Effect of cognitive behavior therapy based on the health education pathway on psychology of Chinese papillary thyroid carcinoma patients: A randomized controlled trial

doi:10.21203/rs.3.rs-1346761/v1

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Effect of cognitive behavior therapy based on the health education pathway on psychology of Chinese papillary thyroid carcinoma patients: A randomized controlled trial

https://doi.org/10.21203/rs.3.rs-1346761/v1

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Purpose: Our main aim was to explore whether cognitive behavior therapy based on the health education pathway (CBT-HEP) can effectively alleviate the psychological problems of papillary thyroid carcinoma (PTC) patients after ¹³¹I treatment.

Methods: Eligible PTC patients were prospectively included (July 1, 2019-February 1, 2021). The baseline demographic characteristics questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), the Distress Thermometer (DT), the Hamilton Anxiety Scale (HAMA), and the Patient Health Questionnaire-9 (PHQ-9)needed to be completed. Patients with a DT score ≥ 4 were randomly enrolled in further intervention trials. Patients received CBT-HEP and casual conversation (CC) in different groups.

Results: A total of 357 PTC patients were investigated in this study, 48 and 49 patients were included in the CBT-HEP and CC groups, respectively. The DT, HAMA, and PHQ-9 scores before and after intervention and after six months of follow-up were 5.19, 10.29, 5.60; 2.50, 5.44, 3.38; 1.67, 3.98, 2.79 (CBT-HEP) and 4.84, 8.16, 3.76; 4.39, 8.53, 4.63; 3.63, 8.14, 4.37 (CC), respectively. DT, HAMA, and PHQ-9 scores decreased more significantly in the CBT-HEP group. Women, living alone, hypothyroidism, sadness, anxiety, tingling in hands/feet, breathing, concern about the treatment effect and radiation safety significantly increased the likelihood of a severe DT score.

Conclusion: CBT-HEP is effective in relieving distress, anxiety and depression in PTC patients. In addition, PTC patients with the above characteristics have a poorer quality of life and should receive more attention.

Registration: ChiCTR1900025852; registration date, September 11, 2019

anxiety

cognitive behavior therapy

distress

depression

papillary thyroid carcinoma

quality of life

At present, research on patients' mental health and quality of life is an important aspect of cancer research [1]. The quality of life of most cancer patients is significantly lower than that of normal people and includes cognitive impairment, peripheral neuropathy, fatigue, depression, anxiety, and interpersonal disorders [2, 3]. Thyroid cancer is a very common tumor worldwide and characterized by high incidence but low mortality rate and good prognosis [4–6]. Surgical resection, thyroid stimulating hormone suppression therapy, and ¹³¹I radiation therapy are the major treatment modalities for thyroid cancer [7]. Surgery and medications in most patients are widely understood and accepted, but ¹³¹I treatment is not well understood [8], so patients may develop fears and concerns. However, a large number of medical professionals have neglected to care for the mental health of thyroid cancer patients in actual treatment because thyroid cancer has a good prognosis with a 5-year survival rate of over 98% [6].

The distress of thyroid cancer patients has been found to be comparable to that of other cancer patients with poor prognosis, and radiation therapy experience can significantly increase the distress of thyroid cancer patients [9]. In addition, patients with thyroid cancer were found to lack knowledge about ¹³¹I treatment and eager to obtain more relevant information [8]. At the same time, another study [10] also confirmed that more comprehensive information and correct understanding of the disease were important ways to alleviate the psychological distress of patients with thyroid cancer. Currently, studies have found that measures that can effectively alleviate depression, anxiety, and improve the quality of life of thyroid cancer patients are mainly psychological interventions, including psychological and behavioral interventions [11], mindfulness-based stress reduction [12] and psychological nursing intervention [13, 14]. There are few studies that combine knowledge dissemination with psychological interventions to alleviate psychological problems and improve quality of life in thyroid cancer patients.

In China, per capita income is now higher than before, and people have higher demands for their quality of life. However, the low level of education in thyroid cancer patients results in their inability to proactively reduce worries by obtaining the right information about the disease and ¹³¹I treatment. In addition, with the current three-child policy in China [15], more female patients of childbearing age are bound to worry about the impact of disease or ¹³¹I treatment on their fertility. Furthermore, although China's health care system has been improving, the severe lack of nursing staff is a real and serious problem compared to some developed countries [16]. How to use the limited medical resources in China to help thyroid cancer patients improve their quality of life is a problem that needs our attention and solution. Therefore, we created a new intervention called cognitive behavior therapy based on the health education pathway (CBT-HEP), in conjunction with the current reality of the Chinese health care system.

The purpose of this study was to explore whether CBT-HEP can effectively alleviate the distress, anxiety, and depression of papillary thyroid carcinoma (PTC) patients in China after ¹³¹I treatment. In addition, we investigated the critical factors that can significantly affect the distress and quality of life in PTC patients before ¹³¹I treatment.

Study design

This study was a prospective, single-center, randomized, and double-blinded clinical research. PTC patients intending to receive ¹³¹I therapy from July 1, 2019, to February 1, 2021, in the Department of Nuclear Medicine, West China Hospital, Sichuan University were recruited. The department implemented batch admission for ¹³¹I treatment of patients with PTC, so each batch of patients was admitted and discharged on the same day. We numbered the batches of patients during the planned period of this study in sequence, and randomly divided them by computer into the experimental group and the control group. Patients who were admitted to the corresponding batches and met the inclusion criteria were recruited into the experimental group or the control group respectively.

All patients completed the first-time questionnaires on the night of admission, including the basic demographic information questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Distress Thermometer (DT) and a list of questions. Patients with a DT score ≥ 4 were included in further intervention experiments and completed the Hamilton Anxiety Scale (HAMA) and Patient Health Questionnaire-9 (PHQ-9). On the second night of admission, the patients in the experimental group received CBT-HEP intervention, while the patients in the control group only underwent casual conversation (CC). After the intervention (the night before discharge), all participants included in the intervention experiment needed to complete the second-time DT, HAMA and PHQ-9 scales. Six months after discharge, the participants were required to fill out the third DT, HAMA and PHQ-9 scales by telephone as a follow-up survey (Fig. 1). All admitted patients received collective routine education from the nurses before ¹³¹I treatment, which mainly included daily arrangements, hospital and departmental rules and regulations, and answering patients' questions, etc. Our intervention was an additional component of routine education.

Recruitment

Inclusion criteria: 1. pathologically diagnosed with PTC, 2. total thyroidectomy had been performed, 3. admitted to the Department of Nuclear Medicine, West China Hospital of Sichuan University, and planned to conduct ¹³¹I therapy, 4. 18 years of age or older, with basic comprehension skills, able to write or answer questions verbally, and 5. agreed to participate in this experiment and sign the informed consent form.

Exclusion criteria: 1. suffered from a mental illness diagnosed by a specialist, and had been or was currently using related psychotropic drugs, 2. suffered from a neurological disease, or any disease that may affect the results of these questionnaires, including stroke, epilepsy, dementia, other tumors, brain surgery, head injury or severe concussion, 3. low intelligence, impaired understanding, unable to understand and answer these questionnaires after being explained by the researcher, 4. refused to participate in this study.

Interventions

CBT-HEP. Patients in the experimental group received CBT-HEP intervention after admission. The implementer of psychological intervention in this study had received professional operational training from a psychologist. The intervention was performed on the second night after the patient's admission (before ¹³¹I therapy) and did not interfere with the patient's daily examinations and treatments. (Supplementary Information S1).

CC. Researchers only had casual conversations with patients in the control group. The entire chat was purposeless, and the process was unstructured. Researchers can answer questions raised by patients, but cannot deliberately induce patients to change their own thinking.

Data collection and outcome measures

All questionnaires were completed in paper form, and one researcher assisted and supervised the patients in completing the questionnaires. The researcher was unclear about the grouping of patients, he could answer the patient's questions but could not interfere with the patient's questionnaire results. Primary outcomes included DT, HAMA, and PHQ-9. Secondary outcomes included baseline demographic characteristics, EORTC QLQ-C30, and questions list of DT.

The DT was scored visually on a scale ranging from 0–10. The clinical practice guidelines of the National Comprehensive Cancer Network (NCCN) for distress in cancer patients specified a cutoff point of 4 [17]; a DT score of ≥ 4 indicated severe distress, and < 4 indicated less severe distress. We added five special questions based on the characteristics of thyroid cancer disease itself and the ¹³¹I treatment (Supplementary Information S2). The HAMA is one of the common scales used by psychiatry to assess anxiety and contains 14 items, with higher scores indicating more anxiety [18]. The PHQ-9 is one of the simple and efficient scales to clinically screen for depression and contains a total of nine items, with higher scores indicating more depression [19].

The EORTC QLQ-C30 is a core scale for all cancer patients with 30 items that can be divided into 15 domains containing six single items, five functional domains, one overall health status and three symptom domains. Higher scores in the functional domains and overall health and lower scores in the symptom domains and single items indicated better quality of life [20]. The baseline demographic characteristics included gender, age, marital status, and education level. See Table 1 for details.

Table 1

Baseline characteristics
	Total (n = 357)	CBT-HEP (n = 48)	CC (n = 49)
Female, n (%)	275 (77.03)	44 (91.67)	41 (83.67)
Age, mean ± SD	38.83 ± 11.56	38.69 ± 9.55	38.35 ± 10.20
Nationality Minority, n (%) Han, n (%)	18 (5.04) 339 (94.96)	0 (0) 48 (100)	3 (6.12) 46 (93.88)
Living status Alone, n (%) Together, n (%)	41 (11.48) 316 (88.52)	9 (18.75) 39 (81.25)	8 (16.33) 41 (83.67)
Education ≤ 12 school years, n (%) > 12 school years, n (%)	198 (55.46) 159 (44.54)	33 (68.75) 15 (31.25)	29 (59.18) 20 (40.82)
Medical insurance No, n (%) Yes, n (%)	3 (0.84) 354 (99.16)	0 (0) 48 (100)	1 (2.04) 48 (97.96)
Occupation Not related to medicine or unemployed, n (%) Related to medicine, n (%)	338 (94.68) 19 (5.32)	48 (100) 0 (0)	48 (97.96) 1 (2.04)
Marriage Status Unmarried, n (%) Married, n (%)	55 (15.41) 302 (84.59)	5 (10.42) 43 (89.58)	6 (12.24) 43 (87.76)
Current smokers Yes, n (%) No, n (%)	17 (4.76) 340 (95.24)	1 (2.08) 47 (97.92)	3 (6.12) 46 (93.88)
Current drinkers Yes, n (%) No, n (%)	43 (12.04) 314 (87.96)	1 (2.08) 47 (97.92)	7 (14.29) 42 (85.71)
TNM I stage, n (%) II stage, n (%) III stage, n (%) IV stage, n (%)	310 (86.83) 34 (9.52) 11 (3.08) 2 (0.56)	42 (87.5) 6 (12.5) 0 (0) 0 (0)	45 (91.84) 0 (0) 4 (8.16) 0 (0)
Time since diagnosis ≤ 6 months, n (%) > 6 months, n (%)	292 (81.79) 65 (18.21)	41 (85.42) 7 (14.58)	39 (79.59) 10 (20.41)
Number of previous ¹³¹I < 1, n (%) ≥ 1, n (%)	332 (93.00) 25 (7.00)	45 (93.75) 3 (6.25)	47 (95.92) 2 (4.08)
Hypothyroidism symptoms Yes, n (%) No, n (%)	202 (56.58) 155 (43.42)	38 (79.17) 10 (20.83)	28 (57.14) 21 (42.86)
Hoarseness Yes, n (%) No, n (%)	102 (28.57) 255 (71.43)	17 (35.42) 31 (64.58)	12 (24.49) 37 (75.51)
Abbreviations: CBT-HEP = Cognitive Behavior Therapy based on Health Education Pathway; CC = Casual Conversation; TNM = Tumor, Node, Metastasis.

Statistical analysis

SPSS software (version 22) was used for statistical analysis. Paired t-test and two-independent samples t-test were used to analyze the differences within and between groups, respectively. The K-S test was used to verify the distribution of positivity of the data, and if the data did not conform to the positivity distribution, the Mann–Whitney U test was used instead of the two-independent samples t-test. The chi-square test was used as a second analysis method to analyze the remission rates of different scales. The chi-square test, Spearman rank correlation test, binary logistic regression, and multiple linear regression analysis by the stepwise regression method were used in the analysis of key factors affecting DT and quality of life. In all analyses, two-sided p values < 0.05 were considered statistically significant.

Study participants

During the experimental period from July 1, 2019, to February 1, 2021, a total of 357 PTC patients were surveyed (Fig. 1), with an average age of 38.83 years, of whom 275 were female (275/357, 77.0%). Table 1 shows the baseline demographic characteristics of all participants. A total of 103 people according to the inclusion criteria were included in the randomized controlled intervention experiment. Excluding the lost data after follow-up, 48 patients with complete data were enrolled in the final CBT-HEP group, and 49 patients were enrolled in the CC group (Fig. 1, Table 1).

Primary outcomes

The statistical results showed that among the DT scores of the CBT-HEP group before and after the intervention and after half a year of follow-up, there were statistically significant differences (p = 0.000, p = 0.000, p = 0.000). The scores of the HAMA scale in the CBT-HEP group at the above three time points were also significant differences (p = 0.000, p = 0.018, p = 0.000). The scores of the PHQ-9 scale in the CBT-HEP group at the above three time points were 5.60, 3.38 and 2.79, and there were statistically significant differences between the results (p = 0.000, p = 0.000), except for no significant differences between the post-intervention and follow-up results (p = 0.217) (Table 2).

Table 2

Comparison of DT, HAMA and PHQ-9 results at different time points
	CBT-HEP (n = 48)			CC (n = 49)			p (CBT-HEP versus CC)
	T1 Mean ± SD	T2 Mean ± SD	T3 Mean ± SD	T1 Mean ± SD	T2 Mean ± SD	T3 Mean ± SD	T1	T2	T3
DT	5.19 ± 1.38	2.50 ± 1.54	1.67 ± 1.29	4.84 ± 1.05	4.39 ± 1.12	3.63 ± 2.09	0.254	0.000	0.000
p_(1−2), p_(2−3), p₍₁₋₃₎ (95% CI)	0.000 (2.26 to 3.11)	0.000 (0.46 to 1.21)	0.000 (3.08 to 3.96)	0.003 (0.16 to 0.74)	0.022 (0.11 to 1.40)	0.000 (0.59 to 1.82)
HAMA	10.29 ± 6.59	5.44 ± 5.66	3.98 ± 3.58	8.16 ± 6.99	8.53 ± 6.06	8.14 ± 7.44	0.028	0.000	0.002
p_(1−2), p_(2−3), p₍₁₋₃₎ (95% CI)	0.000 (3.78 to 5.93)	0.018 (0.26 to 2.66)	0.000 (5.02 to 7.60)	0.532 (-1.54 to 0.81)	0.579 (-1.01 to 1.78)	0.981 (-1.69 to 1.73)
PHQ-9	5.60 ± 4.23	3.38 ± 3.35	2.79 ± 2.84	3.76 ± 3.43	4.63 ± 3.35	4.37 ± 3.54	0.021	0.003	0.011
p_(1−2), p_(2−3), p₍₁₋₃₎ (95% CI)	0.000 (1.19 to 3.27)	0.217 (-0.35 to 1.52)	0.000 (1.80 to 3.83)	0.043 (-1.73 to -0.03)	0.551 (-0.62 to 1.15)	0.164 (-1.48 to 0.26)
DT remission rate		79.2% (38/48)	91.7% (44/48)		16.3% (8/49)	44.9% (22/49)		0.000	0.000
HAMA remission rate		81.25% (39/48)	83.33% (40/48)		53.06% (26/49)	59.18% (29/49)		0.003	0.009
PHQ-9 remission rate		75% (36/48)	79.2% (38/48)		59.2% (29/49)	63.3% (31/49)		0.098	0.084
Notes: T1, assessment before the intervention and before ¹³¹I treatment; T2, assessment after the intervention, after ¹³¹I treatment and before discharge; T3, assessment after 6 months of follow-up. The analysis method within the group adopts the paired-T test, and the analysis method between the two groups adopts the Mann-Whitney U test, the chi-square test is used to analyze the difference in remission rate between groups.
Abbreviations: DT = Distress Thermometer; HAMA = Hamilton Anxiety Scale; PHQ-9 = Patient Health Questionnaire-9; CBT-HEP = Cognitive Behavior Therapy based on Health Education Pathway; CC = Casual Conversation.

The paired t-test showed that statistically significant differences could be seen (p = 0.003, p = 0.022, p = 0.000) among the DT scores of the CC group before and after the intervention, and after six months of follow-up. However, significant differences could not be seen among the scores of the HAMA scale in the CC group at the above three time points (p = 0.532, p = 0.579, p = 0.981). Then only the scores of the PHQ-9 scale in the CC group at before and after the intervention were significantly different (p = 0.043), while the rest of the results were not significantly different from each other (p = 0.551, p = 0.164) (Table 2).

The Mann–Whitney U test showed that there was no significant difference (p = 0.254) between the DT scores of the CBT-HEP and CC groups before the intervention, and significant differences between the scores of the two groups after the intervention and after the six-month follow-up could be seen (p = 0.000, p = 0.000). The comparisons of HAMA scores between the two groups were significantly different at the above three time points (p = 0.028, p = 0.000, p = 0.002). Statistically significant differences between the PHQ-9 scores of the two groups at the three time points could also be seen (p = 0.021, p = 0.003, p = 0.011) (Table 2).

A chi-square test was used to verify the above results, defining a DT score of less than 4 as distress relief [17]. DT remission rates in the CBT-HEP and CC groups at post-intervention and six-month follow-up were 79.2%, 16.3% and 91.7%, 44.9% respectively, with significant differences seen between the two groups (p = 0.000, p = 0.000). In addition, a HAMA score less than or equal to 7 was defined as anxiety remission [21, 22]. The anxiety remission rates in the two groups at the above two time points were 81.25%, 53.06% and 83.33%, 59.18% respectively, and significant differences were observed between the two groups (p = 0.003, p = 0.009). Moreover, a PHQ-9 score of less than 5 was defined as depression remission [23]. After the intervention and half-year follow-up, the depression relief rates of the two groups were 75%, 59.2% and 79.2%, 63.3%, respectively, and there were no significant differences between the above results (p = 0.098, p = 0.084) (Table 2).

Secondary outcomes

The variables that can significantly affect DT scores in the baseline demographic characteristics were female sex (p = 0.001, OR = 2.83), living alone, (p = 0.024, OR = 0.45) and hypothyroidism (p = 0.024, OR = 0.58) (Table 3, Supplementary Information S3). In the list of questions, sadness (p = 0.029, OR = 2.27), anxiety (p = 0.022, OR = 2.20), tingling in hands/feet (p = 0.004, OR = 2.52), breathing (p = 0.022, OR = 2.95), concern about the effectiveness of the treatment (p = 0.005, OR = 2.54), and concern about radiation safety (p = 0.024, OR = 1.98) would lead to an increased probability of a severe DT score (Table 3).

Table 3

Critical factors affecting DT score in baseline demographic characteristics and list of problems
	Chi-square test		Binary logistic regression analysis
	Pearson chi-square	p value	p value	Exp (B)	95% CI
Baseline demographic characteristics
Gender	11.01	0.001	0.001	2.83	1.50 to 5.33
Living status	3.87	0.049	0.024	0.45	0.23 to 0.90
hypothyroidism	6.03	0.014	0.024	0.58	0.36 to 0.93
List of problems
Work/school	4.79	0.029	0.052	1.97	1.00 to 3.90
Treatment decisions	27.79	0.000	0.902	1.04	0.53 to 2.06
Depression	34.31	0.000	0.184	1.93	0.73 to 5.08
Fears	37.02	0.000	0.816	1.09	0.53 to 2.25
Nervousness	22.89	0.000	0.354	1.36	0.71 to 2.61
Sadness	42.89	0.000	0.029	2.27	1.09 to 4.75
Worry	49.88	0.000	0.022	2.20	1.12 to 4.33
Loss of interest	24.57	0.000	0.059	2.25	0.97 to 5.25
Appearance	4.83	0.028	0.971	0.99	0.51 to 1.90
Indigestion	12.83	0.000	0.439	1.42	0.58 to 3.47
Skin dry/itchy	14.25	0.000	0.059	2.06	0.97 to 4.35
Tingling in hands/feet	10.27	0.001	0.004	2.52	1.34 to 4.75
Pain	4.48	0.034	0.970	0.99	0.54 to 1.81
Memory/concentration	8.00	0.005	0.774	0.91	0.50 to 1.69
Fatigue	14.71	0.000	0.582	1.18	0.65 to 2.16
Breathing	16.72	0.000	0.022	2.95	1.17 to 7.44
fear of tumor recurrence	44.18	0.000	0.005	2.54	1.33 to 4.85
worry about radiation safety	23.82	0.000	0.024	1.98	1.09 to 3.59
fear of tumor heredity	11.22	0.001	0.299	1.36	0.76 to 2.43
care about others' perceptions	23.58	0.000	0.539	1.24	0.62 to 2.49
Abbreviations: DT = Distress Thermometer.

In the quality of life survey of PTC patients, role function was the best (Mean = 91.69, SD = 14.20), cognitive function was the worst (Mean = 84.08, SD = 16.53), and insomnia (Mean = 18.30, SD = 22.62) and fatigue (Mean = 14.25, SD = 14.65) symptoms were the most severe (Supplementary Information S4). Higher DT scores and hypothyroidism were the most important factors contributing to decreased quality of life in PTC patients, followed by hoarseness symptoms (Supplementary Information S5).

In this study, the levels of distress and anxiety of PTC patients after receiving CBT-HEP intervention gradually and significantly relieved with the extension of time. Although the level of depression was also gradually decreased, but there was no statistically significant difference between the post-intervention and the six-month follow-up. In patients who did not receive CBT-HEP intervention, only distress and depression were significantly relieved during a certain period of time. The post-intervention questionnaire was administered prior to posttreatment whole-body iodine imaging. At this time, worry about the effectiveness of treatment and the discomfort of prolonged freedom restriction may be the main causes of increased anxiety and depression before discharge. In addition, when comparing the two groups of patients, the CBT-HEP intervention was effective and rapid in helping PTC patients to reduce their distress, anxiety and depression. However, when using chi-square tests to validate the results, CBT-HEP was found to be ineffective in alleviating depression, possibly because some patients' PHQ-9 scores decreased, but they were still higher than or equal to 5, which cannot be defined as depression remission.

In the critical factor analysis of distress and quality of life for all participants, women, living alone, hypothyroidism, negative emotions, tingling in the hands/feet, concern about treatment effectiveness and radiation safety were found to be the main factors leading to severe distress. Severe distress, hypothyroidism, and hoarseness were the main factors leading to decreased quality of life. In addition, most PTC patients suffer from severe insomnia and fatigue. In practice, personalized care for patients with the above characteristics, such as CBT-HEP intervention, can help PTC patients improve their quality of life as much as possible given the limited medical resources in China.

Relatively few studies have been conducted on interventions to alleviate psychological problems in thyroid cancer patients. A study [11] implemented in 60 patients with thyroid cancer found that psychological and behavioral intervention was effective in reducing patients' anxiety and depression. A study [12] conducted on 120 patients with thyroid cancer found that mindfulness-based stress reduction could also significantly alleviate the anxiety and depression of patients. Another studies [13, 14] using a psychological nursing intervention also found that psychological distress, depression and anxiety could be significantly reduced. All of the above studies are generally consistent with the findings of this paper. We cannot say that CBT-HEP intervention is necessarily superior to the above interventions, but we have innovatively added scientific knowledge to our intervention, which may have a longer lasting positive impact on patients given the limited nursing resources in China.

Some studies have found that gender [24], negative emotions [9, 25, 26], and hypothyroidism [27] would significantly affect the DT score and quality of life in patients with thyroid cancer, which is consistent with our research results. However, some studies thought age [28] and employment status [26] would significantly affect the DT score or that any demographic variables were not associated with DT scores in patients with thyroid cancer [25]. These outcomes are inconsistent with our research results. The reasons for the inconsistency may be related to the different ethnicities of these studies and the different independent variables included in the multifactorial analysis. In addition, our study found a novel point that patients' concerns about the effects of ¹³¹I treatment and radiation safety can lead to severe distress. We should be aware that most patients in China have a low level of education and are unable to actively access the correct and relevant information, so it is necessary to convey relevant knowledge to patients in China.

Regarding the quality of life of patients with thyroid cancer, a previous study [29] suggested that role function was the best and the cognitive function was the worst for thyroid cancer patients, which is consistent with this study. Some studies [29, 30] found that in the field of symptoms, fatigue was the most serious, followed by insomnia, which is slightly different from the findings of this study. The reasons for the inconsistency may be related to different lifestyles and races. The above article [29] also found occupation, education, income, marital status, physical activity, fruit intake, and type of surgery could significantly affect the quality of life of patients with thyroid cancer, which is not entirely consistent with this study. We did not find that marital status, physical activity, fruit intake, or type of surgery could significantly affect the quality of life. This may be because the independent variables included in the two studies were different; for example, we included hoarseness, hypothyroidism and DT scores, which could lead to inconsistent findings.

There are many limitations in this trial, such as: the small sample included in this trial; it was a single-center trial; the type of pathology included was single, only PTC; the independent variables included in the analysis were not comprehensive enough, for example, variables such as economic income and exercise were not included; in the intervention trial, the follow-up period was too short.

As the number of thyroid cancer patients increases, their quality of life is an issue that cannot be ignored. Our research can raise awareness of this issue, and medical staff can use the new psychological intervention method to help thyroid cancer patients relieve their psychological problems and improve their quality.

CBT-HEP is effective in relieving distress, anxiety and depression in PTC patients. In addition, female sex, lifestyle, hypothyroidism, negative emotions, related symptoms, ¹³¹I treatment effects and radiation safety are the main factors affecting patients' quality of life and mental health, and medical staff in China should focus on these patients and provide humane medical services.

Funding

This study was supported by the National Natural Science Foundation of China (Grant Nos. 81971595 and 81771812), the Innovation Spark Project of Sichuan University (Grant No. 2019SCUH0003) and 1·3·5 project for disciplines of excellence–Clinical Research Incubation Project, West China Hospital, Sichuan University (Grant No. 2020HXFH005).

Conflict of Interest Statement

The authors have declared no conflicts of interest.

Author contributions

Conceptualization: Chunyan Zhao, Zhiyun Jia; Methodology: Chunyan Zhao, Xin Xu; Formal analysis and investigation: Chunyan Zhao, Wei Diao; Writing - original draft preparation: Chunyan Zhao; Writing - review and editing: Chunyan Zhao, Lin Li; Funding acquisition: Zhiyun Jia; Resources: Zhiyun Jia, Lin Li; Supervision: Zhiyun Jia.

Ethics approval

The trial followed the Helsinki Declaration and International Ethics Guide for Human Biomedical Research. The trial protocol was approved by the ethical review board of West China Hospital of Sichuan University (Review No. 529 in 2019), and the clinical trial registration was completed (Registration No. ChiCTR1900025852).

Consent to participate

All participants provided written informed consent.

Consent to publish

Not applicable

Data availability

The original data can be obtained by sending an email to the corresponding author.

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Effect of cognitive behavior therapy based on the health education pathway on psychology of Chinese papillary thyroid carcinoma patients: A randomized controlled trial

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