Anxiety, Colorectal Cancer, Informed Consent, Shared Decision Making
Conditions
Keywords
Colorectal cancer, 3D Model, Shared Decision Making, Preoperative anxiety, Patient knowledge, Informed Consent
Brief 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.
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.
Interventions
OTHER3D-printed model
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Masking was not performed as it was not feasible
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be \>18 years * Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum
Exclusion criteria
* Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared decision making | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient anxiety | Within 30 minutes before and 30 minutes after the preoperative counselling session. | 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. |
| Change in patient knowledge using a self-developed questionnaire | Within 30 minutes before and 30 minutes after the preoperative counselling session. | 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. |
Countries
United States
Outcome results
None listed