To hear about similar clinical trials, please enter your email below
Trial Title:
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp
NCT ID:
NCT05776381
Condition:
Shared Decision Making
Colonic Polyp
Decision Aids
Rectal Polyp
Colorectal Polyp
Colorectal Cancer
Conditions: Official terms:
Polyps
Colonic Polyps
Conditions: Keywords:
non-randomized trial
malignant colorectal polyp
Patient Decision aid
Shared Decision Making
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Shared Decision Making using a Patient Decision Aid.
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.
Arm group label:
Shared Decision Making (SDM)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
February 1, 2029
Lead sponsor:
Agency:
Vejle Hospital
Agency class:
Other
Source:
Vejle Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05776381
