Lung Cancer PatientsNCT07062393
Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery
A study testing Traditional Counseling → MAR Counseling and MAR Counseling → Traditional Counseling in people with Lung Cancer Patients, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This randomized clinical trial evaluates the effectiveness of Mobile Augmented Reality (MAR) counseling compared to traditional verbal counseling for patients undergoing thoracic surgery. MAR counseling integrates patient-specific 3D anatomical models to enhance understanding of surgical procedures and risks. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lung Cancer Patients
- What is being tested?
- Traditional Counseling → MAR Counseling and MAR Counseling → Traditional Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2022to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years and older
- Scheduled for elective thoracic surgery
- Able to understand written and spoken Mandarin
- Willing and able to provide informed consent
- Capable of completing questionnaires independently or with minimal assistance
Who cannot join
- Emergency surgery cases
- Severe cognitive impairment or psychiatric illness interfering with participation
- Visual or hearing impairments that prevent interaction with mobile devices
- Previous participation in a similar counseling trial
- Inability to complete follow-up procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: A Randomized Clinical Controlled Trial
This randomized clinical trial evaluates the effectiveness of Mobile Augmented Reality (MAR) counseling compared to traditional verbal counseling for patients undergoing thoracic surgery. MAR counseling integrates patient-specific 3D anatomical models to enhance understanding of surgical procedures and risks. The study assesses patient and caregiver satisfaction, decision-making confidence, and communication quality. Health care providers' perspectives on the counseling methods are also examined. Participants will be assigned to one of the two counseling groups and asked to complete a questionnaire immediately after the counseling session.
- Conditions
- Lung Cancer Patients
- Being tested
- Traditional Counseling → MAR Counseling, MAR Counseling → Traditional Counseling
- Keywords
- Shared decision making, Patient education, Augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Counseling → MAR CounselingBehavioural
A single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images.
MAR Counseling → Traditional CounselingBehavioural
A single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images.
| Study group | Role | What they receive |
|---|---|---|
| Traditional First, Then MAR Counseling (T-M group) | Experimental | Participants receive traditional counseling first, followed by MAR counseling using a 3D mobile application. Receives: Behavioral: Traditional Counseling → MAR Counseling |
| MAR First, Then Traditional Counseling (M-T group) | Experimental | Participants receive MAR counseling first using a mobile 3D model app, followed by traditional counseling with CT images and verbal explanations. Receives: Behavioral: MAR Counseling → Traditional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared decision-making score
Shared decision-making was evaluated using a validated questionnaire assessing patient perceptions of decision support, preparedness, and engagement. The total score ranges from 0 to 50, with higher scores indicating better shared decision-making.
Measured: Immediately after counseling session (single timepoint)
Secondary outcomes (1)
Patient counseling preference
Participants indicated their preference for either traditional counseling or MAR-based counseling after experiencing both, using a structured post-intervention questionnaire. The results were reported as percentages per group.
Measured: Immediately after both counseling sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start15 Jul 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer PatientsStudies 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
- Crossover
- Model description
- This study employs a 2-period, 2-sequence crossover design in which all participants receive both interventions (traditional counseling and mobile augmented reality \[MAR\] counseling) in different sequences. Participants are randomly assigned to either the traditional-then-MAR group (T-M group) or the MAR-then-traditional group (M-T group). This design allows within-subject comparison of counseling effectiveness, minimizing individual variability.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Ying-Shian, Tri-Service General Hospital (TSGH)
- Investigators
- Kuan-Hsun Lin, MD, Principal investigator, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062393
- Sponsor's protocol ID
- TSGH-MAR-SDM-2025
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to ethical considerations and institutional policy. The informed consent obtained from participants does not include provisions for public data sharing.
Publications
McDonald M, Shirk JD. The Effect of Digital Three-Dimensional Reality Models on Patient Counseling for Renal Masses. JSLS. 2023 Jan-Mar;27(1):e2022.00084. doi: 10.4293/JSLS.2022.00084.
PubMed 36818764Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.
PubMed 34542639Deber RB, Kraetschmer N, Irvine J. What role do patients wish to play in treatment decision making? Arch Intern Med. 1996 Jul 8;156(13):1414-20.
PubMed 8678709Braddock CH 3rd, Fihn SD, Levinson W, Jonsen AR, Pearlman RA. How doctors and patients discuss routine clinical decisions. Informed decision making in the outpatient setting. J Gen Intern Med. 1997 Jun;12(6):339-45. doi: 10.1046/j.1525-1497.1997.00057.x.
PubMed 9192250Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
PubMed 12724430Lackey A, Donington JS. Surgical management of lung cancer. Semin Intervent Radiol. 2013 Jun;30(2):133-40. doi: 10.1055/s-0033-1342954.
PubMed 24436529Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Chen YS, Hsu YC, Romalee W, Wang DH, Lai J, Huang TW, Lin KH. Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: Randomized Clinical Crossover Trial. JMIR Mhealth Uhealth. 2025 Nov 13;13:e79632. doi: 10.2196/79632.
PubMed 41069141
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: A Randomized Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT07062393
- Acronym / sponsor ID
- TSGH-MAR-SDM-2025
- Conditions
- Lung Cancer Patients
- Keywords
- Shared decision making, Patient education, Augmented reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 14 Jul 2025 (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.
This randomized clinical trial evaluates the effectiveness of Mobile Augmented Reality (MAR) counseling compared to traditional verbal counseling for patients undergoing thoracic surgery. MAR counseling integrates patient-specific 3D anatomical models to enhance understanding of surgical procedures and risks. The study assesses patient and caregiver satisfaction, decision-making confidence, and communication quality. Health care providers' perspectives on the counseling methods are also examined. Participants will be assigned to one of the two counseling groups and asked to complete a questionnaire immediately after the counseling session.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a 2-period, 2-sequence crossover design in which all participants receive both interventions (traditional counseling and mobile augmented reality [MAR] counseling) in different sequences. Participants are randomly assigned to either the traditional-then-MAR group (T-M group) or the MAR-then-traditional group (M-T group). This design allows within-subject comparison of counseling effectiveness, minimizing individual variability.
| Arm | Type | Receives |
|---|---|---|
| Traditional First, Then MAR Counseling (T-M group) | Experimental | Behavioral: Traditional Counseling → MAR CounselingParticipants receive traditional counseling first, followed by MAR counseling using a 3D mobile application. |
| MAR First, Then Traditional Counseling (M-T group) | Experimental | Behavioral: MAR Counseling → Traditional CounselingParticipants receive MAR counseling first using a mobile 3D model app, followed by traditional counseling with CT images and verbal explanations. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 20 years and older
- Scheduled for elective thoracic surgery
- Able to understand written and spoken Mandarin
- Willing and able to provide informed consent
- Capable of completing questionnaires independently or with minimal assistance
Key exclusion criteria (5 listed)
- Emergency surgery cases
- Severe cognitive impairment or psychiatric illness interfering with participation
- Visual or hearing impairments that prevent interaction with mobile devices
- Previous participation in a similar counseling trial
- Inability to complete follow-up procedures
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 |
|---|---|---|
| Traditional Counseling → MAR CounselingA single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images. | Behavioural | Traditional First, Then MAR Counseling (T-M group) |
| MAR Counseling → Traditional CounselingA single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images. | Behavioural | MAR First, Then Traditional Counseling (M-T group) |
Primary outcome
Shared decision-making score
Time frame: Immediately after counseling session (single timepoint)
Shared decision-making was evaluated using a validated questionnaire assessing patient perceptions of decision support, preparedness, and engagement. The total score ranges from 0 to 50, with higher scores indicating better shared decision-making.
1 secondary outcome
Patient counseling preference
Time frame: Immediately after both counseling sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 36818764McDonald M, Shirk JD. The Effect of Digital Three-Dimensional Reality Models on Patient Counseling for Renal Masses. JSLS. 2023 Jan-Mar;27(1):e2022.00084. doi: 10.4293/JSLS.2022.00084.
- Background: PubMed 34542639Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.
- Background: PubMed 8678709Deber RB, Kraetschmer N, Irvine J. What role do patients wish to play in treatment decision making? Arch Intern Med. 1996 Jul 8;156(13):1414-20.
- Background: PubMed 9192250Braddock CH 3rd, Fihn SD, Levinson W, Jonsen AR, Pearlman RA. How doctors and patients discuss routine clinical decisions. Informed decision making in the outpatient setting. J Gen Intern Med. 1997 Jun;12(6):339-45. doi: 10.1046/j.1525-1497.1997.00057.x.
- Background: PubMed 12724430Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
- Background: PubMed 24436529Lackey A, Donington JS. Surgical management of lung cancer. Semin Intervent Radiol. 2013 Jun;30(2):133-40. doi: 10.1055/s-0033-1342954.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Derived from this study: PubMed 41069141Chen YS, Hsu YC, Romalee W, Wang DH, Lai J, Huang TW, Lin KH. Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: Randomized Clinical Crossover Trial. JMIR Mhealth Uhealth. 2025 Nov 13;13:e79632. doi: 10.2196/79632.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to ethical considerations and institutional policy. The informed consent obtained from participants does not include provisions for public data sharing.
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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. This study is not recruiting at the moment.
Kuan-Hsun Lin, MD principal investigator
Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Counseling → MAR Counseling and MAR Counseling → Traditional Counseling in people with Lung Cancer Patients, run by Tri-Service General Hospital (TSGH) 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 5 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: finished, as of the sponsor's last update on 17 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared decision-making score (time frame: Immediately after counseling session (single timepoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07062393, which also lists 8 linked publications.
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 17 Jul 2025.