Primary Care Transfer for Thyroid Cancer Patients

NCT03794375 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2024-10-03

No results posted yet for this study

Summary

Introduction: Differentiated thyroid cancer (DTC) is the most common endocrine malignancy. It presents low recurrence rates (2-5%) and the consensus of DTC recommends long-term follow-up, without a definition of maximum follow-up time. The use of Telehealth is a strategy that aims to optimize the transition of care for patients from tertiary care to primary health care, helping to follow up these patients.

Objective: To evaluate the impact of the care transition between specialized care and primary health care of patients with DTC using telemedicine solutions.

Design / Patients: Randomized clinical trial. Patients with DTC with excellent response (without evidence of disease) after initial treatment.

Interventions / Outcomes: Patients will be randomized to follow-up in face-to-face consultations in tertiary care or transfer of care to primary care with support from the Telehealth Center of Rio Grande do Sul. After 18 months, all patients will be evaluated, the primary outcome being DTC recurrence rate. Outcomes related to quality of life and use of the health system will also be evaluated. Both follow-up strategies are expected to be equivalent, making it possible to optimize the use of the health system.

Conditions

  • Differentiated Thyroid Cancer

Interventions

OTHER

Telehealth

After 45 days after the estimated date of the consultation (6 months after discharge), the Telehealth staff will contact the patient to check if the consultation was actually performed. When individuals report difficulty accessing the unit, contact will be made to the primary care teams and the Telehealth staff will schedule the appointment. A new contact will be made in 12 months to verify if the consultation was actually performed.

OTHER

Usual care

The patients will remain in care at the HCPA thyroid disease outpatient clinic during the study period. This follow-up will be done by endocrinologists, and the patients will undergo clinical, biochemical (TSH, thyroglobulin, and antithyroglobulin) and radiological (cervical ultrasound) tests to seek disease recurrence. The patient's consultation will be done one or twice a year.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Rafael S. Scheffel, MD, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794375 on ClinicalTrials.gov