Thyroid CancerNCT06269731
Anxiety & Depression in Thyroid Cancer Patients
An observational study of Thyroid Cancer, run by Assiut University.
Trial summary
1. To identify the prevalence of both anxiety and depression in thyroid cancer patients 2. To assess quality of life in thyroid cancer patients Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Hamilton depression Rating Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Adult, Older adult
Study population: thyroid cancer patients
Who may be able to join
- Age at or more than 18 years old
- None of the patients had history of other psychiatric illness
- Both sex
- Accept to participate in the study
Who cannot join
- Age less than 18 years old
- Previous history of other psychiatric illness
- substance abuser or dependence
- Refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anxiety, Depression and Quality of Life in Thyroid Cancer Patients
- To identify the prevalence of both anxiety and depression in thyroid cancer patients
- To assess quality of life in thyroid cancer patients
Read the detailed description
In recent years, increasing attention has been paid to mental health among cancer patients.
Thyroid cancer is one of the most frequent endocrine neoplasia. It consists of 4 subtypes of papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer, and anaplastic thyroid cancer.
Which is usually asymptomatic in the early stages, but symptoms such as neck pain, hoarseness, and dysphagia may occur as the disease progresses. TC is diagnosed by physical examination, analysis of thyroid hormone levels, imaging, and biopsy.
Anxiety and depression are the most common psychological problems in the treatment of cancer patients and are related to the majority of medical diseases and physical symptoms.
Studies have suggested that anxiety and depression are common in patients with thyroid cancer.
Therefore, quality of life which includes psychological, social, and spiritual well-being, has become an important consideration .
These findings highlight the importance of identifying thyroid cancer patients needs to allow better and more adequate care and support.
- Conditions
- Thyroid Cancer
- Being tested
- Hamilton depression Rating Scale
- Keywords
- depression, anxiety
- Medical subject headings
- Thyroid Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamilton depression Rating ScaleBehavioural
Also called Hamilton Anxiety Rating Scale, Quality of life Questionnaire, Symptom Checklist-90-Revised
also known as the Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. Although the scale was designed for completion after an unstructured clinical interview, The scale has been translated into a number of languages including French, German, Italian, Thai , Turkish and Arabic version by Mostafa Lotfy.
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of anxiety in thyroid cancer patients
To identify the prevalence of anxiety in thyroid cancer patients by using Hamilton Anxiety Rating Scale
Measured: baseline
the prevalence of depression in thyroid cancer patients
To identify the prevalence of depression in thyroid cancer patients by using Hamilton Depression Rating Scale
Measured: baseline
Secondary outcomes (1)
assess quality of life in thyroid cancer patients
Detect quality of life in patients with thyroid cancer by using Short form 36 Quality of life questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mamdouh Mohammed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269731
- Sponsor's protocol ID
- Thyroid cancer
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tagay S, Herpertz S, Langkafel M, Erim Y, Bockisch A, Senf W, Gorges R. Health-related Quality of Life, depression and anxiety in thyroid cancer patients. Qual Life Res. 2006 May;15(4):695-703. doi: 10.1007/s11136-005-3689-7.
PubMed 16688502Dionisi-Vici M, Fantoni M, Botto R, Nervo A, Felicetti F, Rossetto R, Gallo M, Arvat E, Torta R, Leombruni P. Distress, anxiety, depression and unmet needs in thyroid cancer survivors: a longitudinal study. Endocrine. 2021 Dec;74(3):603-610. doi: 10.1007/s12020-021-02786-y. Epub 2021 Jun 18.
PubMed 34143334Alexander K, Lee SC, Georgiades S, Constantinou C. The "not so good" thyroid cancer: a scoping review on risk factors associated with anxiety, depression and quality of life. J Med Life. 2023 Mar;16(3):348-371. doi: 10.25122/jml-2022-0204.
PubMed 37168306
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety, Depression and Quality of Life in Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT06269731
- Acronym / sponsor ID
- Thyroid cancer
- Conditions
- Thyroid Cancer
- Keywords
- depression, anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Feb 2024 (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.
- To identify the prevalence of both anxiety and depression in thyroid cancer patients
- To assess quality of life in thyroid cancer patients
Detailed description
In recent years, increasing attention has been paid to mental health among cancer patients.
Thyroid cancer is one of the most frequent endocrine neoplasia. It consists of 4 subtypes of papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer, and anaplastic thyroid cancer.
Which is usually asymptomatic in the early stages, but symptoms such as neck pain, hoarseness, and dysphagia may occur as the disease progresses. TC is diagnosed by physical examination, analysis of thyroid hormone levels, imaging, and biopsy.
Anxiety and depression are the most common psychological problems in the treatment of cancer patients and are related to the majority of medical diseases and physical symptoms.
Studies have suggested that anxiety and depression are common in patients with thyroid cancer.
Therefore, quality of life which includes psychological, social, and spiritual well-being, has become an important consideration .
These findings highlight the importance of identifying thyroid cancer patients needs to allow better and more adequate care and support.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- thyroid cancer patients
Key inclusion criteria (4 listed)
- Age at or more than 18 years old
- None of the patients had history of other psychiatric illness
- Both sex
- Accept to participate in the study
Key exclusion criteria (4 listed)
- Age less than 18 years old
- Previous history of other psychiatric illness
- substance abuser or dependence
- Refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamilton depression Rating ScaleAlso: Hamilton Anxiety Rating Scale, Quality of life Questionnaire, Symptom Checklist-90-Revisedalso known as the Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. Although the scale was designed for completion after an unstructured clinical interview, The scale has been translated into a number of languages including French, German, Italian, Thai , Turkish and Arabic version by Mostafa Lotfy. | Behavioural | – |
Primary outcome
the prevalence of anxiety in thyroid cancer patients
Time frame: baseline
To identify the prevalence of anxiety in thyroid cancer patients by using Hamilton Anxiety Rating Scale
the prevalence of depression in thyroid cancer patients
Time frame: baseline
To identify the prevalence of depression in thyroid cancer patients by using Hamilton Depression Rating Scale
1 secondary outcome
assess quality of life in thyroid cancer patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 16688502Tagay S, Herpertz S, Langkafel M, Erim Y, Bockisch A, Senf W, Gorges R. Health-related Quality of Life, depression and anxiety in thyroid cancer patients. Qual Life Res. 2006 May;15(4):695-703. doi: 10.1007/s11136-005-3689-7.
- Background: PubMed 34143334Dionisi-Vici M, Fantoni M, Botto R, Nervo A, Felicetti F, Rossetto R, Gallo M, Arvat E, Torta R, Leombruni P. Distress, anxiety, depression and unmet needs in thyroid cancer survivors: a longitudinal study. Endocrine. 2021 Dec;74(3):603-610. doi: 10.1007/s12020-021-02786-y. Epub 2021 Jun 18.
- Background: PubMed 37168306Alexander K, Lee SC, Georgiades S, Constantinou C. The "not so good" thyroid cancer: a scoping review on risk factors associated with anxiety, depression and quality of life. J Med Life. 2023 Mar;16(3):348-371. doi: 10.25122/jml-2022-0204.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salma mamdouh (+201016297915, salmamamdouhmm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of anxiety in thyroid cancer patients (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269731, which also lists 3 linked publications.
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 21 Feb 2024.