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NCT Number: NCT05088187

Cognition and QoL After Thyroid Surgery

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.

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Key information

Conditions

Thyroid Nodule Cognition Disorders Cognitive Decline Cognitive Dysfunction Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Survivorship Symptoms, Cognitive Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Unit Breast-, Endocrine tumors and Sarcoma

Stockholm, 17176, Sweden

Location status: Recruiting

Location contact

Renske Altena, MD PhD

CONTACT

[email protected]

+46812375518

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: pre-surgery to 12 months post-surgery

    change in total score on ACS

Study contacts

Contact information is provided by the study sponsor or research team.

Cia Ihre Lundgren, MD Ass Professor

CONTACT

Renske Altena, MD PhD

CONTACT

[email protected]

+46724698719

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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