Shared Decision MakingPhase 2NCT05776381
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp
A Phase 2 study testing Shared Decision Making using a Patient Decision Aid. in people with Shared Decision Making and Colonic Polyp, run by Vejle Hospital.
Trial summary
Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shared Decision Making, Colonic Polyp, Decision Aids
- What is being tested?
- Shared Decision Making using a Patient Decision Aid.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2028to 1 Feb 2033
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.
Who cannot join
- Inability to provide informed consent
- Inoperable due to comorbidity
- Known residual tumor left in situ after local resection, >N0 or >M0
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study
Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.
Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.
This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.
- Conditions
- Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp, Colorectal Polyp, Colorectal Cancer
- Being tested
- Shared Decision Making using a Patient Decision Aid.
- Keywords
- non-randomized trial, malignant colorectal polyp, Patient Decision aid, Shared Decision Making
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making using a Patient Decision Aid.Other
The intervention comprises the surgeon actively using the tailored PtDA and SDM with the patient when deciding on the management of an unexpected malignant colorectal polyp.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making (SDM) | Experimental | Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care. Receives: Other: Shared Decision Making using a Patient Decision Aid. |
| Historical data arm | No intervention | Historical data on the management of patients with an unexpected malignant colorectal polyp from February 2018 to the end of 2022 retrieved through the Danish Colorectal Cancer Group Database, the National Pathology database and the National Patient Register. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
Measured: 30 days
Secondary outcomes (10)
Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.
Measured: 45 days
Number of patients with postoperative morbidity 30 days after surgery
Measured: 30 days postoperatively
Number of patients with postoperative mortality 30 days after surgery
Measured: 30 days postoperatively
Number of patients with postoperative morbidity 90 days after surgery
Measured: 90 days postoperatively
Number of patients with postoperative mortality 90 days after surgery
Measured: 90 days postoperatively
Number of patients with recurrence 3 years after cancer diagnosis
Measured: 3 years
Overall survival 3 years after cancer diagnosis
Measured: 3 years
Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
Score range 1-100. The higher the score, the better the quality of life.
Measured: 24 hours after clinical encounter
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
Score range 1-100. The higher the score, the better the quality of life.
Measured: 3 months after clinical encounter
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
Score range 1-100. The higher the score, the better the quality of life.
Measured: 6 months after clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Feb 2028 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Feb 2033 (estimated)
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 Shared Decision MakingStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study is a clinical multicenter, non-randomized, interventional phase II study. Three to five departments of colorectal surgery in Danish hospitals will be invited to participate in the study.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Würtz, MD, Principal investigator, Vejle Hospital, Center for Shared Decision Making and Surgical DepartmentKarina D Steffensen, Prof PhD MD, Study chair, Center For Shared Decision Making, Vejle HospitalHans B Rahr, Prof Dr MD, Study chair, Surgical Department, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776381
- Sponsor's protocol ID
- SDM in malignant polyps
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wurtz HJ, Rahr HB, Lindebjerg J, Edwards A, Steffensen KD. Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study. BMJ Open. 2023 Nov 14;13(11):e073900. doi: 10.1136/bmjopen-2023-073900.
PubMed 37963688
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study
- ClinicalTrials.gov ID
- NCT05776381
- Acronym / sponsor ID
- SDM in malignant polyps
- Conditions
- Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp, Colorectal Polyp, Colorectal Cancer
- Keywords
- non-randomized trial, malignant colorectal polyp, Patient Decision aid, Shared Decision Making
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 1 Feb 2028 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 20 Mar 2023 (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.
Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.
Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.
This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a clinical multicenter, non-randomized, interventional phase II study. Three to five departments of colorectal surgery in Danish hospitals will be invited to participate in the study.
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making (SDM) | Experimental | Other: Shared Decision Making using a Patient Decision Aid.Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care. |
| Historical data arm | No intervention | –Historical data on the management of patients with an unexpected malignant colorectal polyp from February 2018 to the end of 2022 retrieved through the Danish Colorectal Cancer Group Database, the National Pathology database and the National Patient Register. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Inoperable due to comorbidity
- Known residual tumor left in situ after local resection, >N0 or >M0
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 |
|---|---|---|
| Shared Decision Making using a Patient Decision Aid.The intervention comprises the surgeon actively using the tailored PtDA and SDM with the patient when deciding on the management of an unexpected malignant colorectal polyp. | Other | Shared Decision Making (SDM) |
Primary outcome
Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
Time frame: 30 days
10 secondary outcomes
Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.
Time frame: 45 days
Number of patients with postoperative morbidity 30 days after surgery
Time frame: 30 days postoperatively
Number of patients with postoperative mortality 30 days after surgery
Time frame: 30 days postoperatively
Number of patients with postoperative morbidity 90 days after surgery
Time frame: 90 days postoperatively
Number of patients with postoperative mortality 90 days after surgery
Time frame: 90 days postoperatively
Number of patients with recurrence 3 years after cancer diagnosis
Time frame: 3 years
Overall survival 3 years after cancer diagnosis
Time frame: 3 years
Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
Time frame: 24 hours after clinical encounter
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
Time frame: 3 months after clinical encounter
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
Time frame: 6 months after clinical encounter
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 30 Apr 2026.
- Derived from this study: PubMed 37963688Wurtz HJ, Rahr HB, Lindebjerg J, Edwards A, Steffensen KD. Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study. BMJ Open. 2023 Nov 14;13(11):e073900. doi: 10.1136/bmjopen-2023-073900.
- 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.
Helene Würtz, MD principal investigator
Vejle Hospital, Center for Shared Decision Making and Surgical Department
Karina D Steffensen, Prof PhD MD study chair
Center For Shared Decision Making, Vejle Hospital
Hans B Rahr, Prof Dr MD study chair
Surgical Department, Vejle Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shared Decision Making using a Patient Decision Aid. in people with Shared Decision Making and Colonic Polyp, run by Vejle Hospital.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Helene Würtz, MD (+4579405623, helene.juul.wurtz3@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. (time frame: 30 days). 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 NCT05776381, 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 30 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.