The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer

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.

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

Interventions

OTHER

Psychosomatic Symptoms Intervention

Psychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms.

OTHER

Extended supportive care

The control group implemented continuity of supportive care based on primary care

Sponsors & Collaborators

• Harbin Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2024-01-22

Completion

2025-04-22

Countries

• China

Study Locations