About Health Information, Preference, Patient
- Keywords
- Cancer truth-telling; disclosure preferences; physician-patient communication; communication aid; oncology care; psychooncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participating physicians will be assigned to the experimental or control group. Patients will be allocated according to the group assignment of their participating physician. The experimental group will use the One-Page Truth-Telling Aid, whereas the control group will receive usual care with a blank sheet for writing down questions.
| Arm | Type | Receives |
|---|---|---|
| One-Page Truth-Telling Aid | Experimental | Behavioral: One-Page Truth-Telling AidPatients 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. |
| Blank Sheet | Active comparator | Behavioral: Blank SheetPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (5 listed)
- 【Patients】
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-Page Truth-Telling AidThe 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. | Behavioural | One-Page Truth-Telling Aid |
| Blank SheetThe 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. | Behavioural | Blank Sheet |
Primary outcome
Patients' Truth-Telling Preferences and Perceptions
Time frame: 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.
8 secondary outcomes
Patients' Psychological Distress
Time frame: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention
Physicians' Confidence in Communication
Time frame: Baseline, 1 week after recruitment of the physician's first enrolled patient, 3 months post-intervention, and 6 months post-intervention
Patients' Decision Regret
Time frame: 3 months post-intervention and 6 months post-intervention
Treatment-Related Adverse Events
Time frame: 3 months post-intervention and 6 months post-intervention
Medical Expenditure
Time frame: 6 months post-intervention
Physicians' Perceived Usefulness of the One-Page Truth-Telling Aid
Time frame: 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
Time frame: 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
Time frame: Immediately after the truth-telling consultation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Neoplams
RecruitingPhase 2
A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)
Malignant Neoplam, Advanced Solid Tumors
Active, not recruitingObservational study
ProsBiT: Turkish Prostate Biopsy Study
Prostate Cancer (Adenocarcinoma), Prostatic Neoplams
Recruiting
Effect of Pecha Kucha-Based Education on Symptom Management and Quality of Life in Patients Receiving Chemotherapy
Cancer, Neoplams
RecruitingPhase 1
Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
Neoplams
RecruitingObservational study
Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
Prostatic Cancer, Prostatic Neoplams
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shih-Ying Chen, PhD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Page Truth-Telling Aid and Blank Sheet in people with Neoplams and Physician-Patient Relations, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Ying Chen, PhD (+886-32118800 #5212, s26871193@cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Truth-Telling Preferences and Perceptions (time frame: Baseline, immediately after the truth-telling consultation, 3 months post-intervention, and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.