Understanding cognitive function and quality of life after thyroid surgery
Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
This study looks at how thyroid surgery affects thinking skills and quality of life in patients with different thyroid conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05088187 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cognitive dysfunction in patients who have undergone thyroid surgery for various conditions, including benign nodules and differentiated thyroid cancer. Participants will complete online neuropsychological tests and questionnaires related to their health-related quality of life (HR-QoL), physical activity, and psychological complaints. Blood samples will be analyzed for thyroid hormone levels and markers of systemic inflammation. The study will categorize patients into three groups based on their thyroid conditions to evaluate differences in cognitive outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing surgery for thyroid nodules classified as Bethesda IV-VI.
Not a fit: Patients with a previous diagnosis of autoimmune hypothyroidism or other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into cognitive health and quality of life improvements for thyroid cancer survivors.
How similar studies have performed: While cognitive dysfunction post-thyroid surgery has been explored, this study's specific focus on objective cognitive assessment in differentiated thyroid cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm
- Medical Unit Breast-, Endocrine tumors and Sarcoma — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Renske Altena, MD PhD — Karolinska Institutet
- Study coordinator: Renske Altena, MD PhD
- Email: renske.altena@ki.se
- Phone: +46724698719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.