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Trial Title:
Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
NCT ID:
NCT05510934
Condition:
Low Risk Differentiated Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
low risk DTC
Shared-care model
decentralized clinical trial (DCT)
DTC
Thyroid Cancer
Feasibility Study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Shared-care model
Description:
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an
automated reminder system (TCARS).
Arm group label:
Shared-care Group
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.
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.
Criteria for eligibility:
Study pop:
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 .
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nova Scotia Health
Address:
City:
Halifax
Zip:
B2Y 1A7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Glenda McCarthy
Phone:
(902) 473-4997
Email:
glenda.mccarthy@nshealth.ca
Start date:
September 30, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Nova Scotia Health Authority
Agency class:
Other
Source:
Nova Scotia Health Authority
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510934