HRQOL in Thyroid Cancer and Thyroid Tumours

NCT03676348 | Recruiting

• 1 other identifier: 2017/1040
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule; Thyroid Cancer; Quality of Life

Keywords

quality of life; health related quality of life; thyroid cancer; thyroid nodule; thyroid neoplasm; thyroid surgery; patient reported outcome measurements

Outcome Measures

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.

  Circa 12 months from date of (last) thyroid surgery for the individual participant

Secondary Outcomes (3)

• Change in fatigue score

  Circa 12 months from date of (last) thyroid surgery for the individual participant

• Change in HRQOL before and after radioiodine treatment

  Circa 12 months from date of (last) thyroid surgery for the individual participant

• Change in HRQOL between participants With benign and malignant tumours

  Circa 12 months from date of (last) thyroid surgery for the individual participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

ENT department, Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Terje A Osnes, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca MR Lorntzsen, MD

CONTACT

+4790087002; b.m.lorntzsen@medisin.uio.no

Terje A Osnes, MD, PhD

CONTACT

+4723071784; terje.osnes@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD candidate

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: January 25, 2018
• Primary Completion: April 1, 2023
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)