The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp

NCT05776381 — Phase 2, Not yet recruiting, 110 participants, Vejle Hospital

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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

Registry	NCT05776381
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; non randomized, single group, masking: none, supportive care
Enrollment	110 (Estimated)
Sponsor	Vejle Hospital (Other)
Conditions	Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp, Colorectal Polyp, Colorectal Cancer
Interventions	Shared Decision Making using a Patient Decision Aid. (Other)
Dates	start 2028-02-01 (estimated), primary completion 2030-01-01 (estimated), completion 2033-02-01 (estimated), first posted 2023-03-20, last updated 2026-04-30

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

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.

+Outcome measures

Primary outcomes

Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. [30 days]

Secondary outcomes

Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data. [45 days]
Number of patients with postoperative morbidity 30 days after surgery [30 days postoperatively]
Number of patients with postoperative mortality 30 days after surgery [30 days postoperatively]
Number of patients with postoperative morbidity 90 days after surgery [90 days postoperatively]
Number of patients with postoperative mortality 90 days after surgery [90 days postoperatively]
Number of patients with recurrence 3 years after cancer diagnosis [3 years]
Overall survival 3 years after cancer diagnosis [3 years]
Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [24 hours after clinical encounter]: Score range 1-100. The higher the score, the better the quality of life.
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [3 months after clinical encounter]: Score range 1-100. The higher the score, the better the quality of life.
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [6 months after clinical encounter]: Score range 1-100. The higher the score, the better the quality of life.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inability to provide informed consent
* Inoperable due to comorbidity
* Known residual tumor left in situ after local resection, >N0 or >M0

+Publications

Results publication: 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. PMID 37963688

+Investigators

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