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NCT Number: NCT05776381

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

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.

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Key information

Conditions

Shared Decision Making Colonic Diseases Colonic Polyp Colonic Polyps Colorectal Cancer Colorectal Neoplasms Colorectal Polyp Decision Aids Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases Rectal Polyp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.

    Time frame: 30 days

Secondary outcomes

  1. Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.

    Time frame: 45 days

  2. Number of patients with postoperative morbidity 30 days after surgery

    Time frame: 30 days postoperatively

  3. Number of patients with postoperative mortality 30 days after surgery

    Time frame: 30 days postoperatively

  4. Number of patients with postoperative morbidity 90 days after surgery

    Time frame: 90 days postoperatively

  5. Number of patients with postoperative mortality 90 days after surgery

    Time frame: 90 days postoperatively

  6. Number of patients with recurrence 3 years after cancer diagnosis

    Time frame: 3 years

  7. Overall survival 3 years after cancer diagnosis

    Time frame: 3 years

  8. Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.

    Time frame: 24 hours after clinical encounter

    Score range 1-100. The higher the score, the better the quality of life.

  9. Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.

    Time frame: 3 months after clinical encounter

    Score range 1-100. The higher the score, the better the quality of life.

  10. Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.

    Time frame: 6 months after clinical encounter

    Score range 1-100. The higher the score, the better the quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Helene Würtz, MD

CONTACT

[email protected]

+4579405623

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study 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

Important dates

Study start
2028
Primary completion
2030
Study completion
2033
First posted
Mar 20, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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