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

Phase 2

Not yet recruiting

• Conditions: Colonic Polyp; Decision Aids; Colorectal Cancer; Rectal Polyp; Shared Decision Making; Colorectal Polyp
• Interventions: Other: Shared Decision Making using a Patient Decision Aid.

• Registration Number: NCT05776381
• Lead Sponsor: Vejle Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Study Start: 2026-02-01
• Primary Completion: 2027-01-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shared Decision Making (SDM)	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.

Primary Outcome Measures

Name	Time	Method
Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.	30 days

Secondary Outcome Measures

Name	Time	Method
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.
Number of patients with recurrence 3 years after cancer diagnosis	3 years
Number of patients with postoperative mortality 90 days after surgery	90 days postoperatively
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 morbidity 90 days after surgery	90 days postoperatively
Overall survival 3 years after cancer diagnosis	3 years
Number of patients with postoperative mortality 30 days after surgery	30 days postoperatively
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.