HRQOL in Thyroid Cancer and Thyroid Tumours

Health Related Quality of Life in Thyroid Cancer Patients, and in Patients With Thyroid Nodules Suspicious of Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Thyroid Cancer; Thyroid Nodule

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Bianca MR Lorntzsen, MD; Phone Number: +4790087002; Email: b.m.lorntzsen@medisin.uio.no
• Study Contact Backup: Name: Terje A Osnes, MD, PhD; Phone Number: +4723071784; Email: terje.osnes@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • ENT department, Oslo University Hospital
    • Contact: Bianca MR Lorntzsen, MD; Phone Number: +4790087002; Email: b.m.lorntzsen@medisin.uio.no
    • Contact: Terje A Osnes, MD, PhD; Phone Number: +4723071784; Email: terje.osnes@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Circa 12 months from date of (last) thyroid surgery for the individual participant
Change in HRQOL before and after radioiodine treatment	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	Change in HRQOL between participants With benign and malignant tumours.	Circa 12 months from date of (last) thyroid surgery for the individual participant

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Terje A Osnes, MD, PhD, Professor otorhinolaryngology, Rikshospitalet, Oslo University Hospital. Head of department, otorhinolaryngology - head and neck surgery, Rikshospitalet, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2028

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; thyroid cancer; health related quality of life; thyroid neoplasm; thyroid nodule; thyroid surgery; patient reported outcome measurements
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: 2017/1040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No