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

Sponsor

Vejle Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05776381

Collaborator

(none)

110

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shared Decision Making Colonic Polyp Decision Aids Rectal Polyp Colorectal Polyp Colorectal Cancer	Other: Shared Decision Making and Patient Decision Aid	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Feb 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient Decision Aid (PtDA) and Shared Decision Making (SDM) Patients with an unexpected malignant colorectal polyp in the consultation where a decision needs to be made concerning the management of care.	Other: Shared Decision Making and Patient Decision Aid The intervention comprises the surgeon actively using SDM and the tailored in-consultation PtDA with the patient in the consultation concerning the management of an unexpected malignant colorectal polyp.
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.

Arm

Intervention/Treatment

Experimental: Patient Decision Aid (PtDA) and Shared Decision Making (SDM)

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

Other: Shared Decision Making and Patient Decision Aid

The intervention comprises the surgeon actively using SDM and the tailored in-consultation PtDA with the patient in the consultation concerning the management of an unexpected malignant colorectal polyp.

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.

Outcome Measures

Primary Outcome Measures

Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. [30 days]

Secondary Outcome Measures

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. [24 hours after clinical encounter]
Score range 1-100. The higher the score, the better the quality of life.
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [3 months after clinical encounter]
Score range 1-100. The higher the score, the better the quality of life.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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