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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp, Colorectal Polyp, Colorectal Cancer

Intervention / Treatment
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* Other: Shared Decision Making using a Patient Decision Aid.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared Decision Making (SDM)<br>Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care. | Other: Shared Decision Making using a Patient Decision Aid.<br>* 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.<br>|
| No Intervention: Historical data arm<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Score range 1-100. The higher the score, the better the quality of life. | 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. | 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. | 6 months after clinical encounter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-randomized trial, malignant colorectal polyp, Patient Decision aid, Shared Decision Making