HRQOL in Thyroid Cancer and Thyroid Tumours
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Oslo University Hospital (OUH) is a regional hospital. The Ear Nose and Throat (ENT) department is sharing the responsibility for diagnosis and treatment of thyroid cancer with one other location within OUH. Patients planned for thyroid surgery at the ENT department of OUH , will be asked to participate in the study. At the point of recruitment to the study, the final diagnosis in unknown for the doctor as well as the participant, as the result will come from histopathologcal examination of the surgery specimen. Participants will undergo standard work up for their thyroid tumour(s), and standard treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change in global HRQOL score
Change in global HRQOL score between start and at 12 months postoperatively after thyroid surgery. A change of more than 10% is set as a limit for a significant change.
Time frame
Circa 12 months from date of (last) thyroid surgery for the individual participantSecondary outcomes
1
Change in fatigue score
Change in fatigue score between start and at 12 months postoperatively after thyroid surgery. A change of more than 10% is set as a limit for a significant change.
Time frame
Circa 12 months from date of (last) thyroid surgery for the individual participant2
Change in HRQOL before and after radioiodine treatment
Change in HRQOL before and after radioiodine treatment.
Time frame
Circa 12 months from date of (last) thyroid surgery for the individual participant3
Change in HRQOL between participants With benign and malignant tumours
Change in HRQOL between participants With benign and malignant tumours.
Time frame
Circa 12 months from date of (last) thyroid surgery for the individual participantSponsors and contacts
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Source ClinicalTrials.gov