Colonic Polyp, Colorectal Cancer, Colorectal Polyp, Decision Aids, Rectal Polyp, Shared Decision Making
Conditions
Keywords
non-randomized trial, malignant colorectal polyp, Patient Decision aid, Shared Decision Making
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.
Interventions
OTHERShared Decision Making using a Patient Decision Aid.
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.
Sponsors
Vejle Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data. | 45 days | — |
| Number of patients with postoperative morbidity 30 days after surgery | 30 days postoperatively | — |
| Number of patients with postoperative mortality 30 days after surgery | 30 days postoperatively | — |
| Number of patients with postoperative morbidity 90 days after surgery | 90 days postoperatively | — |
| Number of patients with postoperative mortality 90 days after surgery | 90 days postoperatively | — |
| Number of patients with recurrence 3 years after cancer diagnosis | 3 years | — |
| Overall survival 3 years after cancer diagnosis | 3 years | — |
| Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. | 24 hours after clinical encounter | 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. | 3 months after clinical encounter | Score range 1-100. The higher the score, the better the quality of life. |
Contacts
CONTACTHelene Würtz, MD
PRINCIPAL_INVESTIGATORHelene Würtz, MD
Vejle Hospital, Center for Shared Decision Making and Surgical Department
STUDY_CHAIRKarina D Steffensen, Prof PhD MD
Center For Shared Decision Making, Vejle Hospital
STUDY_CHAIRHans B Rahr, Prof Dr MD
Surgical Department, Vejle Hospital
Outcome results
None listed