Clinical trial NCT05776381: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

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.


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

Primary outcomes:
measure: Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
timeFrame: 30 days
Secondary outcomes:
measure: Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.
timeFrame: 45 days
measure: Number of patients with postoperative morbidity 30 days after surgery
timeFrame: 30 days postoperatively
measure: Number of patients with postoperative mortality 30 days after surgery
timeFrame: 30 days postoperatively
measure: Number of patients with postoperative morbidity 90 days after surgery
timeFrame: 90 days postoperatively
measure: Number of patients with postoperative mortality 90 days after surgery
timeFrame: 90 days postoperatively
measure: Number of patients with recurrence 3 years after cancer diagnosis
timeFrame: 3 years
measure: Overall survival 3 years after cancer diagnosis
timeFrame: 3 years
measure: Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
timeFrame: 24 hours after clinical encounter
measure: Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
timeFrame: 3 months after clinical encounter
measure: Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.
timeFrame: 6 months after clinical encounter
Other outcomes:
Locations:
Study officials:
affiliation: Vejle Hospital, Center for Shared Decision Making and Surgical Department
name: Helene Würtz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center For Shared Decision Making, Vejle Hospital
name: Karina D Steffensen, Prof PhD MD
role: STUDY_CHAIR
affiliation: Surgical Department, Vejle Hospital
name: Hans B Rahr, Prof Dr MD
role: STUDY_CHAIR
References: