A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period
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
Sponsor: Harbin Medical University

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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Research Proposal
Title ：
To explore the effect of psychosomatic symptom intervention
program on patients with differentiated thyroid cancer during
the initial treatment period
Project Leader: Shu-hua Luo
Project Research Staff: Two Master’s of Nursing, one Registered Nurse,
one Head Nurse, one Clinician, and one Doctor of Nursing
The Organizer: Harbin Medical University
Date: May 1, 2023

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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To explore the effect of psychosomatic symptom intervention
program on patients with differentiated thyroid cancer during the
initial treatment period
I. Research background
Thyroid cancer is the most common malignant tumor of the endocrine system,
and differentiated thyroid cancer (DTC) accounts for more than 95% of thyroid
cancers. The initial treatment period usually refers to the first year after a patient has
received surgery, Thyroid stimulating hormone (TSH) suppression therapy, or
radioiodine therapy. During this stage, patients are usually in a period of thyroid
hormone disorder, which may have a variety of adverse effects. Studies have shown
that patients may experience a variety of health-related problems during this stage.
Most patients are not only prone to neck discomfort and pain after surgery, but also
may face the risk of physical complications such as postoperative bleeding, nerve
injury, hypoparathyroidism, and psychological problems such as anxiety, depression,
sleep disorders, and fear of recurrence. These psychosomatic symptoms will directly
or indirectly affect the patients’ TSH target rate. When patients have low stress coping
ability, poor self-management ability, and cannot adhere to long-term, scientific and
reasonable medication, the level of thyroid hormone in the blood will be affected,
which will lead to the reduction of treatment effect and quality of life, and the risk of
disease recurrence may also be increased. Therefore, this study intends to design a
psychosomatic symptom intervention program for patients with differentiated thyroid
cancer in the initial treatment period based on the experience of psychosomatic

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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symptoms of patients in the initial treatment period, aiming to improve the
physiological discomfort symptoms and negative psychological experience of patients
in the initial treatment period, enhance the patients' self-management efficacy, and
thus promote TSH suppression therapy to reach the target and physical and mental
health.
II、Study Protocol
1. Project basis
1.1 Research significance: Many scholars have studied postoperative DTC patients
and found that patients with this disease have serious psychosomatic symptoms. At
present, the intervention of postoperative psychosomatic symptoms of DTC patients
at home and abroad mainly focuses on psychological intervention. Few scholars pay
attention to the coordinated development of physical and psychological functions of
DTC patients in the initial treatment period, especially the dynamic assessment of
postoperative
TSH
level
and
the
management
of
drug-induced
symptoms.
Psychosomatic medicine believes that while taking into account the comprehensive
treatment of the disease, psychological intervention should also be used. The two
aspects should be coordinated to carry out effective psychological and physiological
intervention to maintain a good psychosomatic state of patients. In summary, this
study was guided by stress inoculation training. The three stages of stress inoculation
training
(conceptualization,
skill
acquisition
and
repetition,
application
and
completion) were used to simulate the different responses of patients under
psychosomatic stress, and the intervention steps were designed. Guided by the theory

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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of symptom management, the psychosomatic symptoms of DTC patients in the initial
treatment
period
were
divided
into
physiological
function
management
and
psychological function management, and intervention measures were formulated to
promote the synergistic effect of the positive development of the psychosomatic state
of patients, so as to provide reference for clinical practice.
1.2 Design idea:
（1）Through literature review, qualitative research, Delphi expert letter consultation
and
pre-experiment,
the
psychosomatic
symptom
intervention
program
was
constructed.
（2）A randomized controlled trial was conducted. The participants who met the
inclusion criteria were randomly divided into the intervention group and the control
group by block randomization method. The intervention group was intervened for
psychosomatic symptoms to verify the effectiveness of the intervention program.
2. The research content and objectives of the project were analyzed
2.1 Research Content
（1）In the early stage, literature review and qualitative research were conducted
to construct the psychosomatic symptoms intervention program. After that, the
intervention program was modified through Delphi expert consultation and
pre-experiment to form the final version of the intervention program.
（2）A randomized controlled trial was conducted to verify the effectiveness of
the intervention program. Patients with DTC at the initial treatment stage were
selected as the research objects, and the patients who met the inclusion criteria

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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were divided into the intervention group and the control group according to the
block randomization method. The control group carried out routine nursing
education + continuous support nursing, while the intervention group carried out
routine nursing education + continuous support nursing + psychosomatic
symptom intervention.
（3）The primary outcome indicator was TSH level, and the secondary outcome
indicators were anxiety, depression, self-management efficacy, and shoulder joint
function.
2.2 Research objectives
To verify the effectiveness of the psychosomatic symptom intervention program
in patients with newly treated differentiated thyroid cancer in improving postoperative
TSH, anxiety, depression, and self-management efficacy.
3. Proposed study protocol and feasibility analysis
3.1 Study Protocol:
3.1.1 Subjects: DTC patients who met the inclusion criteria in a cancer hospital
in Heilongjiang Province.
Inclusion criteria: ①Differentiated thyroid cancer confirmed by pathological
examination; ②Normal cognitive and language communication skills, with the
ability to read and understand Chinese questionnaires; ③able to use smart phones; ④
informed consent and voluntary participation in this study.
Exclusion criteria: ①previous history of neck and shoulder trauma (such as
shoulder pain, tendinitis, tendon rupture, scapulohumeral periarthritis, or neuropathy);
②patients with severe heart, brain, lung diseases and cognitive dysfunction; ③with

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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a history of serious mental illness or psychiatric disorders; ④patients taking sleep
medication or psychotherapeutic medication; And ⑤those who had recently
participated
in
similar
interventions
or
were
receiving
other
psychological
interventions.
3.1.2 Benefits: all participants were reimbursements for a five-test thyroid function
test and occasional small gifts.
3.1.3 Sample Size: PASS 15.0.5 software was used to calculate, Sample Size, Normal
Approximation, Two-Sized, Z-Test(Unpooled) was selected, the test energy efficiency
was set to 0.8, α was 0.05, N1=N2, and the effective rate of the intervention group was set
to 0.8. The effective rate of the intervention group was set to 0.8, and the control group
was set to 0.5, then the required sample size was 72 cases. Based on a 15% loss to
follow-up rate, the required sample size was 83. To facilitate the design of block
randomization in this study (1:1 group design), the block size was set to 4, so the sample
size was preferably even, so at least 84 samples were required.
3.1.4 Trial procedure
Grouping: Participants were selected from the Department of Thyroid Surgery of a
cancer hospital in Heilongjiang Province by convenience sampling method. Patients
who met the inclusion criteria were randomly divided into intervention group and control
group according to the type of surgery and BMI.
Routine nursing: 1) condition observation and vital signs monitoring; 2) Diet
nursing: fasting water on the day of the operation, a small amount of water after the
condition is stable, and the diet gradually changes from liquid to semi-liquid and soft
food; 3) Posture: when the patient's condition was stable, he was given a

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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semi-recubuted position, encouraged to move in bed, and protected the neck when
changing position. 4) Keep the neck drainage tube unobstructed, observe and record
the drainage fluid; 5) closely observe patients' swallowing, pronunciation, incision
and other conditions; 6) Prepare a tracheotomy kit beside the bed; 7) a unified health
education lecture was conducted before discharge, including drug knowledge and
review related precautions.
Control group: routine nursing + continuous support nursing. Contents of
continuing care: after discharge, patients were provided with care through the Internet
and wechat platform: ①establishing wechat group to answer patients' questions in
time; ②Patients described their own recovery and condition in the group at any time,
and the researchers regularly summarized the patient's condition data. ③Using
wechat public platform, push DTC disease management knowledge every week, such
as the cause of the disease, treatment progress, disease recurrence, scar and
postoperative home care tips.
Intervention
group:
routine
nursing
+
continuous
support
nursing
+
psychosomatic symptom intervention program. Psychosomatic symptom intervention
included three parts: psychological module, physiological module and psychosomatic
common module. The intervention program for psychosomatic symptoms was
constructed through literature review, semi-structured interview, Delphi expert
consultation and pre-test before the intervention, and the program was scientific and
feasible. Before the intervention, an expert group consisting of one oncology
expert, one psychological expert and one nursing expert was hired to train the

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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intervention of patients after thyroid cancer surgery. The training method was
on-site simulation teaching, and the training content included thyroid
cancer
related
knowledge,
psychological
related
knowledge,
related
intervention theories, methods and techniques used in this study. The
training
standards
required
that
the
intervention
participants
should
be
proficient in the knowledge of thyroid cancer and be able to use relevant
theories combined with psychological practice and specific functional training.
Finally, before the intervention, researchers wrote a manual for the intervention
of psychosomatic symptoms in patients with DTC at the initial treatment stage.
3.1.5 Outcome measures
Main outcome measures: thyroid stimulating hormone (TSH) control rate;
The
secondary
outcome
indicators
included
anxiety,
depression,
self-management efficacy and shoulder joint function.
3.2 Feasibility analysis
3.2.1 Preliminary Research Basis
This study was one of the sub-projects of "The psychosomatic mechanism and
hospital-community collaborative management and time effect of TSH suppression
treatment response in patients with postoperative differentiated thyroid cancer (DTC)"
funded by the National Natural Science Foundation of China Youth Project approved
in 2020.
3.2.2 Study conditions
The research site was a cancer hospital in Heilongjiang Province, which is a

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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third-grade class-A hospital. The thyroid surgery department has 106 standard beds
and performs more than 2600 thyroid surgeries every year, ranking in the forefront of
the same specialty in China. The research group has maintained a good cooperative
relationship with the hospital in the early stage, which can ensure the smooth progress
of the research.
3.2.3 Research Methods
The intervention program in this study was guided by stress inoculation training
and symptom management theory, and the content design was feasible. A randomized
controlled trial was used to intervene the psychosomatic symptoms of DTC patients in
the initial treatment period, and scientific and effective statistical analysis methods
were used to process and analyze the data, so as to increase the feasibility of the study
and the credibility of the research results.
3.2.4 Statistical methods to be adopted
SPSS 26.0 software was used for statistical analysis. The general data and
baseline characteristics were compared by independent sample t test and 2 test.
Shapiro-Wilk’s test was used to assess whether the data were normally distributed.
The continuous variables conforming to normal distribution were described by mean
± standard deviation, and the measurement data not conforming to normal distribution
were described by median and quartile. Two-factor repeated measures analysis of
variance or generalized estimating equation were used for comparison between
different groups at different time points. Main effect results were used when there was
no interaction, and the simple effect of one factor was analyzed when there was

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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interaction. Categorical variables were described by frequency and percentage, and
comparison between the two groups was2 performed by test. Multiple imputation
was used to account for missing data.
3.2.5 Acceptability of study subjects
Adhering to the principle of no harm and benefit, this study strives to improve
the mental and physical health of patients and the quality of life of patients through
the experiment, which is easy to be accepted by patients.
3.2.6 Research team
The research team of this study mainly included 1 master’s tutor, 2 nursing
master’s students, 1 nursing staff, 1 head nurse and a clinician. The main researchers
were two postgraduate students who had been fully trained in the early stage and were
assisted by professional medical staff. The medical staff could fully mobilize the
enthusiasm of the patients and cooperate with the researchers to complete the
experiment successfully, which could effectively carry out psychosomatic intervention
for the research objects.
In conclusion, the research protocol and technical route to be adopted in this
project are practical and feasible.

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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Signature page of informed consent form
Subject Statement
The investigator has explained to me in detail the purpose of the study, the
process, and the possible risks and benefits of participating in the study; I have
carefully read the informed consent form, all questions have been answered to my
satisfaction, and I fully understand it.
I consent to the collection and use of my health data by my researchers. I agree
that the research center will have access to my data and the results of this study for
scientific research purposes. I consent to the members of the Ethics Committee and
the representatives of the government authorities to have access to my data under the
principle of confidentiality. I understand that access to these records is necessary to
ensure that the data collected from this study is true, complete and reliable.
I understand that my participation in this study is voluntary, and I can withdraw from
the study at any time without affecting my subsequent legal rights and interests.
I have obtained a copy of my signed informed consent form. I did not give up any of
my legal rights when I signed this consent form.
Patient signing
Date
Tele
Signature of legal representative *
Date
Tele
Relationship with the patient
* The signature of a legal representative is not required unless the subject is

To explore the effect of psychosomatic symptom intervention program on patients with differentiated thyroid cancer during the initial treatment period
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unable to read (such as illiterate or blind) or cannot sign on his or her own for
some other reason.
Statement by the Investigator
I promise to strictly abide by the principles of GCP and the relevant regulations
of the state and the hospital in this study, to protect the rights and interests of the
subjects, and to ensure the authenticity, integrity and reliability of the research
working time and research data. I agree that the research group can access the data
and research results of this study for scientific research purposes.
I have fully explained the purpose of the study, the process, and the possible risks
and benefits of participation, and she has received sufficient information to make a
decision about participation in the study. I will provide the patient or his or her legal
representative with a signed and dated copy of the informed consent form.
Investigator signing
Date
Tele