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

Vejle Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Colonic Polyp; Colorectal Polyp; Shared Decision Making; Rectal Polyp; Decision Aids; Colorectal Cancer

Treatments: Other: Shared Decision Making using a Patient Decision Aid.

Study type: Interventional

Funder types: Other

Identifiers

NCT05776381

SDM in malignant polyps

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Shared Decision Making (SDM)

Experimental group

Description:

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

Treatment:

Other: Shared Decision Making using a Patient Decision Aid.

Historical data arm

No Intervention group

Description:

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.