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

Sponsor
Vejle Hospital
Study ID
NCT05776381
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Mar 20, 2023
Start date
Feb 1, 2028
Status verified
Apr 2026
Primary completion
Jan 1, 2030
Completion
Feb 1, 2033

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Shared Decision Making (SDM)
    Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.
  • 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.

Primary Outcome Measure

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

Central Contacts

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