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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05776381
• Other study ID #: SDM in malignant polyps
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2024
• Est. completion date: February 1, 2029

Study information

• Verified date: January 2024
• Source: Vejle Hospital
• Contact: Helene Würtz, MD
• Phone: +4579405623
• Email: helene.juul.wurtz3[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 1, 2029
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colorectal Cancer
• Colorectal Polyp
• Decision Aids
• Polyps
• Rectal Polyp
• Shared Decision Making

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.		30 days
Secondary	Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.		45 days
Secondary	Number of patients with postoperative morbidity 30 days after surgery		30 days postoperatively
Secondary	Number of patients with postoperative mortality 30 days after surgery		30 days postoperatively
Secondary	Number of patients with postoperative morbidity 90 days after surgery		90 days postoperatively
Secondary	Number of patients with postoperative mortality 90 days after surgery		90 days postoperatively
Secondary	Number of patients with recurrence 3 years after cancer diagnosis		3 years
Secondary	Overall survival 3 years after cancer diagnosis		3 years
Secondary	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
Secondary	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
Secondary	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