Symptoms and General Pathology

All Conditions

Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Intestinal Polyps

Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.

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.

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.

Shared Decision Making using a Patient Decision Aid.

Helene Würtz, MD

Karina D Steffensen, Prof PhD MD

Hans B Rahr, Prof Dr MD

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.

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.

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

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

Score range 1-100. The higher the score, the better the quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp	NCT05776381	Shared Decision... Colonic Polyp Decision Aids Rectal Polyp Colorectal Poly... Colorectal Canc...	Shared Decision...	18 Years -	Vejle Hospital
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp	NCT05776381	Shared Decision... Colonic Polyp Decision Aids Rectal Polyp Colorectal Poly... Colorectal Canc...	Shared Decision...	18 Years -	Vejle Hospital

Spots Global Cancer Trial Database for shared decision making using a patient decision aid.