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

NCT05776381 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SDM in malignant polyps
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

non-randomized trial; malignant colorectal polyp; Patient Decision aid; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.

  30 days

Secondary Outcomes (10)

• 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

Study Arms (2)

Shared Decision Making (SDM)

EXPERIMENTAL

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.

Historical data arm

NO INTERVENTION

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.

Interventions

Shared Decision Making using a Patient Decision Aid. OTHER

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 (SDM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent
• Inoperable due to comorbidity
• Known residual tumor left in situ after local resection, \>N0 or \>M0

Sponsors & Collaborators

• Vejle Hospital: lead

Related Publications (1)

• Wurtz HJ, Rahr HB, Lindebjerg J, Edwards A, Steffensen KD. Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study. BMJ Open. 2023 Nov 14;13(11):e073900. doi: 10.1136/bmjopen-2023-073900.

  PMID: 37963688 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Helene Würtz, MD

  Vejle Hospital, Center for Shared Decision Making and Surgical Department

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Helene Würtz, MD

CONTACT

+4579405623; helene.juul.wurtz3@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 20, 2023
• Study Start (Estimated): February 1, 2028
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): February 1, 2033
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share