Actively Recruiting
Longitudinal Evaluation of Cognitive Function and Quality of Life After Surgery for Malignant and Benign Thyroid Nodules
Led by Karolinska University Hospital · Updated on 2023-01-18
320
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
K
Karolinska University Hospital
Lead Sponsor
T
The Netherlands Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying cognitive function and quality of life in people who have surgery for thyroid nodules. The study aims to understand the extent of objective cognitive problems and how they relate to subjective cognitive complaints, thyroid hormone levels, physical activity, and health-related quality of life. This prospective study includes patients with benign thyroid nodules, low-risk differentiated thyroid cancer, and intermediate to high-risk thyroid cancer. Participants are divided into three groups: those with follicular adenomas, those with very low-risk thyroid cancer, and those with low to high-risk thyroid cancer. The main comparison focuses on patients with follicular adenomas and those with higher-risk thyroid cancer. Cognitive function is assessed using an online neuropsychological test called the Amsterdam Cognition Scale (ACS). Participants complete online cognitive tests and questionnaires about quality of life, physical activity, and other psychological and physical symptoms at multiple times from before surgery up to 12 months after surgery. Blood samples are taken to measure thyroid hormone levels and signs of inflammation. The study measures objective cognitive function over time to better understand its impact on survivors of thyroid conditions.
CONDITIONS
Brief Title
Cognition and QoL After Thyroid Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Indication for surgery due to a thyroid nodule classified as Bethesda IV-VI
- Ability to read and understand the Swedish language
- Access to a desktop computer or laptop with internet connection
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Previous diagnosis of autoimmune hypothyroidism
- Previous cancer diagnosis except basal cell skin cancer
- Surgery indications other than solely a thyroid nodule (e.g., Graves disease)
- Diagnosis of medullary or anaplastic thyroid cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo thyroid surgery and receive immediate post-operative care.
1 hospital visit for surgery and immediate post-operative care
Duration - 12 months
Participants are followed for cognitive function and quality of life assessments after surgery.
Multiple online assessments over 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Medical Unit Breast-, Endocrine tumors and Sarcoma
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
R
Renske Altena, MD PhD
C
Cia Ihre Lundgren, MD Ass Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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