HRQOL in Thyroid Cancer and Thyroid Tumours

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03676348
Collaborator
(none)
200
1
122.2
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Health Related Quality of Life in Thyroid Cancer Patients, and in Patients With Thyroid Nodules Suspicious of Cancer
    Actual Study Start Date :
    Jan 25, 2018
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Change in global HRQOL score [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 Outcome Measures

    1. Change in fatigue score [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 [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 [Circa 12 months from date of (last) thyroid surgery for the individual participant]

      Change in HRQOL between participants With benign and malignant tumours.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ENT department, Oslo University Hospital Oslo Norway

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bianca M.R. Lorntzsen, MD, PhD candidate, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03676348
    Other Study ID Numbers:
    • 2017/1040
    First Posted:
    Sep 18, 2018
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bianca M.R. Lorntzsen, MD, PhD candidate, Oslo University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 11, 2022