The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shared Decision Making using a Patient Decision Aid..
- Who it may be relevant to
- Registry conditions: Shared Decision Making, Colonic Polyp, Decision Aids, Rectal Polyp. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- 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.
Primary outcome measures
- Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. [Time frame: 30 days]
Secondary outcome measures (10)
- 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]
- Number of patients with postoperative morbidity 30 days after surgery [Time frame: 30 days postoperatively]
- Number of patients with postoperative mortality 30 days after surgery [Time frame: 30 days postoperatively]
- Number of patients with postoperative morbidity 90 days after surgery [Time frame: 90 days postoperatively]
- Number of patients with postoperative mortality 90 days after surgery [Time frame: 90 days postoperatively]
- Number of patients with recurrence 3 years after cancer diagnosis [Time frame: 3 years]
- Overall survival 3 years after cancer diagnosis [Time frame: 3 years]
- Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [Time frame: 24 hours after clinical encounter]
- Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [Time frame: 3 months after clinical encounter]
- Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [Time frame: 6 months after clinical encounter]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Wurtz HJ, Rahr HB, Lindebjerg J, Edwards A, Steffensen KD. Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study. BMJ Open. 2023 Nov 14;13(11):e073900. doi: 10.1136/bmjopen-2023-073900. PMID 37963688
Identifiers
NCT: NCT05776381 · SDM in malignant polyps