Vejle Hospital
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.
Shared Decision Making
Colonic Polyp
Decision Aids
Rectal Polyp
Colorectal Polyp
Colorectal Cancer
Shared Decision Making using a Patient Decision Aid.
PHASE2
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 110 participants |
| Masking : | NONE |
| 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 |
| Actual Study Start Date : | 2026-02-01 |
| Estimated Primary Completion Date : | 2027-01-01 |
| Estimated Study Completion Date : | 2030-02-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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