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

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 Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Colonic Polyp; Colorectal Polyp; Shared Decision Making; Decision Aids; Rectal Polyp
• Intervention / Treatment: Other: Shared Decision Making using a Patient Decision Aid.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Helene Würtz, MD; Phone Number: +4579405623; Email: helene.juul.wurtz3@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Historical data arm; 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.
Experimental: Shared Decision Making (SDM); 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Principal Investigator: Helene Würtz, MD, Vejle Hospital, Center for Shared Decision Making and Surgical Department; Study Chair: Karina D Steffensen, Prof PhD MD, Center For Shared Decision Making, Vejle Hospital; Study Chair: Hans B Rahr, Prof Dr MD, Surgical Department, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Shared Decision Making; non-randomized trial; malignant colorectal polyp; Patient Decision aid
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: SDM in malignant polyps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No