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Cognition and QoL After Thyroid Surgery

Sponsor
Karolinska University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05088187
Collaborator
The Netherlands Cancer Institute (Other)
320
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

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. Therefore, we aim 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. We plan to do this by performing 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    320 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
    Anticipated Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Nov 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS) [pre-surgery to 12 months post-surgery]

      change in total score on ACS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karolinska University Hospital
    • The Netherlands Cancer Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Renske Altena, MD PhD, Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT05088187
    Other Study ID Numbers:
    • CogniThyr
    First Posted:
    Oct 21, 2021
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Thyroid Nodule
    Neurobehavioral Manifestations
    Thyroid Diseases
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Oct 21, 2021