Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
NCT ID: NCT05510934
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2022-09-30
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Shared-care Group
The Shared-care Group will comprise of patients who are receiving long term follow-up care for their condition by their PCP.
Shared-care model
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).
Control Group
The Control Group will be made of patients who are receiving long term follow-up care for their condition of low-risk DTC at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC).
No interventions assigned to this group
Interventions
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Shared-care model
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Nova Scotia Health Authority
OTHER
Responsible Party
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Principal Investigators
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Syed A. Imran, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health
Locations
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Nova Scotia Health
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TCARS-2022
Identifier Type: -
Identifier Source: org_study_id
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