Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility outcomes
研究概览
简要总结
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.
详细描述
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:
- Develop a digital health-based thyroid cancer assessment reminder system alerting patients and PCPs of patients' forthcoming appointment and guidelines.
- Establish an expedited referral pathway to tertiary care for rapid assessment of patients discharged to PCPs in case of a risk of recurrence.
- Identify the feasibility of the Shared-care model.
- Compare the completion of the clinical assessments between Shared-care and Control Groups.
- Compare patient and provider satisfaction and acceptability between Shared-care and Control Groups.
- Compare PCP confidence in dealing with DTC before and after study completion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient does not have a consented PCP.
结局指标
主要结局
Feasibility outcomes
时间窗: after up to 24 months (after the 2nd Follow-up)
These outcomes will assess the feasibility of the pilot study. These include: * Number (%) of eligible patients who are approached for the study and agree to participate in either group. * Number (%) of eligible patients who are are approached for the study but refuse to participate in either group and reason for refusal. * Number (%) of patients who remain in the shared-care group at study end. * Number of patients who choose to terminate the study in either group and reason for termination. * Number of patients who lost their PCP and returned to specialist care.
DTC shared-care outcomes
时间窗: after up to 24 months (after the 2nd Follow-up)
These outcomes will be measured to compare shared-care vs control DTC patients during the study duration and prospectively entered into a computerized DTC outcome registry of all study patients to follow their progress. This will be separate from TCARS, which will contain no clinical information.This information will be entered by the study coordinator. These include: * Number (%) of patients having annual TG/anti-TG AB. * Number (%) of patients having annual neck ultrasound. * Number (%) of patients with TSH test every 6 months. * Number (%) of patients with TSH within target range and if outside target, whether thyroxine dose was adjusted and TSH rechecked. * Number (%) of patients with abnormal findings on neck ultrasound or TG/anti-TG AB test. * Number (%) of patients who were referred back to ITOC using the expedited referral sheet and reason for referral.
次要结局
- Patient and provider acceptability and experience outcomes(after up to 24 months (after 2nd Follow-up))
- Patient satisfaction outcomes(after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up))
- PCP confidence in DTC management outcomes(after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up))