Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
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-care model.
- Who it may be relevant to
- Registry conditions: Low Risk Differentiated Thyroid Cancer. 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
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Behavioral Shared-care model
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).
Primary outcome measures
- Feasibility outcomes [Time frame: after up to 24 months (after the 2nd Follow-up)]
- DTC shared-care outcomes [Time frame: after up to 24 months (after the 2nd Follow-up)]
Secondary outcome measures (3)
- Patient satisfaction outcomes [Time frame: 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 [Time frame: after up to 24 months (after 2nd Follow-up)]
- PCP confidence in DTC management outcomes [Time frame: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
Patient does not have a consented PCP.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Nova Scotia Health — Halifax
Identifiers
NCT: NCT05510934 · TCARS-2022