Clinical trial NCT06422702: The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion criteria:

1. Clinical diagnosis of differentiated thyroid cancer
2. Participants had to be in the initial treatment phase
3. Cognitive and communication skills are normal
4. Can use a smartphone
5. Voluntary participation in the study

Exclusion criteria:

1. History of neck or shoulder trauma
2. Coexisting serious heart, brain, or lung diseases
3. History of a major psychological disorder or mental illness
4. Patients taking hypnotics or psychotropic medications
5. have recently participated in a similar intervention or are receiving other psychotherapy

Primary outcomes:
measure: anxiety and depression
timeFrame: 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:
measure: TSH
timeFrame: 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).
measure: Self-management efficacy
timeFrame: 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).
measure: Shoulder function
timeFrame: 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).
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University
state: Heilongjiang
Study officials:
References: