Pathologically Confirmed Differentiated Thyroid CarcinomaNCT06422702
The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer
A study testing Psychosomatic Symptoms Intervention and Extended supportive care in people with Pathologically Confirmed Differentiated Thyroid Carcinoma and All Patients Are in the Initial Treatment Phase, run by Harbin Medical University at 1 site in China.
Trial summary
The psychosomatic symptoms of patients with differentiated thyroid cancer (DTC) during the initial treatment phase need to be improved. Stress coping training aims to reshape an individual's perception of stress and provide skill training, thereby influencing how they cope in stressful situations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pathologically Confirmed Differentiated Thyroid Carcinoma, All Patients Are in the Initial Treatment Phase, Normal Cognitive and Communicative Abilities, Capable of Reading and Understanding Questionnaires in Chinese
- What is being tested?
- Psychosomatic Symptoms Intervention and Extended supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 22 Apr 2025
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of differentiated thyroid cancer
- Participants had to be in the initial treatment phase
- Cognitive and communication skills are normal
- Can use a smartphone
- Voluntary participation in the study
Who cannot join
- History of neck or shoulder trauma
- Coexisting serious heart, brain, or lung diseases
- History of a major psychological disorder or mental illness
- Patients taking hypnotics or psychotropic medications
- have recently participated in a similar intervention or are receiving other psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period
The psychosomatic symptoms of patients with differentiated thyroid cancer (DTC) during the initial treatment phase need to be improved. Stress coping training aims to reshape an individual's perception of stress and provide skill training, thereby influencing how they cope in stressful situations. Symptom management theory emphasizes improving health outcomes by helping individuals perceive and manage their symptoms.
Therefore, this clinical trial combines stress coping training and symptom management theory to construct and test an intervention program for psychosomatic symptoms in DTC patients. The main questions it aims to answer are:
Read more
- Does the psychosomatic symptom intervention alleviate participants' levels of anxiety and depression?
- Does the psychosomatic symptom intervention promote participants' achievement of TSH suppression therapy standards?
- Does the psychosomatic symptom intervention enhance participants' self-management efficacy?
- Does the psychosomatic symptom intervention improve participants' shoulder joint function?
Researchers will compare the psychosomatic symptom intervention with continuous psychological care (a form of comforting care) to determine if the intervention better promotes participants' psychosomatic health.
- Before conducting this clinical trial, researchers conducted qualitative interviews with DTC patients and healthcare providers, followed by literature analysis and expert consultations to develop a psychosomatic symptom intervention program for DTC patients during the initial treatment phase.
- A total of 84 DTC patients in the initial treatment phase were recruited and randomly grouped into two blocks. The intervention group received a 12-week psychosomatic symptom intervention in addition to routine care, while the control group received 12 weeks of continuous care. Data were collected before the intervention, at the end of the intervention, 3 months after the intervention, and 6 months after the intervention.
The psychosomatic symptom intervention mainly includes:
- Psychological module: symptom logs, meditation, positive psychology, and emotional management
- Physiological module: gargling exercises, "T" exercises, "米" exercises, and shoulder-neck exercises
- The psychosomatic module aims to intervene at three levels: individual, environmental, and health and disease. The individual level includes role management and self-awareness. The environmental level includes resource utilization, family support, peer support, and social support. The health and disease level includes disease management, individual counseling, and progressive muscle relaxation training.
- The intervention is divided into three stages: concept formation, skill acquisition and repetition, and application and completion. These stages are further divided into six sub-stages, each containing content from the psychological, physiological, and psychosomatic modules.
- Conditions
- Pathologically Confirmed Differentiated Thyroid Carcinoma, All Patients Are in the Initial Treatment Phase, Normal Cognitive and Communicative Abilities, Capable of Reading and Understanding Questionnaires in Chinese, Ability to Use a Smartphone, Voluntary Participation in the Study and Signed Informed Consent
- Being tested
- Psychosomatic Symptoms Intervention, Extended supportive care
- Keywords
- Differentiated thyroid cancer, Anxiety, Depression, Thyroid stimulating hormone, Randomized block design
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosomatic Symptoms InterventionOther
Psychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms.
Extended supportive careOther
The control group implemented continuity of supportive care based on primary care
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | A 12-week psychosomatic symptom intervention was conducted Receives: Other: Psychosomatic Symptoms Intervention |
| control group | Other | Implementation of 12 weeks of continuous nursing (comfort attention) Receives: Other: Extended supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression levels of DTC patients. The scale was developed by Zigmond in 1983 and is primarily used to assess the anxiety and depression of the subjects over the past month. A total of 14 items were included, comprising an anxiety subscale and a depression subscale, each containing 7 items. According to the frequency of occurrence, the situation is divided into four levels, namely "1 to 4", scored from 0 to 3 points, and the two subscales range from 0 to 21 points. The lowest possible score is 0, while the highest is 42. Higher scores on the scale indicate more severe levels of anxiety and depression.
Measured: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).
Secondary outcomes (3)
TSH
This study is based on the recommended by 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. First, in patients with a structural incomplete response to therapy, the serum TSH should be maintained below 0.1 mU/L. Secondly, in patients with a biochemical incomplete response to therapy, the serum TSH should be maintained between 0.1 and 0.5 mU/L. In patients with an excellent (clinically and biochemically free of disease) or indeterminate response to therapy, the serum TSH may be kept within the low reference range (0.5-2 mU/L). Finally, in patients who have not undergone remnant ablation, the serum TSH can be allowed to rise to the low reference range (0.5-2 mU/L).
Measured: Before the start of the intervention (T0), at the end of the intervention (up to 12 weeks of intervention, i.e., three months postoperatively, T1), and six months after the end of the intervention (i.e., nine months postoperatively, T2).
Self-management efficacy
The Chinese version of Strategies Used by People to Promote Health (C-SUPPH) was used to evaluate the self-management efficacy of DTC patients. The scale was developed in 1996, and the Chinese version was revised by Huijuan Qian et al. There were 28 items in total, including 3 dimensions of positive attitude (items 7, 15 to 28), self-decision-making (items 10 to 12) and self-decompression (items 1 to 6, 8, 14). Each item was scored using the Likert 5 scale, with a score of 1 indicating no confidence and a score of 5 indicating very confident. The total score ranged from 28 to 140, ranging from 0 to 55 (low level), from 55 to 112 (medium level), and from >112 (high level), with higher scores indicating greater confidence in the individual to perform self-care.
Measured: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).
Shoulder function
The Constant-Murley Shoulder Function Scale (CMS) was used to assess the shoulder joint activity of the two groups. The scale includes two dimensions: subjective evaluation and objective evaluation. Subjective evaluation included pain levels and activities of daily living. Objective evaluation included assessing shoulder range of motion and muscle strength. The lowest score is 0, the highest score is 100, higher scores indicate better shoulder function.
Measured: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Aug 2023
- Primary completion22 Jan 2024
- Study completion22 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologically Confirmed Differentiated Thyroid CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuhua Luo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422702
- Sponsor's protocol ID
- HMUDQ20231116204
- Other IDs
- 72004047, JFCX202303, YJSCX2023-295HYD
- Status last verified
- Feb 2025
- First submitted
- 12 May 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period
- ClinicalTrials.gov ID
- NCT06422702
- Acronym / sponsor ID
- HMUDQ20231116204
- Conditions
- Pathologically Confirmed Differentiated Thyroid Carcinoma, All Patients Are in the Initial Treatment Phase, Normal Cognitive and Communicative Abilities, Capable of Reading and Understanding Questionnaires in Chinese, Ability to Use a Smartphone, Voluntary Participation in the Study and Signed Informed Consent
- Keywords
- Differentiated thyroid cancer, Anxiety, Depression, Thyroid stimulating hormone, Randomized block design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Apr 2025 (estimated)
- First posted
- 21 May 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.
The psychosomatic symptoms of patients with differentiated thyroid cancer (DTC) during the initial treatment phase need to be improved. Stress coping training aims to reshape an individual's perception of stress and provide skill training, thereby influencing how they cope in stressful situations. Symptom management theory emphasizes improving health outcomes by helping individuals perceive and manage their symptoms.
Therefore, this clinical trial combines stress coping training and symptom management theory to construct and test an intervention program for psychosomatic symptoms in DTC patients. The main questions it aims to answer are:
- Does the psychosomatic symptom intervention alleviate participants' levels of anxiety and depression?
- Does the psychosomatic symptom intervention promote participants' achievement of TSH suppression therapy standards?
- Does the psychosomatic symptom intervention enhance participants' self-management efficacy?
- Does the psychosomatic symptom intervention improve participants' shoulder joint function?
Researchers will compare the psychosomatic symptom intervention with continuous psychological care (a form of comforting care) to determine if the intervention better promotes participants' psychosomatic health.
- Before conducting this clinical trial, researchers conducted qualitative interviews with DTC patients and healthcare providers, followed by literature analysis and expert consultations to develop a psychosomatic symptom intervention program for DTC patients during the initial treatment phase.
- A total of 84 DTC patients in the initial treatment phase were recruited and randomly grouped into two blocks. The intervention group received a 12-week psychosomatic symptom intervention in addition to routine care, while the control group received 12 weeks of continuous care. Data were collected before the intervention, at the end of the intervention, 3 months after the intervention, and 6 months after the intervention.
The psychosomatic symptom intervention mainly includes:
- Psychological module: symptom logs, meditation, positive psychology, and emotional management
- Physiological module: gargling exercises, "T" exercises, "米" exercises, and shoulder-neck exercises
- The psychosomatic module aims to intervene at three levels: individual, environmental, and health and disease. The individual level includes role management and self-awareness. The environmental level includes resource utilization, family support, peer support, and social support. The health and disease level includes disease management, individual counseling, and progressive muscle relaxation training.
- The intervention is divided into three stages: concept formation, skill acquisition and repetition, and application and completion. These stages are further divided into six sub-stages, each containing content from the psychological, physiological, and psychosomatic modules.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Psychosomatic Symptoms InterventionA 12-week psychosomatic symptom intervention was conducted |
| control group | Other | Other: Extended supportive careImplementation of 12 weeks of continuous nursing (comfort attention) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of differentiated thyroid cancer
- Participants had to be in the initial treatment phase
- Cognitive and communication skills are normal
- Can use a smartphone
- Voluntary participation in the study
Key exclusion criteria (5 listed)
- History of neck or shoulder trauma
- Coexisting serious heart, brain, or lung diseases
- History of a major psychological disorder or mental illness
- Patients taking hypnotics or psychotropic medications
- have recently participated in a similar intervention or are receiving other psychotherapy
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 |
|---|---|---|
| Psychosomatic Symptoms InterventionPsychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms. | Other | intervention group |
| Extended supportive careThe control group implemented continuity of supportive care based on primary care | Other | control group |
Primary outcome
anxiety and depression
Time frame: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).
The Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression levels of DTC patients. The scale was developed by Zigmond in 1983 and is primarily used to assess the anxiety and depression of the subjects over the past month. A total of 14 items were included, comprising an anxiety subscale and a depression subscale, each containing 7 items. According to the frequency of occurrence, the situation is divided into four levels, namely "1 to 4", scored from 0 to 3 points, and the two subscales range from 0 to 21 points. The lowest possible score is 0, while the highest is 42. Higher scores on the scale indicate more severe levels of anxiety and depression.
3 secondary outcomes
TSH
Time frame: Before the start of the intervention (T0), at the end of the intervention (up to 12 weeks of intervention, i.e., three months postoperatively, T1), and six months after the end of the intervention (i.e., nine months postoperatively, T2).
Self-management efficacy
Time frame: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).
Shoulder function
Time frame: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).
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 18 Feb 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosomatic Symptoms Intervention and Extended supportive care in people with Pathologically Confirmed Differentiated Thyroid Carcinoma and All Patients Are in the Initial Treatment Phase, run by Harbin Medical University at 1 site in China.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety and depression (time frame: Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3).). 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 18 Feb 2025.