Идёт набор NCT05510934

Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.

— Наблюдательное Low Risk Differentiated Thyroid Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Shared-care model.
Кому может быть актуально: Состояния в реестре: Low Risk Differentiated Thyroid Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study aims to assess the feasibility of a shared-care model for low-risk differentiated thyroid cancer (DTC) patients, primary care practitioners (PCPs) and the tertiary care center utilizing a digital health-based thyroid cancer assessment reminder system (TCARS) in Medable with an expedited referral to specialists for rapid assessment in case of a concern of recurrence.

Подробное описание

Low risk differentiated thyroid cancer (DTC) is being increasingly diagnosed and although its overall survival is excellent, lifelong follow-up is needed due to the risk of ongoing health challenges and the cancer recurring. While it is not feasible to follow this growing number of patients in specialist centers due to limited resources, recent studies have suggested that simply discharging them to their PCP is not ideal because many PCPs do not feel confident in managing various aspects of DTC. More importantly, a large number of patients in Nova Scotia do not have regular access to PCPs and are thus followed by walk-in clinics or nurse practitioners.The optimal approach would therefore be, to establish a shared care follow-up model including participation from patients, primary care practitioners (PCPs) and specialists.

In this study, the feasibility of a shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system will be tested. This strategy will be compared to standard specialist only follow-up. The study population comprises 60 low risk adult DTC patients who will be randomly allocated to either Shared-care or Control group on a 1:1 basis (30 patients each).

The main objectives of this study is to:

1. Develop a digital health-based thyroid cancer assessment reminder system alerting patients and PCPs of patients' forthcoming appointment and guidelines. 2. Establish an expedited referral pathway to tertiary care for rapid assessment of patients discharged to PCPs in case of a risk of recurrence. 3. Identify the feasibility of the Shared-care model. 4. Compare the completion of the clinical assessments between Shared-care and Control Groups. 5. Compare patient and provider satisfaction and acceptability between Shared-care and Control Groups. 6. Compare PCP confidence in dealing with DTC before and after study completion.

Вмешательства

Поведенческое Shared-care model
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).

Первичные конечные точки

Feasibility outcomes [Срок оценки: after up to 24 months (after the 2nd Follow-up)]
DTC shared-care outcomes [Срок оценки: after up to 24 months (after the 2nd Follow-up)]

Вторичные конечные точки (3)

Patient satisfaction outcomes [Срок оценки: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)]
Patient and provider acceptability and experience outcomes [Срок оценки: after up to 24 months (after 2nd Follow-up)]
PCP confidence in DTC management outcomes [Срок оценки: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)]

Критерии участия

Критерии включения

Adult (>18 years old) consenting patients being followed at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC) meeting the following criteria:

AJCC stage 1 DTC with no radiological or biochemical evidence of thyroid cancer with undetectable high sensitivity serum thyroglobulin (hsTG <0.06 mcg/L\*);
Anti-thyroglobulin antibody (anti-TG AB <20 IU/ml\*);
Thyroid ultrasound scan \[USS\] negative for regional recurrence at least 24 months after most recent treatment;
AJCC stage 2 DTC with no radiological or biochemical evidence of cancer (undetectable hsTG and anti-TG AB and negative thyroid USS) at least 48 months after most recent treatment
Patient is comfortable with using the mobile or Medable application and has access to internet.