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NCT Number: NCT03676348

HRQOL in Thyroid Cancer and Thyroid Tumours

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.

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Key information

Conditions

Thyroid Nodule Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Quality of Life Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in global HRQOL score

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

    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.

Secondary outcomes

  1. Change in fatigue score

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

    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.

  2. Change in HRQOL before and after radioiodine treatment

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

    Change in HRQOL before and after radioiodine treatment.

  3. Change in HRQOL between participants With benign and malignant tumours

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

    Change in HRQOL between participants With benign and malignant tumours.

Study contacts

Contact information is provided by the study sponsor or research team.

Bianca MR Lorntzsen, MD

CONTACT

[email protected]

+4790087002

Terje A Osnes, MD, PhD

CONTACT

[email protected]

+4723071784

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Sep 18, 2018
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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