Cognition and QoL After Thyroid Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Thyroid Nodule, Thyroid Cancer, Cognitive Decline, Survivorship. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
Overview
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.
Primary outcome measures
- Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS) [Time frame: pre-surgery to 12 months post-surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Medical Unit Breast-, Endocrine tumors and Sarcoma — Stockholm
Identifiers
NCT: NCT05088187 · CogniThyr