Recruiting

Thyroid Cancer

Sponsor:

Nova Scotia Health Authority

Code:

NCT05510934

Conditions

Low Risk Differentiated Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shared-care model

Study Details

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.

Conditions

Low Risk Differentiated Thyroid Cancer

Study ID

NCT05510934

Start date

Sep 30, 2022

Status verified date

Aug, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Shared-care model

A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B2Y 1A7

Contacts

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Keywords

  • low risk DTC
  • Shared-care model
  • decentralized clinical trial (DCT)
  • DTC
  • Thyroid Cancer
  • Feasibility Study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.