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Cognition and QoL After Thyroid Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05088187
Enrollment
320
Registered
2021-10-21
Start date
2023-01-17
Completion date
2026-11-01
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Survivorship, Symptoms, Cognitive, Thyroid Cancer, Thyroid Nodule

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

The Netherlands Cancer Institute
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS)pre-surgery to 12 months post-surgerychange in total score on ACS

Countries

Sweden

Contacts

Primary ContactRenske Altena, MD PhD
renske.altena@ki.se+46724698719
Backup ContactCia Ihre Lundgren, MD Ass Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026