Thyroid NoduleNCT03676348
HRQOL in Thyroid Cancer and Thyroid Tumours
An observational study of Thyroid Nodule and Thyroid Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer, Quality of Life
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 25 Jan 2018to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
ENT department, Oslo University Hospital
Oslo
Bianca MR Lorntzsen, MD, +4790087002, b.m.lorntzsen@medisin.uio.no
Terje A Osnes, MD, PhD, +4723071784, terje.osnes@medisin.uio.no
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Circa 12 months from date of (last) thyroid surgery for the individual participant
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Circa 12 months from date of (last) thyroid surgery for the individual participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start25 Jan 2018
- Primary completionApr 2023 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca M.R. Lorntzsen, Oslo University Hospital
- Investigators
- Terje A Osnes, MD, PhD, Principal investigator, Professor otorhinolaryngology, Rikshospitalet, Oslo University Hospital. Head of department, otorhinolaryngology - head and neck surgery, Rikshospitalet, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676348
- Sponsor's protocol ID
- 2017/1040
- Status last verified
- Feb 2022
- First submitted
- 17 Sep 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life in Thyroid Cancer Patients, and in Patients With Thyroid Nodules Suspicious of Cancer
- ClinicalTrials.gov ID
- NCT03676348
- Acronym / sponsor ID
- 2017/1040
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Change in fatigue score
Time frame: Circa 12 months from date of (last) thyroid surgery for the individual participant
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 between participants With benign and malignant tumours
Time frame: Circa 12 months from date of (last) thyroid surgery for the individual participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terje A Osnes, MD, PhD principal investigator
Professor otorhinolaryngology, Rikshospitalet, Oslo University Hospital. Head of department, otorhinolaryngology - head and neck surgery, Rikshospitalet, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule and Thyroid Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bianca MR Lorntzsen, MD (+4790087002, b.m.lorntzsen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global HRQOL score (time frame: Circa 12 months from date of (last) thyroid surgery for the individual participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.