A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- anxiety and depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
anxiety and depression
时间窗: 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.
次要结局
- TSH(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(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(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).)
研究者
Shuhua Luo
researcher
Harbin Medical University