NCT03676348 HRQOL in Thyroid Cancer and Thyroid Tumours
| NCT ID | NCT03676348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Thyroid Nodule |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-01-25 |
| Primary Completion | 2023-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2018-01-25 with a primary completion date of 2023-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Most patients with thyroid cancer have a long life expectancy, and it has been assumed among health professionals that therefore the quality of life (QOL) is good. Some European studies have shown that the quality of life among thyroid cancers is worse than the general population, and almost as low as other cancer diagnoses, with a worse prognosis and a more burdening treatment. Aim: To examine prospectively the quality of life in participants undergoing diagnostic thyroid surgery and participants undergoing surgery for certain thyroid cancer. By examining both groups we wish to find answers if quality of life is affected, and if so - mostly affected by the diagnosis or the surgery itself. Methods: Participants enroll the study after informed consent, and quality of life will be assessed using quality of life questionnaires EORTC QLQ C30, EORTC THY 47 and EORTC FA12 before surgery, and 6 and 12 months after surgery. This study will form two main groups of participants; with and without thyroid cancer.
Eligibility Criteria
Inclusion Criteria: * planned hemi- or total thyroidectomy at the ENT-Department of Oslo University Hospital * tumour in the thyroid gland With fine needle aspiration results of Bethesda 3-6, or other clinical manifestations suspicious of cancer. * ability to understand and Complete the quesitionnaires * informed consent to participation Exclusion Criteria: * unable to Complete or understand the questionnaires * age below 18 years * thyroid surgery within the last 2 years * thyroid surgery on other indications than listed above * participants With postoperative external radiotherapy
Contact & Investigator
Terje A Osnes, MD, PhD
PRINCIPAL INVESTIGATOR
Professor otorhinolaryngology, Rikshospitalet, Oslo University Hospital. Head of department, otorhinolaryngology - head and neck surgery, Rikshospitalet, Oslo University Hospital
Frequently Asked Questions
Who can join the NCT03676348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Nodule. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03676348 currently recruiting?
Yes, NCT03676348 is actively recruiting participants. Contact the research team at b.m.lorntzsen@medisin.uio.no for enrollment information.
Where is the NCT03676348 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT03676348 clinical trial?
NCT03676348 is sponsored by Oslo University Hospital. The principal investigator is Terje A Osnes, MD, PhD at Professor otorhinolaryngology, Rikshospitalet, Oslo University Hospital. Head of department, otorhinolaryngology - head and neck surgery, Rikshospitalet, Oslo University Hospital. The trial plans to enroll 200 participants.