Primary Care Transfer for Thyroid Cancer Patients

NCT03794375 | Active Not Recruiting

• 1 other identifier: 95392418300005327
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Follow-up; Telehealth; Recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  All patients will be evaluated by the study team after completing 18 months of follow-up for this outcome. The presence of recurrence may be identified as a structural disease (evaluated by clinical examination and cervical ultrasound) or biochemical (evaluated by laboratory tests -thyroglobulin and antithyroglobulin antibody levels measurement). Both types of recurrence will be classified as an outcome.

  18 months

Secondary Outcomes (4)

• Patient's satisfaction evaluated by analogue-visual scale from 0 to 10.

  18 months

• Health care system access evaluated by the number of procedures related to the DTC performed by the patient.

  18 months

• Hypothyroidism control evaluated by the TSH level during the follow-up of the patients.

  18 months

• Quality of life evaluated by EuroQol-5D (EQ-5D)

  18 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

Telehealth

EXPERIMENTAL

The patients will be discharged from the HCPA thyroid disease outpatient clinic, being instructed to seek the primary care level according to their place of residence to schedule a routine consultation in up to six months. 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: Telehealth

Interventions

Telehealth OTHER

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.

Telehealth

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnostic of differentiated thyroid cancer and an excellent response to the initial treatment.

You may not qualify if:

• Definitive postoperative hypoparathyroidism.
• Postoperative vocal cord paralysis requiring tracheostomy.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

MeSH Terms

Conditions

Recurrence

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Rafael S. Scheffel, MD, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 7, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

BR (1)