HRQOL in Thyroid Cancer and Thyroid Tumours

NCT ID: NCT03676348

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2028-04-30

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.

Detailed Description

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 QOL 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.

This study aims to examine the quality of life in patients undergoing diagnostic surgery for thyroid tumour(s), or thyroid surgery as part of a cancer treatment.

Participants will undergo standard work up and treatment for their thyroid tumour(s). Clinical data will be extracted from medical records at Oslo University Hospital (OUH). Questionnaires on Health related quality of life (HRQOL) are be filled out before surgery and at follow up visits at 6 and 12 months after surgery. Participants that do not meet at follow-up, will receive the questionnaires by mail.

At the end of the study there will be three subgroups of participants: (a) Benign tumour, (b) Malignant tumour with radioiodine treatment, (c) Malignant tumour without radioiodine treatment.

Questionnaires from European Organization for Research and Treatment of Cancer (EORTC) will be used, as they are well validated and relatively widely used. The EORTC QLQ C30 was chosen for a general view on HRQOL, as well as an available Norwegian general population for comparison. For a more disease specific questionnaire, the EORTC THY47 is used, a module of EORTC QLQ C30 on thyroid cancer. In addition we wish to capture a possibly important element in participants undergoing thyroid surgery, and where a fraction of participants may be hypothyroid for a period of time - therfore a fatigue module, the EORTC FA12 was added.

Calculations on sample size were performed by statistician R Sørum Falk at the Centre of Biostatistics and Epidemiology of Oslo University Hospital.

Intraobserver analysis of plotting and calculations is planned.

Conditions

Thyroid Nodule; Thyroid Cancer; Quality of Life

Study Design

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

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

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

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bianca M.R. Lorntzsen

MD, PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terje A Osnes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor otorhinolaryngology, Rikshospitalet, Oslo University Hospital. Head of department, otorhinolaryngology - head and neck surgery, Rikshospitalet, Oslo University Hospital

Locations

ENT department, Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Bianca MR Lorntzsen, MD

Role: CONTACT

b.m.lorntzsen@medisin.uio.no

+4790087002

Terje A Osnes, MD, PhD

Role: CONTACT

terje.osnes@medisin.uio.no

+4723071784

Facility Contacts

Bianca MR Lorntzsen, MD

Role: primary

b.m.lorntzsen@medisin.uio.no

+4790087002

Terje A Osnes, MD, PhD

Role: backup

terje.osnes@medisin.uio.no

+4723071784

Other Identifiers

2017/1040

Identifier Type: -

Identifier Source: org_study_id