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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05776381
Other study ID # SDM in malignant polyps
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2024
Est. completion date February 1, 2029

Study information

Verified date January 2024
Source Vejle Hospital
Contact Helene Würtz, MD
Phone +4579405623
Email helene.juul.wurtz3@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date February 1, 2029
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Shared 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vejle Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. 30 days
Secondary Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data. 45 days
Secondary Number of patients with postoperative morbidity 30 days after surgery 30 days postoperatively
Secondary Number of patients with postoperative mortality 30 days after surgery 30 days postoperatively
Secondary Number of patients with postoperative morbidity 90 days after surgery 90 days postoperatively
Secondary Number of patients with postoperative mortality 90 days after surgery 90 days postoperatively
Secondary Number of patients with recurrence 3 years after cancer diagnosis 3 years
Secondary Overall survival 3 years after cancer diagnosis 3 years
Secondary 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. 24 hours after clinical encounter
Secondary 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. 3 months after clinical encounter
Secondary 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. 6 months after clinical encounter
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