Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedAugust 21, 2024
August 1, 2024
3 years
July 29, 2022
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility outcomes
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.
after up to 24 months (after the 2nd Follow-up)
DTC shared-care outcomes
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.
after up to 24 months (after the 2nd Follow-up)
Secondary Outcomes (3)
Patient satisfaction outcomes
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
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)
Other Outcomes (1)
DCT (Medable) specific outcomes
after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Study Arms (2)
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.
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).
Interventions
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).
Eligibility Criteria
Control group = 30 patients, where 15 patients are from the Nova Scotia central zone, and 15 patients are from the Nova Scotia non-central zone. Shared-care group = 30 patients, where 15 patients are from the Nova Scotia central zone, and patients are from the Nova Scotia non-central zone .
You may qualify if:
- 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.
You may not qualify if:
- Patient does not have a consented PCP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nova Scotia Health
Halifax, Nova Scotia, B2Y 1A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Syed A. Imran, Dr.
Nova Scotia Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 22, 2022
Study Start
September 30, 2022
Primary Completion
September 30, 2025
Study Completion
December 30, 2025
Last Updated
August 21, 2024
Record last verified: 2024-08