NCT06422702Active, not recruiting
The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer
A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period
Source: ClinicalTrials.gov · Last updated 18 Feb 2025
Brief summary (registry, in English)
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. 1. 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. 2. 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 12 May 2024
- Start date
- 1 Aug 2023
- Primary completion date
- 22 Jan 2024
- Lead sponsor
- Harbin Medical University
- Diseases
- Thyroid cancer
- NCT number
- NCT06422702
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Aug 2023 to the primary completion date, 22 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients taking hypnotics or psychotropic medications
- have recently participated in a similar intervention or are receiving other psychotherapy
Other illness
- History of neck or shoulder trauma
- Coexisting serious heart, brain, or lung diseases
- History of a major psychological disorder or mental illness
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.