NCT05088187

Cognition and QoL After Thyroid Surgery

StatusUnknown

PhaseNot specified

SponsorKarolinska University Hospital

Primary completionNov 1, 2023 (estimated)

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Record History

All 2 versions: 2 with changes below.

Minor Changed Nov 8, 2026 Registry marked status Unknown (sponsor has not verified the record since Jan 2023); last known: Recruiting
Notable Jan 16, 2023 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Nov 1, 2021 to Jan 17, 2023
- Study sites: 0 to 1
v2
Oct 11, 2021 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS)

Timeframe: pre-surgery to 12 months post-surgery

Sites

1 site in 1 country

Medical Unit Breast-, Endocrine tumors and SarcomaStockholm, Sweden

About this trial

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.

Trial details

Enrollment: 320 participants (estimated)
Started: Jan 17, 2023
Study completion: Nov 1, 2026 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Cognitive Dysfunction, Neurobehavioral Manifestations, Thyroid Neoplasms, Thyroid Nodule, Thyroid Cancer, Cognitive Decline, Survivorship, Symptoms, Cognitive
Collaborators: The Netherlands Cancer Institute
Official title: Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
First posted: Oct 21, 2021
Registry updated: Jan 18, 2023
Last verified: Jan 2023
Record status: This record was last updated January 18, 2023 (before its estimated November 1, 2023 completion). Its status may not reflect the trial's current state.

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