Cognition and QoL After Thyroid Surgery

NCT ID: NCT05088187

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2026-11-01

Brief Summary

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.

Conditions

Thyroid Nodule; Thyroid Cancer; Cognitive Decline; Survivorship; Symptoms, Cognitive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Renske Altena

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renske Altena, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Medical Unit Breast-, Endocrine tumors and Sarcoma

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Renske Altena, MD PhD

Role: CONTACT

renske.altena@ki.se

+46724698719

Cia Ihre Lundgren, MD Ass Professor

Role: CONTACT

Facility Contacts

Renske Altena, MD PhD

Role: primary

renske.altena@ki.se

+46812375518

Other Identifiers

CogniThyr

Identifier Type: -

Identifier Source: org_study_id