Colorectal CancerNCT06625008
Preoperative 3D Models and Shared Decision-making
A study testing 3D-printed model in people with Colorectal Cancer and Shared Decision Making, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Shared Decision Making, Anxiety
- What is being tested?
- 3D-printed model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 15 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be >18 years
- Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum
Who cannot join
- Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Impact of 3D-Printed Model on Shared Decision-Making and Anxiety in Patients Undergoing Surgery: the SEAD Pilot Randomized Trial
The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.
Read the detailed description
In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.
- Conditions
- Colorectal Cancer, Shared Decision Making, Anxiety, Informed Consent
- Being tested
- 3D-printed model
- Keywords
- Colorectal cancer, 3D Model, Shared Decision Making, Preoperative anxiety, Patient knowledge, Informed Consent
- Medical subject headings
- Colorectal Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed modelOther
The Department of Radiology at Vanderbilt University Medical Center will create a 3D-printed human torso model that includes the colon, rectum, and a stoma on the abdominal wall. This model will be used to provide pre-operative counseling during the surgical consent for patients.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed model arm | Experimental | Surgeons in this arm will use a 3D-printed modular human torso model with a magnetically detachable colon and rectum to teach patients about the anatomy and proximity of colonic segments undergoing surgery, potential surgical complications, and operative procedures during the pre-operative consent. Receives: Other: 3D-printed model |
| Standard care arm | No intervention | Surgeons will employ the usual pre-operative counseling in this arm. This will include teaching patients about the anatomy, operative procedures, and potential surgical complications during the pre-operative consent using 2D images. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared decision making
Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.
Measured: Within 30 minutes after the preoperative counselling session.
Secondary outcomes (2)
Change in patient anxiety
Quantify and compare patient anxiety levels before and after the pre-operative consent, measured by the validated State-Trait Anxiety Inventory (STAI-6) among the study arms.
Measured: Within 30 minutes before and 30 minutes after the preoperative counselling session.
Change in patient knowledge using a self-developed questionnaire
Using a self-developed questionnaire to quantify and compare patient knowledge of the essential aspects of anatomy, disease, and surgical procedure covered in preoperative counseling to understand how patient knowledge improves with counseling and compares between the study arms.
Measured: Within 30 minutes before and 30 minutes after the preoperative counselling session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Mar 2022
- Primary completion1 Jun 2023
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimal Khan, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625008
- Sponsor's protocol ID
- 211314
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan A, Sellyn GE, Ali D, Moazzam Z, Samaras H, McChesney SL, Hopkins MB, Ford MM, Muldoon RL, Geiger TM, Martin D, Chu DI, VanKoevering KK, Hawkins AT. Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513187. doi: 10.1001/jamanetworkopen.2025.13187.
PubMed 40459895
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 3D-Printed Model on Shared Decision-Making and Anxiety in Patients Undergoing Surgery: the SEAD Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT06625008
- Acronym / sponsor ID
- 211314
- Conditions
- Colorectal Cancer, Shared Decision Making, Anxiety, Informed Consent
- Keywords
- Colorectal cancer, 3D Model, Shared Decision Making, Preoperative anxiety, Patient knowledge, Informed Consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 3 Oct 2024 (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 objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.
Detailed description
In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed model arm | Experimental | Other: 3D-printed modelSurgeons in this arm will use a 3D-printed modular human torso model with a magnetically detachable colon and rectum to teach patients about the anatomy and proximity of colonic segments undergoing surgery, potential surgical complications, and operative procedures during the pre-operative consent. |
| Standard care arm | No intervention | –Surgeons will employ the usual pre-operative counseling in this arm. This will include teaching patients about the anatomy, operative procedures, and potential surgical complications during the pre-operative consent using 2D images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be >18 years
- Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum
Key exclusion criteria (1 listed)
- Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum
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 |
|---|---|---|
| 3D-printed modelThe Department of Radiology at Vanderbilt University Medical Center will create a 3D-printed human torso model that includes the colon, rectum, and a stoma on the abdominal wall. This model will be used to provide pre-operative counseling during the surgical consent for patients. | Other | 3D-printed model arm |
Primary outcome
Shared decision making
Time frame: Within 30 minutes after the preoperative counselling session.
Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.
2 secondary outcomes
Change in patient anxiety
Time frame: Within 30 minutes before and 30 minutes after the preoperative counselling session.
Change in patient knowledge using a self-developed questionnaire
Time frame: Within 30 minutes before and 30 minutes after the preoperative counselling session.
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 3 Oct 2024.
- Derived from this study: PubMed 40459895Khan A, Sellyn GE, Ali D, Moazzam Z, Samaras H, McChesney SL, Hopkins MB, Ford MM, Muldoon RL, Geiger TM, Martin D, Chu DI, VanKoevering KK, Hawkins AT. Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513187. doi: 10.1001/jamanetworkopen.2025.13187.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed model in people with Colorectal Cancer and Shared Decision Making, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 inclusion and 1 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 3 Oct 2024. 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 United States. 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 (time frame: Within 30 minutes after the preoperative counselling session.). 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 NCT06625008, which also lists 1 linked publication.
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 3 Oct 2024.