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

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jan 1, 2027 to Jan 1, 2030
    • Start date: Feb 1, 2026 to Feb 1, 2028
    • Study completion date: Feb 1, 2030 to Feb 1, 2033
    v6
  2. Notable Start date: Feb 1, 2025 to Feb 1, 2026v5
  3. Notable Primary completion date: Jan 1, 2026 to Jan 1, 2027
    • Start date: Sep 1, 2024 to Feb 1, 2025
    • Study completion date: Feb 1, 2029 to Feb 1, 2030
    v4
  4. Notable Primary completion date: Jan 1, 2025 to Jan 1, 2026
    • Start date: Dec 1, 2023 to Sep 1, 2024
    • Study completion date: Feb 1, 2028 to Feb 1, 2029
    v3
  5. Notable Phase: Not applicable to Phase 2
    • Interventions: Shared Decision Making and Patient Decision Aid (Other) to Shared Decision Making using a Patient Decision Aid. (Other)
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05776381
Lead Sponsor Vejle Hospital
Conditions
(from sponsor)
Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp, Colorectal Polyp, Colorectal Cancer
Related terms Colonic Polyps, Colorectal Neoplasms
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov