Factors affecting the quality of life of patients undergoing hematopoietic stem cell transplantation : Application of the Symptom Management Model

DOI: https://doi.org/10.21203/rs.3.rs-1791042/v1

Abstract

Based on symptom management model, to analyze the relationships among symptom experience, symptom management strategies, self-management behavior, and quality of life among patients undergoing hematopoietic stem cell transplantation(HSCT) in Korea and to identify factors affecting quality of life.  Data of adult 67 patients of undergoing HSCT by convenience sampling at the university-affiliated hospital in Korea were analyzed. Using a self-reported structured questionnaire, date on symptom experience, symptom management strategies, self-management behavior, and quality of life were analyzed using Pearson’s correlation. Factor affecting quality of life were investigated using multiple regression analysis.  Quality of life showed significant negative correlation with symptom experience and significant positive correlations with symptom management strategies Factors influencing the quality of life included distress of symptom experience, symptom management strategies, and self-management behavior and explained 39.4% of all such factors. To improve quality of life in patients undergoing HSCT, important to manage symptoms well for simultaneous symptoms in HSCT. So, providing tailored nursing intervention based on a patient-focused and person-centered care approach for HSCT patients.

Introduction

In hematopoietic stem cell transplantations(HSCT), bone marrow failure, malignant bone marrow-origin diseases, and bone marrow abnormalities are completely destroyed after which normal hematopoietic stem cells are injected to reestablish hematopoietic capability. This expands the scope of the treatment to hemopathies, solid cancers, and refractory genetic diseases1. More than 1.5 million HSCT have been performed at over 1,500 transplant centers worldwide2. In South Korea, the total number of of HSCT patients accumulated as of 2021 is reported to be 36,592, and hematopoietic stem cell transplantation is increasing due to diversification of transplant medical technology and expansion of Korea medical insurance coverage3. As the number of such transplantations performed has increased, the survival rates have improved not only South Korea but also worldwide. However, the number of patients experiencing adverse reactions to HSCT is also increasing with an increase in the patients of treatment4. Notably, patients undergoing HSCT face physical and mental stress due to the toxicity of pretreatment procedures, the transplantation process, and the long recovery time5.

The pretreatment procedures that patients undergo before transplants include chemotherapy and radiotherapy to suppress immune and hematopoietic functions and destroy cancer cells. After a transplant, they are hospitalized in a protective isolation unit in South Korea for the engraftment of hematopoietic stem cells6. The average duration of hospitalization in a protective isolation unit in South Korea is about one month and is the most important and difficult period for patients7. In the first two weeks of hospitalization, the patient is in the most physically debilitating state of extreme immunosuppression, during which they may contract various infections. They may also experience physical discomfort in the form of sore throat, pain caused by mouth ulcers, nausea and vomiting, salivary hypofunction or hyperfunction, diarrhea, helplessness, fatigue, shortness of breath, coughing, headache, tingling of hands and feet, skin pigmentation, and emotional symptoms such as frustration and depression8. Thus, they may experience a wide range of adverse events associated with HSCT, from minimal side-effects to life-threatening issues. Based on the manageability of their symptoms, patients face physical and mental risks that threaten their quality of life9.

Previous studies on the correlation between adverse symptoms and quality of life in HSCT patients found that the symptoms that patients experience had a significant effect on their quality of life and that effective management positively influenced this10. As effective symptom management can also reduce pain for patients and improve their quality of life, the International Association of Clinical Research Nurses (IACRN) noted that symptom management holds priority in their agenda. Studying symptomatic management among HSCT patients involves a medical approach to specific symptoms related to fatigue, stomatitis, and neutropenia11. While there are studies on symptom management in patients with multiple myeloma and acute myeloid leukemia 12,13, there is a lack of research on the symptomatic management of concurrent symptoms in HSCT patients. Therefore, it is necessary to understand the symptom experience of patients undergoing HSCT and provide effective symptom management for better quality of life. Thus, we conduct our study based on the application of nursing theory.

Among the various extant theories regarding symptoms, we chose the symptom management model, a middle-range theory developed by Dodd 14, as the conceptual framework for this study. This theory encompasses symptom experience, symptom management strategies, and symptom outcomes considered to be the result of symptom management strategies and symptom experience. It is important to measure the frequency, intensity, and pain degree for each symptom experience in symptom management. In symptom management strategy, positive consequences of symptom relief, reduced pain, prevention of recurrence, improvement in the quality of life, or negative consequences of symptom recurrence, consistent or increased pain, and decreased quality of life are the results of trial and error. Thus, the emphasis is placed on adherence to improve the effectiveness of symptom management strategies. Although there is a risk of nonadherence to treatment in the presence of multiple symptom management strategies, adherence remains important for symptom management and outcomes. Self-management among patients indicates a proper beginning to a symptom management strategy and reveals more functional, effective, and creative strategies to improve a patient’s quality of life.

Previous studies based on symptom management model were conducted on preoperative patients 15, children tumor patients 16,17, solid cancer patients 18, uterine cancer patients 19, and family caregivers of cancer patients20. Inconsistent symptom experiences were attributed to the diverse disease types previous studied, as the symptom experiences became more severe, the effectiveness of symptom management strategies decreased, and the quality of life reduced. However, based on the symptom management model14 that provides a framework to recognize and analyze the patient’s subjective experience of symptoms from different perspectives and the abnormal indicating signs of disease that can be detected by individuals or others, studies should be conducted on patients who have various symptom experiences undergoing HSCT. These should be done in protective isolation units and with appropriate symptom management and adherence.

We partially revised symptom management model to account for the economic feasibility of the research model and analysis and identify items helpful to nursing practice. Symptom experience, symptom management strategy, and self-management behavior were all included to assess individual aspects, including patients’ demographic characteristics, environmental aspects indicating the degree of support of family or medical staff in aiding self-management, health, and disease aspects associated with HSCT, and factors influencing the symptom outcomes. All factors such as symptom experience, symptom management strategy, and self-management behavior are related, and this study focuses on quality of life as a symptom outcome. Therefore, factors such as cost, morbidity, prevalence, and mortality as symptom outcomes were excluded. Therefore, our theoretical framework comprises subject aspects, environmental aspects, health and disease aspects, symptom experience, symptom management strategy, self-management behavior, and quality of life.

This study aims to provide basic data to develop a nursing intervention for effective symptom management of HSCT patients by identifying factor of symptom experience, symptom management strategy, and self-management behavior with quality of life, based on symptom management model14 ithin an integrated theoretical framework. Figure 1 shows this framework, identifying improvements in the quality of life of patients undergoing HSCT.

Methods

Design

This study is a cross-sectional descriptive study that identifies factors that influence symptom experience, symptom management strategy, self-management behavior, and quality of life among patients undergoing HSCT.

Participants

Participants in the current study were adult patients undergoing HSCT in HSCT ward at S Hospital of C University in Seoul, South Korea. We included data for the period March 23 to June 7, 2016, from four criteria—patients who were 20 years or older, those admitted to a protective isolation unit, those within one to 14 days’recovery after HSCT, and who did not have important diseases that could affect symptom. The sample size was calculated using G-Power 3.1 with 6 independent variables, effect size 0.35 (large), power 0.9, significance level 0.05, two-sided test for multiple regression analysis. The minimum number of study was 57, and the dropout rate was considered. Therefore, a total of 68 patients were investigated. In this study, the final 67 patients were used for the final analysis, excluding 1 patient of the data with insufficient responses.

Measures

Characteristics of the Patients

Medical records and self-report questionnaires were used to investigate the general, environmental, and disease characteristics of patients. The degree of recognition of their support system in environmental characteristics was a self-report score calculated from the subjective response of each patient and recorded on a 10-point scale.

The instruments used for this research were as follows

1) The symptom experience was measured using the Symptom Frequency, Intensity and Distress questionnaire for stem-cell transplantation (SFID-SCT) 21. This instrument comprises 25 items—nausea, vomiting, fever, chills, cough, pain, dyspnea, fatigue, dry mouth, oral ulcers, changes in taste, diarrhea, constipation, skin changes, decreased appetite, sleep disorders, activity disorders, depression, anxiety, decreased concentration, memory disorders, hair loss, sexual problems, appearance changes, and eye problems. The symptom experience in the above 25 items were measured for the frequency. A 4-point scale was used for the intensity and distress of each symptom. The higher the score, the more severe was the symptom experience indicated. While 1 point meant “not severe at all,” 4 points meant “very severe.” At the time of development, the reliability of the instrument was measured by Cronbach’s alpha of 0.81, and in this study, a Cronbach’s alpha was 0 .93.

2) The symptom management strategy was measured using Appraisal of Self-Care Agency Scale-Revised (ASAS-R)22, modified to measure symptom management strategies and supplemented by five expert validations (one clinical professor of hematology, three nurses specialized in hematology, and one doctor of nursing science. The instrument comprised 15 items and three subsections—the acquisition of symptom management strategy, symptom management strategy development, and absence of symptom management strategy. A 5-point scale is used, and a higher score suggests higher symptom management strategies, with 1 point meaning “not at all” and 5 points meaning “very much.” The reliability of the instrument at the time of development was shown to be Cronbach’s alpha of 0 .90, and in this study, a Cronbach’s alpha was 0 .76.

3) Self-management behavior was measured using the framework for self-management behavior in HSCT patients revised by Kim 23. General self-management comprises 18 items and five subsections—infection prevention, diet, medication, communication with medical staff, and health care. Symptom management comprises 35 items and 13 subsections—nausea/vomiting, anorexia, dry mouth/stomatitis, diarrhea, constipation, skin changes, hair loss, fatigue, pain, changes in the eye, sleep disorders, depression, anxiety and stress. We used a 4-point scale, where 1 point indicated “not implemented at all,” while 4 points indicated “always well implemented.” A higher score meant that self-management was well implemented. The reliability of the tool at the time of development was measured as Cronbach’s alpha of 0.65 ~ 92 for general self-management and Cronbach’s alpha of 0.64 ~ 88 for symptom management. In this study, a Cronbach’s alpha was 0.90 for the total tool.

4) Quality of life was measured using the South Korean version (version 4) of the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) (Version 4) 24. FACT-BMT comprises 50 items and five subsections—physical status, social/family status, emotional status, functional status, and bone marrow transplantation (BMT) status. We used a 4-point scale, where 1 point meant “not at all,” and 4 points meant “quite a lot.” A higher score indicated higher quality of life. During its development, the reliability of the instrument was measured as Cronbach’s alpha of 0 .94, and in this study, a Cronbach’s alpha was 0 .82.

Ethics Approval And Informed Consent To Participate

This study was approved by the Research Ethics Council of C University Hospital in Seoul for the ethical approval(No. KC16QASI0243). The researcher explained the purpose of this study to the subjects when collecting data, explained that the anonymity of the participants and that the questionnaire could be stopped at any time if it violates the ethical part, and then the subjects signed the informed consent form before collecting data. At the same time as the questionnaire was distributed, informed consent was obtained after explaining to the subject that the patient's disease-related special document was to be inquired through the patient's electronic medical record. The data through the electronic medical record were managed by the study number, not the name of the patients, so that others could not identify it by creating a case record.

Data Collection

Data were collected from patients receiving HSCT in the HSCT ward at C University hospital in South Korea after review and approval from the institutional ethics committee. We requested the cooperation of the nursing department of the hospital to collect research data and obtained the informed consent of the nurses and faculty of the HSCT ward after explaining the purpose of the study. Subsequently, we visited patients who were admitted to the HSCT ward and met the inclusion criteria. We explained the purpose and procedure of the study, and after receiving written consent from the patients who agreed, we asked them to fill in the questionnaire. The survey took about 15 minutes, and we recorded the disease-related characteristics from the electronic medical records. All methods were performed in accordance with the relevant The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines and regulations.

Data Analysis

The Collected data were statistically analyzed according to the purpose of research using SPSS 21.0 program.

1) The general, environmental, disease-related characteristics, symptom experience, symptom management strategy, self-management behavior, and quality of life of the patients were analyzed using frequency, percentage, mean and standard deviation.

2) The symptom experience, symptom management strategy, self-management behavior, and quality of life according to the general, environmental, and disease-related characteristics of the patients were analyzed using T-test and one-way ANOVA.

3) The correlation between symptom experience, symptom management strategy, self-management behavior and quality of life of the patients was analyzed using correlation analysis.

4) Multiple regression analysis was used to identify factors affecting the patient's quality of life.

Results

General, Environmental, and Disease-Related Characteristics of the Patients

The patients were an average of 44.58 years old, with 67.2% males and 32.8% females. We found that 91.1% had an education level higher than high school, and 68.7% were married. Furthermore, 41.8% were office workers, and 43.3% had no religion. The perceived self-management ability was 6.49 points on average. While 49.3% relied on their spouses as supporting family members for self-management, 23.9% relied on their parents. The average level of perception on family support for self-management was 7.54 points, and 53.7% chose nurses, and 41.8% chose doctors. The average level of perception on support from medical faculty for self-management was 8.49 points. The most common diagnosis was leukemia (46.3%) and myelodysplastic syndrome (17.9%). For the type of transplantation, 29.9% were from their siblings, while 26.9% from others and the patient themselves(see Table 1).

Symptom experience, symptom management strategy, self-management behavior, quality of life of the patients

In this study, the symptom experience of patients undergoing hematopoietic stem cell transplantation consisted of frequency, intensity, and distress. The average of the patient's symptom frequency shown to be 15.22(range 0-25) on average. The average score for symptom intensity is 2.05±0.44 points(range 1-4) and the average score for symptom distress is 2.04±0.47 points(range 1-4). The mean score of the symptom management strategies was 3.55±0.45 points(range 1-4), indicating a high level of symptom management strategies. The average score of self-management behavior was 2.74 ±0.89points(range 1-4), indicating a low level of self-management behavior. The average score of quality of life was 1.95 points(range 1-4), indicating a low level of quality of life(Table 2).

Differences According to the Patients’ Characteristics 

Based on the patients’ characteristics, there were statistically significant differences in self-management behavior according to the degree of education (F = 3.979, p <.05). Self-management performance was shown to be higher in the college graduates’ group compared to the high school graduates’ group. For symptom experience, symptom management strategy, and self-management behavior according to the patients’ environmental characteristics, there were statistically significant differences. There was a statistically significant difference in the symptom management strategy according to the medical staff (F = 3.570, <.034). Higher symptom management strategies were found with nurses and doctors than with other medical faculties. But quality of life was not statistically significant differences in variable(see Table 1).

Relationship Between Symptom Experience, Symptom Management Strategy, Self-Management Behavior, and Quality of Life of the Patients

The correlation between the symptom experience, symptom management strategy, self-management behavior, and quality of life was as follows. Frequency and intensity of symptom experience (r = .898, p <.001), frequency and pain of symptom experience (r = .879, p <.001), and intensity and pain of symptom experience (r = .977, p <.001) showed statistically significant positive correlations, suggesting that the frequency, intensity, and pain of symptom experience increased together. Frequency of symptom experience and quality of life (r =-. 378, p <.001), intensity and quality of life (r =-. 450, p <.001), and pain and quality of life (r =-. 469, <.001) showed statistically significant negative correlations, suggesting that the lower the symptom experience, the higher the quality of life. A patient’s symptom management strategy and quality of life (r = .323, <.001), self-management behavior and quality of life (r = .362, p <.001) showed statistically significant positive correlations, suggesting that the better the symptom management strategy and the better self-management, the higher the quality of life (see Table 3).

Influencing Factors on Quality of Life of Patients

Multiple regression analysis was conducted to identify factors affecting the quality of life of the patients. The regression model was significant (F = 15.307, <.001), and the tolerance limits and variance inflation factor (VIF) values were identified to test for multicollinearity. The VIF of the main independent variable was 1.1 or less, indicating no multicollinearity. Symptom experience (frequency, intensity, and distress), symptom management strategy, and self-management behavior influenced the quality of life with an explanatory power of 39.2%. We see that the higher the symptom management strategy (β = .343, p <.001), the higher the self-management behavior (β = .221, p = .029), and the lower the pain in symptom experience (β = -.482, p <. 001), the more was its influence on the quality of life of subjects undergoing HSCT (see Table 4).

Discussion

Based on the symptom management model, we find correlations between symptom experience, symptom management strategy, self-management behavior, and quality of life and identify the factors influencing the quality of life as symptom experience, symptom management strategy, and self-management behavior.

In this study, we see that the higher the frequency, intensity, and pain of symptoms, the lower is the quality of life with respect to the symptom experience of patients. These findings are consistent previous study 9, on changes in the quality of life up to one year after transplantation. They state that the higher the scores of fatigue, anorexia, and pain, the lower is the quality of life. Furthermore, as reported in studies examining the symptoms and quality of life of HSCT patients 4,25, regular evaluation and management of symptoms are important as the degree of symptom experience directly affects the quality of life. As intervention of symptom experience can improve the quality of life, appropriate management is needed. Thus, we recommend that nursing intervention should be actively conducted to improve the quality of life of patients undergoing HSCT.

Moreover, the higher the symptom management strategy of HSCT, the higher is the quality of life of the patients. These results are consistent with Chou’s findings from their study on cancer patients based on symptom management model 18, reporting moderate quality of life for groups using an average of two or three self-management strategies. A study on patients with preoperative thirst using symptom management model 15 showed that nursing interventions to relieve preoperative thirst had a positive effect on the functional status of symptom outcomes, causing emotional state changes in patients. Although the symptom management strategy and symptom outcomes were measured using a different tool in this study, the quality of life is expected to increase as the functional and emotional states of patients change positively through proper symptom management. Therefore, studies regarding the developments of personalized nursing strategies, interventions, and clinical application should be conducted to improve the quality of life of the patients, a symptomatic outcome of HSCT.

In this study, we also found that the higher the self-management behavior, the higher was the quality of life of the patients. A study by Sumdaengrit 19 on cervical cancer patients reported that the greater the symptom experience, the lower was the self-management efficiency. However, there was a U-shaped increase in efficiency as the symptom experience decreased over time. Here, we examine the data of a different group of patients and find no significant difference between symptom experience and self-management behavior. Thus, it is necessary to examine the extent of symptom experience and self-management behavior and their correlation with the quality of life in HSCT patients through repeated further studies, expanding the range of patients.

Regarding the factors influencing the quality of life, the results showed that the lower the distress of symptom experience and the better the symptom management strategy, the better was the self-management behavior, supporting some findings of symptom management model. These include the conclusion that symptom management strategies result in relieving symptoms, reducing the distress of symptoms, preventing recurrence, and improving the quality of life. For about a month on their own without a caregiver in a protective isolation unit, patients may require a different level of need, and therefore, a different approach to implementing symptom management strategies and self-management to cope with various symptoms 26. Therefore, patient-centered care and emotional supportive care in limited isolation units such as visit times and outside food intake are instrumental in improving the quality of life of patients undergoing HSCT. In addition to nurses and doctors were the supporting medical faculty for symptom management of patients undergoing HSCT. We see that these findings are consistent with those of Kang 7, who found that the most contacted medical staff during the HSCT in the isolation unit are nurses who spent the maximum time with patients. Thus, there is a need for medical staff to actively manage timing, circumstances, and responses to improve patient management strategies27 However, in this study, we do not examine the factors that affect symptom management strategy and self-management behavior, suggesting the need for future studies to look into how each factor is affected by each other and provide a strategy to improve them.

Our findings support the theory that symptom outcomes arise from symptom experience, symptom management strategies, and adherence as presented in the symptom management model. It is also consistent with previous theories 15,18 that state that symptom experience and symptom management strategies are supported by symptom outcomes. We present the correlation of a patient’s symptom experience, symptom management strategy, and self-management behavior with their quality of life. However, the impact analysis of symptom results showed that only partial factors were supported for general, environmental, disease, symptom experience, symptom management strategy, and self-management behavior variables. Thus, this study fails to measure various variables that affect the quality of life of patients undergoing HSCT. It is necessary to develop a professional and individualized nursing strategy to establish and implement a symptom management strategy to improve the quality of life of patients based on the various aspects of the symptom management model and the simultaneous occurrence of symptom experiences.

Although the hospitals included in this study perform most cases of HSCT in South Korea, this study is limited by its cross-sectional descriptive nature, sampling those patients admitted to the HSCT ward during the study period. Therefore, care must be taken when generalizing or expanding the findings of this study. While symptom management model 14—the theoretical framework of this study—described that all domains affect each other, we only measure and investigate the social environment and not the cultural factors. Nevertheless, the causal relationship between relevant variables was investigated in patients undergoing HSCT based on symptom management model. It is significant in that a theoretical basis was provided to develop the most effective interventions to improve the quality of life of HSCT patients.

Conclusion

In the findings, we find correlations between symptom experience, symptom management strategy, self-management behavior, and quality of life and identify the factors influencing the quality of life as symptom experience(distress), symptom management strategy, and self-management behavior. While this study was conducted to identify the influence of factors on patients undergoing HSCT and provide a basis for nursing intervention development, we also found that for factors affecting the quality of life of the patients, the more the symptomatic experience of the patient, the lower the quality of life. The higher the symptom management strategy and the better the self-management behavior, the higher is the quality of life. Through this study, we aimed to provide a foundation for nursing intervention development by describing the symptom experience of patients undergoing HSCT, the symptom management strategies, symptom outcomes, and the factors affecting the quality of life as the symptom outcome. These results suggest that it is necessary to develop individualized interventions to regularly evaluate and manage symptom experience and construct a clinical standard nursing plan to improve the quality of life of patients undergoing HSCT. Oncology nurses need to conduct continuous patient education and provide supportive care to enable patients to consistently manage themselves.

Based on this study, recommend the following. First, there is a need to develop programs on nursing interventions for symptom management and identify its effects using longitudinal identification on patients undergoing HSCT to enable continuous improvement in their quality of life. Second, it is necessary to expand the target population to children and adolescents undergoing hematopoietic stem cell transplantation, to find out whether there are differences from adults undergoing hematopoietic stem cell transplantation, and to develop customized nursing interventions for each patient.

Declarations

Data availability

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Acknowledgements

Nothing to disclose.

Authors' contributions

E.J., S.K., H.L. and S.L. contributed to the study concept and design method. E.J and collected and prepared the data. E.J., S.K. H.L conducted the statistical analyses and interpreted the data. E.J contributed original draft. E.J., S.K., H.L., and S.L. contributed review draft. All authors reviewed the manuscript.

Funding  

None

Competing interests

The authors declare that they have no competing interests.

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Tables

Tables 1 to 4 are available in the Supplementary Files section