Cognition and QoL After Thyroid Surgery

Thyroid Cancer Clinical Trial

Official title:

Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088187
• Other study ID #: CogniThyr
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2023
• Source: Karolinska University Hospital
• Contact: Renske Altena, MD PhD
• Phone: +46724698719
• Email: renske.altena[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The development of cognitive dysfunction can profoundly affect HR-QoL as well as the possibility of societal participation and ability to work, and thereby relevantly impacts prospects for cancer survivorship. The aim of the study is to obtain improved understanding of the scope and magnitude of objective cognitive dysfunction in DTC survivors, and its relation to subjective cognitive dysfunction, thyroid hormone levels, physical activity and HRQoL. This is done in a prospective study where patients operated for a thyroid nodule (Bethesda IV-VI, i.e., benign [goitre with nodule and fibroadenomas], low-risk DTC and intermediate-high risk DTC) are included and asked to serially perform online neuropsychological testing as well as to complete questionnaires related to HR-QoL, physical activity and additional psychological and physical complaints. Blood is analysed for levels of thyroid hormones and systemic inflammation.

Description:

The primary aim of this study is to prospectively assess objective cognitive functioning in patients undergoing thyroid surgery for different indications by means of an online neuropsychological test, the Amsterdam Cognition Scale (ACS).

Three patient groups are defined; 1) patients with follicular adenomas, 2) patients with extreme low-risk differentiated thyroid cancer (DTC; pT1a and pN0/x tumours), 3) patients in all other DTC risk groups (i.e., low, intermediate and high-risk). The primary comparison confers to groups 1 and 3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years old, indication for surgery because of a thyroid nodule Bethesda IV-VI

• Able to read and understand the Swedish language

• Access to desktop computer or laptop with internet connection

• Able and willing to provide written informed consent

Exclusion Criteria:

• A previous diagnosis of (auto-immune) hypothyroidism

• A previous cancer diagnosis (excluding basal cell cancer of the skin)

• Indications for surgery other than (solely) a thyroid nodule (i.e., concomitant Graves)

• A diagnosis of medullary and anaplastic thyroid cancer

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Neurobehavioral Manifestations
• Survivorship
• Symptoms, Cognitive
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Nodule

Locations

Country	Name	City	State
Sweden	Medical Unit Breast-, Endocrine tumors and Sarcoma	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	The Netherlands Cancer Institute

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS)	change in total score on ACS	pre-surgery to 12 months post-surgery