The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. [Срок оценки: 30 days]

Вторичные конечные точки (10)

• Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data. [Срок оценки: 45 days]
• Number of patients with postoperative morbidity 30 days after surgery [Срок оценки: 30 days postoperatively]
• Number of patients with postoperative mortality 30 days after surgery [Срок оценки: 30 days postoperatively]
• Number of patients with postoperative morbidity 90 days after surgery [Срок оценки: 90 days postoperatively]
• Number of patients with postoperative mortality 90 days after surgery [Срок оценки: 90 days postoperatively]
• Number of patients with recurrence 3 years after cancer diagnosis [Срок оценки: 3 years]
• Overall survival 3 years after cancer diagnosis [Срок оценки: 3 years]
• Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [Срок оценки: 24 hours after clinical encounter]
• Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [Срок оценки: 3 months after clinical encounter]
• Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. [Срок оценки: 6 months after clinical encounter]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Inability to provide informed consent
• Inoperable due to comorbidity
• Known residual tumor left in situ after local resection, >N0 or >M0

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT05776381 · SDM in malignant polyps

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗