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

Primary Purpose

Shared Decision Making, Colonic Polyp, Decision Aids

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Shared Decision Making using a Patient Decision Aid.
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shared Decision Making focused on measuring non-randomized trial, malignant colorectal polyp, Patient Decision aid, Shared Decision Making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Shared Decision Making (SDM)

    Historical data arm

    Arm Description

    Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.
    Number of patients with postoperative morbidity 30 days after surgery
    Number of patients with postoperative mortality 30 days after surgery
    Number of patients with postoperative morbidity 90 days after surgery
    Number of patients with postoperative mortality 90 days after surgery
    Number of patients with recurrence 3 years after cancer diagnosis
    Overall survival 3 years after cancer diagnosis
    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.
    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.
    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.

    Full Information

    First Posted
    March 2, 2023
    Last Updated
    May 11, 2023
    Sponsor
    Vejle Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05776381
    Brief Title
    The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    February 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vejle Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp, Colorectal Polyp, Colorectal Cancer
    Keywords
    non-randomized trial, malignant colorectal polyp, Patient Decision aid, Shared Decision Making

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    The study is a clinical multicenter, non-randomized, interventional phase II study. Three to five departments of colorectal surgery in Danish hospitals will be invited to participate in the study.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Shared Decision Making (SDM)
    Arm Type
    Experimental
    Arm Description
    Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.
    Arm Title
    Historical data arm
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Shared Decision Making using a Patient Decision Aid.
    Intervention Description
    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 Outcome Measure Information:
    Title
    Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Number of patients with postoperative morbidity 30 days after surgery
    Time Frame
    30 days postoperatively
    Title
    Number of patients with postoperative mortality 30 days after surgery
    Time Frame
    30 days postoperatively
    Title
    Number of patients with postoperative morbidity 90 days after surgery
    Time Frame
    90 days postoperatively
    Title
    Number of patients with postoperative mortality 90 days after surgery
    Time Frame
    90 days postoperatively
    Title
    Number of patients with recurrence 3 years after cancer diagnosis
    Time Frame
    3 years
    Title
    Overall survival 3 years after cancer diagnosis
    Time Frame
    3 years
    Title
    Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
    Description
    Score range 1-100. The higher the score, the better the quality of life.
    Time Frame
    24 hours after clinical encounter
    Title
    Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
    Description
    Score range 1-100. The higher the score, the better the quality of life.
    Time Frame
    3 months after clinical encounter
    Title
    Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
    Description
    Score range 1-100. The higher the score, the better the quality of life.
    Time Frame
    6 months after clinical encounter

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Helene Würtz, MD
    Phone
    +4579405623
    Email
    helene.juul.wurtz3@rsyd.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helene Würtz, MD
    Organizational Affiliation
    Vejle Hospital, Center for Shared Decision Making and Surgical Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Karina D Steffensen, Prof PhD MD
    Organizational Affiliation
    Center For Shared Decision Making, Vejle Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hans B Rahr, Prof Dr MD
    Organizational Affiliation
    Surgical Department, Vejle Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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