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HRQOL in Thyroid Cancer and Thyroid Tumours

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ClinicalTrials.gov Identifier: NCT03676348
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bianca M.R. Lorntzsen, Oslo University Hospital

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
Thyroid Nodule Thyroid Cancer Quality of Life

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. The global score on EORTC QLQ C30 in the general population had shown to be 78.0. The primary endpoint is a difference in quality of life (defined as global score) before and after surgery of more than 10%. Assuming an alpha of 5% , a Power of 80% and a standard error of the difference of 15, the number of 32 participants in each subgroup is needed. To compensate for dropouts, an additional 10% had to be included, i.e. 71 participants.

Intraobserver analysis of plotting and calculations is planned.


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Study Type : Observational
Estimated Enrollment : 71 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 : January 25, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676348


Contacts
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Contact: Bianca MR Lorntzsen, MD +4790087002 b.m.lorntzsen@medisin.uio.no
Contact: Terje A Osnes, MD, PhD +4723071784 terje.osnes@medisin.uio.no

Locations
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Norway
ENT department, Oslo University Hospital Recruiting
Oslo, Norway
Contact: Bianca MR Lorntzsen, MD    +4790087002    b.m.lorntzsen@medisin.uio.no   
Contact: Terje A Osnes, MD, PhD    +4723071784    terje.osnes@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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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

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Responsible Party: Bianca M.R. Lorntzsen, MD, PhD candidate, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03676348     History of Changes
Other Study ID Numbers: 2017/1040
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Oslo University Hospital:
quality of life
health related quality of life
thyroid cancer
thyroid nodule
thyroid neoplasm
thyroid surgery
patient reported outcome measurements

Additional relevant MeSH terms:
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Thyroid Diseases
Thyroid Neoplasms
Thyroid Nodule
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms