Parallel mediation analysis on social support and appropriate medication self-efficacy in cancer-related fatigue and oral chemotherapy adherence

doi:10.21203/rs.3.rs-4695706/v1

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Research Article

Parallel mediation analysis on social support and appropriate medication self-efficacy in cancer-related fatigue and oral chemotherapy adherence

https://doi.org/10.21203/rs.3.rs-4695706/v1

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Purpose The study explores the parallel mediating effect of social support and suitable medication self-efficacy between cancer-related fatigue (CRF) and oral chemotherapy adherence in glioma patients to improve efficacy.

Patients and methods 464 glioma patients were recruited through convenient sampling from a Three-A hospital in Urumqi, Xinjiang, and Three-A hospitals in Chengdu, Sichuan, between December 2023 and June 2024. The general information questionnaire and Brief Fatigue Inventory (BFI) were chosen to investigate the general information and degree of fatigue in such patients. The Social Support Rating Scale (SSRS), Self-Efficacy for Appropriate Medication Use Scale (SEAMS), and 8-Item Morisky Medication Adherence Scale (MMAS-8) helped evaluate the social support degree, appropriate medication self-efficacy, and medication adherence.

Results The scores of SSRS, SEAMS, BFI, and MMAS-8 were 38.3±7.29, 27.83±6.66, 4.57±1.48, and 4.53±1.92, respectively. Pearson correlation analysis indicated that oral chemotherapy adherence is negatively associated with CRF (P<0.01) but positively correlates with appropriate medication self-efficacy and social support. Three statistical methods, causal stepwise analysis, Bootstrap, and Mplus, confirmed that SSRS and SEAMS exert complete mediating effects. This accounted for 59.09% and 50.84% of the total effects, respectively. The indirect SEAMS effect pathway is affected by the masking effect.

Conclusion:CRF can directly suppress the oral chemotherapy adherence of glioma patients, influenced by social support and suitable medication self-efficacy.

Glioma

Chemotherapy

Cancer-related fatigue

Adherence

Glioma is the most common primary malignant tumor within the brain and spinal cord, accounting for nearly 60%-70% of intracranial malignant tumors.^[1] Due to the high recurrence rate after surgical resection, glioma leads to heavy financial and psychological burdens to patients. Currently, the treatment protocol is surgery supplemented with temozolomide chemotherapy.^[2] Studies have established that oral chemotherapeutic agents enhance disease prognosis and survival rates.^{[3, 4]} Based on the five dimensions of medication adherence proposed by WHO,^[5] the current study investigates the mediating effects of social support and suitable medication self-efficacy between glioma-associated fatigue and oral chemotherapy adherence concerning socioeconomics, medical care, patients, treatment, and disease. The study will facilitate the development of effective measures to improve the efficacy and quality of life of glioma patients.

2.1 The subject of the study

Based on the sample size calculation formula in a cross-sectional study^[6], their sample size should be 5–10 times the number of variables. The current research has 19 variables. If 10% of the samples are considered invalid, the sample size will be 238variables. Therefore, between December 2023 and March 2024, at least 238 glioma patients who satisfied the inclusion and exclusion criteria were selected from three Three-A hospitals in Urumqi and one in Chengdu, Sichuan Province.

Inclusion criteria: ① Patients aged ≥ 18 years; ② Patients diagnosed with glioma after surgery and regularly treated with chemotherapy drugs; ③ Patients who could communicate normally; ④ Patients who volunteered to participate in the study; ⑤ Patients who fully understood the purpose, nature, and method of the investigation, and agreed to sign the informed consent form. Exclusion criteria: ① Patients with mental and speech disorders who could not communicate normally; ② Patients with severe cognitive impairment; ③ Patients with fatigue induced by hypothyroidism, adrenal cortex hypofunction, etc.; ④ Patients unwilling to participate in the investigation. This is supported by a unique research project of Xinjiang Autonomous Region regional cooperation and innovation (Science and technology Assistance project of Xinjiang Autonomous Region), which is No.2022E02135 and This study has been approved by the Second Affiliated Medical Ethics Committee of Xinjiang Medical University under review of batch number 2022H021.

2.2 Research methodology

The research tools were selected: ① General information questionnaire: self-designed after consulting relevant literature; ② Brief Fatigue Inventory (BFI): The score was procured by dividing nine fatigue point items by 9. The higher the score, the heavier the fatigue. According to clinical verification,^[7] the structural validity was 0.82–0.97.^[8] ③ The eight-item Morisky Medication Adherence Scale (MMAS-8) revealed that Cronbach's α coefficient was 0.83. It helped evaluate the oral chemotherapy adherence of chronic disease patients.^[9] Patients with eight scores have a high adherence level, while those with 6–7 scores have a medium adherence level. However, patients with < 6 scores have a low adherence level. ④ Xiao Shuiyuan formulated the Social Support Rating Scale (SSRS).^[10] The Cronbach's α coefficient of each dimension in the scale (three dimensions in total) was higher than 0.8. ⑤ Risser et al. developed the Self-efficacy for Appropriate Medication Use Scale (SEAMS).^[11] Cronbach's α coefficient was 0.934, with a retest reliability of 0.932. The scale had two dimensions, and the higher the score, the higher the self-efficacy of appropriate medication in patients.

2.3 Survey Methods

The research team comprised three members. The team leader took charge of overall design and quality control. In contrast, other members were responsible for coordination during the survey process, participant recruitment, and data collection. The survey was performed via convenience sampling, and questionnaires were distributed to glioma patients who undertook chemotherapy in four selected Three-A hospitals between December 2023 and June 2024. A total of 480 questionnaires were distributed in this study, which were filled out under strict quality control. After invalid questionnaires were excluded, 464 valid questionnaires remained, with a recovery rate of 95.8%.

2.4 Statistical Methods

Two personnel utilized the Excel 2021 software for data entry. The SPSS 26.0 software facilitated statistical analysis. Pearson correlation analysis was adopted for correlation analysis. The AMOS 24.0 software was chosen to build SEM. The mediating effect was assessed using the causal stepwise regression and Bootstrap methods to perform 1000 repeated sampling tests. The Mplus software helped display the results, and P < 0.05 indicated a statistically significant difference.

3.1 General information survey

A total of 464 patients were investigated; their general information is depicted in Table 1.

Table 1

Comparison of general information (n = 464)
Item	Group	Case number (percentage %)	Item	Group	Case number (percentage %)
Age(\(\:\stackrel{-}{\chi\:}\)±s)	(48.94 ± 15.08)		Burden in medical expense	No burden	173(37.3)
Gender	Male	233(50.2)		Light burden	181(39.0)
	Female	231(49.8)		Heavy burden	110(23.7)
Marital status	Married	356(76.7)	Health insurance	Health insurance	404(87.1)
	Single	108(23.3)		Self-paid	60(12.9)
Education level	Elementary school or below	78(16.8)	Glioma category	Low grade	241(51.9)
	Junior high school	123(26.5)		High grade	223(48.1)
	Senior high school	120(25.9)	Other chronic diseases	Yes	243(52.4)
	College or above	143(30.8)		No	221(47.6)
Occupation	In-service	284(61.2)	Types of oral drugs	≤ 2 types	233(50.2)
	Unemployed	180(38.8)		≥ 3 types	231(49.8)
Caregiver	Mate	248(53.4)	Regular medicine	Temozolomide	371(80.0)
	Children	171(36.9)		Other	93(20.0)
	Other	45(9.7)	Medication duration	≤ 6 months	264(56.9)
Average monthly income	<3,000	205(44.2)		>6 months	200(43.1)
	≥ 3,000	259(55.8)	Recognition degree	Known well	151(32.3)
Income source	Oneself	191(41.2)		Partially known	170(36.6)
	Mate	139(30.0)		Not known	143(30.8)
	Children	86(18.5)	Healthcare trust	Full trust	255(55.0)
	Other	48(10.3)		Partial trust	143(30.8)
Adverse reaction(\(\:\stackrel{-}{\chi\:}\)±s)	(2.14 ± 1.45)			No trust	66(14.2)
			Detailed medication education	Yes	362(78.0)
				No	102(22.0)

3.2 Descriptive statistics of cancer-related fatigue (CRF), social support, suitable medication self-efficacy, and medication adherence in glioma patients.

The incidence of adverse events due to medication adherence among 464 glioma patients is 71.6%. There were 332b cases in total, of which 28.4% of patients showed high adherence (132 cases in total). The investigation of the relationship between the four variables is represented in Table 2. The medication adherence of glioma patients is positively associated with social support (r = 0.548, P<0.001) and appropriate medication self-efficacy (r = 0.420, P<0.001)while negatively correlated with CRF (r=-0.171, P<0.001). After stratified analysis, the correlation of general information-related variables was explored with CRF and medication adherence, indicating a significant correlation.

Table 2

Correlation coefficients of CRF, social support, suitable medication self-efficacy, and medication adherence (n=464)
Item	\(\:\stackrel{-}{\chi\:}\)±s	CRF	Social support	Appropriate medication self-efficacy	Medication adherence
CRF	4.57 ± 1.48	1
Social support	38.3 ± 7.29	-0.309^**	1
Appropriate medication self-efficacy	28.73 ± 6.66	-0.207^**	0.349^**	1
Medication adherence	4.53 ± 1.92	-0.171^**	0.548^**	0.420^**	1
Note: ** P < 0.001 depicts a strong correlation between variables with statistical significance.

3.3 Parallel mediating effect model of social support, suitable medication self-efficacy, CRF, and medication adherence

This study conducted a mediating effect analysis by setting oral chemotherapy adherence of glioma patients as the dependent variable and appropriate medication self-efficacy, social support, and CRF as mediating independent variables. The results of the parallel mediating effect analysis are depicted in Fig. 1. When social support, CRF, and appropriate medication self-efficacy are chosen to predict medication adherence, social support and appropriate medication self-efficacy depict significantly positive predictions (β = 0.548, P<0.001;β = 0.1498, P<0.001). Simultaneously, CRF demonstrates significantly negative prediction (β = 0.1475, P<0.001).

3.4 Inter-effect relationship

After repeated sampling 5,000 times using the Bootstrap method, a significant relationship was obtained between mediating effects, as depicted in Table 3 and Table 4. The results demonstrate that 95% CI (-0.01,0.13) of the direct effect contains 0, suggesting that the mediating effect is insignificant and the direct effect accounts for 13.63%. Among them, 95% CI (-0.255,-0.122), (-0.109,-0.037) of the indirect effects of social support and appropriate medication self-efficacy do not contain 0, depicting a significant mediating effect. Therefore, social support and appropriate medication self-efficacy wield partial mediating effects. Moreover, the mediating effect of social support accounts for 59.09%. Due to the masking effect of appropriate medication self-efficacy,^[12] the absolute value of the direct and indirect effect proportion was measured, and the effect value is |ab/c´|=50.84%. And the results of Mplus analysis confirmed the complete mediation of social support and Appropriate medication self-efficacy,The results (P<0.001) are consistent with the Bootstrap analysis results and retain the relationships and confidence intervals among the factors as shown in Fig. 2.Thus, the pathway was insignificant when the mediating analysis was carried out on social support and appropriate medication self-efficacy. Furthermore, CRF did not affect appropriate medication self-efficacy in developing a complete mediation model.

Table 3

The direct effect test using SPSS
Pathway	\(\:\text{U}\text{n}\text{s}\text{t}\text{a}\text{n}\text{d}\text{a}\text{r}\text{d}\text{i}\text{z}\text{e}\text{d}\:\text{c}\text{o}\text{e}\text{f}\text{f}\text{i}\text{c}\text{i}\text{e}\text{n}\text{t}\text{s}\)	\(\:\text{S}\text{t}\text{a}\text{n}\text{d}\text{a}\text{r}\text{d}\text{i}\text{z}\text{e}\text{d}\:\) \(\:\text{c}\text{o}\text{e}\text{f}\text{f}\text{i}\text{c}\text{i}\text{e}\text{n}\text{t}\text{s}\)	S.E.	T value	P
CRF→Social support	-1.512	-0.309	0.217	-6.975	<0.001
CRF→Appropriate medication self-efficacy	-0.929	-0.207	0.204	-4.557	<0.001
CRF→Medication adherence	0.304	0.027	0.675	0.675	>0.05
Social support→Medication adherence	0.122	0.464	0.011	11.264	<0.001
Appropriate medication self-efficacy→Medication adherence	0.076	0.264	0.012	6.601	<0.001
Note: P > 0.05 depicts that the difference was not statistically significant; P < 0.05 indicates a significant statistical difference.

Table 4

Bootstrap analysis
Effect relationship	Effect value	LLCI	ULCI	P value	Percentage
Direct effect: CRF→Medication adherence	0.034	0.001	0.13	0.500	13.63%
Indirect effect: CRF→Social support→Medication adherence	-0.185	-0.255	-0.122	<0.005	59.09%
Indirect effect: CRF→Appropriate medication self-efficacy→Medication adherence	-0.071	-0.109	-0.037	<0.005	50.84%
Total effect: CRF→Medication adherence	-0.221	-0.34	-0.10	<0.005	-

Oral chemotherapy adherence of glioma patients is significant regarding disease prognosis and quality of life improvement during the disease course.^{[3, 4]} CRF depicts cancer-associated physical and mental illness characterized by a reduction in bodily functions and negative moods. Social support is the visibly objective and subjectively experienced emotional support provided by society and the patient's relatives. Studies have revealed that families with cancer patients are financially vulnerable and are accompanied by elevated caregiver burdens. Good social support has a positive role in the self-management of oncology patients.^{[13, 14]} Appropriate medication self-efficacy is an individual's confidence and ability to follow medical advice and adopt accurate medication behaviors. Suitable medication efficacy is positively associated with the oral administration of chemotherapeutic drugs in cancer patients. Therefore, factors like multiple drug experiences and inappropriate drug use may affect oral drug adherence.^{[15, 16]} The study results confirm that social support and appropriate medication self-efficacy have a parallel regulating relationship between glioma-correlated fatigue and oral chemotherapy adherence.

4.1 CRF can negatively and directly predict oral chemotherapy adherence among glioma patients

The findings are similar to previous studies: CRF negatively correlates with oral chemotherapy adherence in glioma patients.^{[17, 18]} CRF is also affected by symptom clusters. This was reflected in drug administration, general activities, moods, daily tasks, relationships with others, and the ability to enjoy life. CRF generated in glioma patients was mainly at a moderate level in several studies investigating the current status of such patients,^[19–21] which is consistent with the study results. According to the “Clinical Practice Guidelines for CRF in China (2021),” medical staff must strengthen the popularization of CRF knowledge and ease the anxiety of patients and their families. Thus, medical staff will carry out corresponding psychological care, teach patients to manage drugs correctly, strengthen the assessment of cancer patients, and conduct better pain care. Several studies have supported the theory that CRF is negatively associated with self-efficacy. Since self-efficacy may be affected by single factors, such as individual differences, research design, and sample size, it is necessary to explore the complex relationship between CRF and oral chemotherapy adherence.

4.2 Mediating effect of social support between CRF and medication adherence

Social support is a protective factor for cancer patients. It plays a critical positive role in the CRF of patients, including psychological and material support from patients' relatives, friends, or groups. Better social support will decrease the negative impact of CRF on patients.^[22] A study by Linghu Xiaojuan^[23] has observed that social support is associated with self-efficacy. When patients receive more social support, their self-efficacy will increase, which is consistent with the study results. Social support is closely associated with CRF and medication adherence. In this study, the satisfaction with social support in glioma patients is influenced by glioma type and medication duration. Caregivers must play their role in providing living assistance while paying attention to patients' moods. As a complaint subject, the caregiver must patiently empathize with the patient. Medical staff should be concerned about patients' emotional changes during follow-up visits, offer emotional help, and teach the patients to use social and family resources to minimize CRF. Therefore, providing targeted, timely, and effective material and spiritual means can alleviate patients' CRF, decrease their adverse drug experience, and enhance oral chemotherapy adherence by promoting patients' medication adherence. It is necessary to conduct analysis and research because the potential factors are insufficient.

4.3 Mediating effect of appropriate medication self-efficacy between CRF and medication adherence

Patients with high self-efficacy have a higher treatment adherence level.^{[24, 25]} The study results confirm that a strong sense of appropriate medication self-efficacy is conducive to improving oral chemotherapy adherence in glioma patients. The stronger the CRF, the lower the appropriate medication self-efficacy. Previous studies have indicated that CRF is an influencing factor of self-efficacy, and the discomfort and negative emotions of cancer patients will elevate the burdens of cancer patients and impact their ability to live and work. This will directly affect their self-efficacy, decreasing the behavioral ability level of patients.^{[26, 27]} Therefore, patients must develop strong self-efficacy to conquer CRF. Moreover, self-efficacy can be improved by patients' successful experiences. Fixing small daily goals, making a to-do list, and crossing off the completed items can motivate patients and improve their achievement. According to the perspective of appropriate medication self-efficacy, if patients are in a challenging situation for medication, measures can be adopted. These include strengthening human care, adopting automatic drug splitting and packaging technology, and arranging the medication order following the doctor's prescription. If the patient remains uncertain, we can set up a reminder tool, a convenient means of inquiry, and a contact person who can respond promptly. Therefore, improving the appropriate medication self-efficacy in glioma patients can help improve medication adherence. This plays a significant role in the relationship between CRF and medication adherence. However, exploring a more adequate and effective means of improving medication adherence in a clinical setting is necessary because of the research scope limitations, individual differences, and imbalances.

4.4 Social support and appropriate medication self-efficacy as protective factors in the CRF effect on oral chemotherapy adherence of glioma patients

In this study, social support and appropriate medication self-efficacy are mediators to validate the predictive role of this pathway on medication adherence of glioma patients. According to the research results, the median effect of SSRS accounts for 59.09%. SEAM shows a mediating and masking effect, accounting for 50.84%. Thus, fatigue patients can synthesize masking effects through appropriate medication, which does not affect medication adherence. Moreover, appropriate medication self-efficacy involves not only individuals but also the medication education provided by medical staff. Studies have found that patients' distrust of medical staff severely affects their enthusiasm for treatment. Hence, other than popularizing health knowledge via online publicity and distribution of diagnosis and treatment manuals, medical staff must communicate with patients, answer their questions, and explain patiently. Medical staff must offer more compassion, consideration, and patience during service to improve mutual understanding between doctors and patients.

Therefore, the current study establishes that social support and appropriate medication self-efficacy are protective mediators that can help decipher the impact of CRF on oral chemotherapy adherence in glioma patients. CRF in glioma patients affects medication adherence and is affected by two protective factors. The current result provides a reference for the clinical investigation of the current status and influencing factors of oral chemotherapy adherence in glioma patients. Therefore, the chemotherapy adherence, prognosis, and sense of well-being of cancer patients will be improved. However, the current study has yet to be conducted as a longitudinal cohort study, and the samples are selected from Xinjiang and Sichuan provinces to optimize the research content.

Conflict of Interest Statement:

No potential confilct of interest was reported by the authors.

Statement

This paper confirms that it meets the ethical standards specified in the 1964 Declaration of Helsinki.The study respects the autonomy of the subjects and has obtained their consent. We ensure that the study design and implementation are in accordance with scientific norms and follow ethical principles and cause no unnecessary harm or risk to the subjects. As the researchers, we guarantee the privacy right and protect the patients' privacy. In addition, considering the fair allocation of medical resources, we ensure that fair medical services are implemented in medical practice.

Funding:

This study was supported by Science and technology support Xinjiang(2022E02135).

Author Contribution

All authors reviewed the manuscript.Kaixuan Bao and Kaiyu Bao:contributed equally to this manuscript, Conceptualization, Methodology, Software Priya.Zhongyan Deng: Data curation, Writing- Original draft preparation.Peng Du: Visualization, Investigation.Kaiyu Bao: Supervision.Kaixuan Bao: Ajay Kumar: Software, Validation.Kaixuan Bao: Writing-Reviewing and Editing,

Acknowledgement

All authors reviewed the manuscript. Kaixuan Bao and Kaiyu Bao:contributed equally to this manuscript, Conceptualization, Methodology, Software Priya. Zhongyan Deng: Data curation, Writing- Original draft preparation. Peng Du: Visualization, Investigation. Kaiyu Bao: Supervision. Kaixuan Bao: Ajay Kumar: Software, Validation. Kaixuan Bao: Writing-Reviewing and Editing.

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Parallel mediation analysis on social support and appropriate medication self-efficacy in cancer-related fatigue and oral chemotherapy adherence

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Abstract

Figures

1 Introduction

2 Subjects and Methods

2.1 The subject of the study

2.2 Research methodology

2.3 Survey Methods

2.4 Statistical Methods

3 Results

3.1 General information survey

3.3 Parallel mediating effect model of social support, suitable medication self-efficacy, CRF, and medication adherence

3.4 Inter-effect relationship

4 Discussion

4.1 CRF can negatively and directly predict oral chemotherapy adherence among glioma patients

4.2 Mediating effect of social support between CRF and medication adherence

4.3 Mediating effect of appropriate medication self-efficacy between CRF and medication adherence

Declarations

Conflict of Interest Statement:

Funding:

Author Contribution

Acknowledgement

References

Additional Declarations

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