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

NCT ID: NCT06422702

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-04-22

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

intervention group

A 12-week psychosomatic symptom intervention was conducted

Group Type: EXPERIMENTAL

Psychosomatic Symptoms Intervention

Intervention Type: OTHER

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

control group

Implementation of 12 weeks of continuous nursing (comfort attention)

Group Type: OTHER

Extended supportive care

Intervention Type: OTHER

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

Interventions

Psychosomatic Symptoms Intervention

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

Intervention Type: OTHER

Extended supportive care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shuhua Luo

researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harbin Medical University

Harbin, Heilongjiang, China

Countries

China

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

72004047

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JFCX202303

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

YJSCX2023-295HYD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HMUDQ20231116204

Identifier Type: -

Identifier Source: org_study_id