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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 3  |  Issue : 4  |  Page : 736-741

Incidence and severity of self-reported chemotherapy side-effects in patients with hematolymphoid malignancies: A cross-sectional study


College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India

Date of Submission16-Mar-2020
Date of Decision23-Aug-2020
Date of Acceptance15-Sep-2020
Date of Web Publication25-Dec-2020

Correspondence Address:
Kusum K Rohilla
All India Institute of Medical Sciences, Rishikesh, Uttarakhand
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/CRST.CRST_87_20

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  Abstract 


Background: Chemotherapy is an indispensable part of the treatment regimen for most cancer types. However, it is difficult to predict the chemotherapy-related side effects in patients with cancer.
Objectives: In this study, we aimed to assess the incidence and severity of self-reported chemotherapy-related side effects in patients with cancer.
Materials and Methods: This cross-sectional study, with a univariate descriptive design was conducted on patients with blood cancers, including leukemia, lymphoma, and myeloma. Patients who were admitted to the hemato-oncology department of our tertiary care center in northern India to receive the second cycle of chemotherapy were interviewed. Patients were interviewed regarding the symptoms they experienced after the first cycle of chemotherapy using the chemotherapy symptom assessment scale. The incidence of the chemotherapy side-effects experienced by the patients after the first cycle of chemotherapy was assessed, and the most severe and common symptoms that led to botheration in the patients receiving chemotherapy were identified.
Results: A total of 100 patients were enrolled in the study. Majority of the patients were men and aged between 41 and 50 years, with a diagnosis of lymphoma and an Eastern Cooperative Oncology group performance status of 1. The five most common severe symptoms reported by the patients after receiving the first cycle of chemotherapy were nausea, vomiting, constipation, pain, and shortness of breath. The three symptoms that led to maximum botheration in the patients after the first cycle of chemotherapy were nausea, vomiting, and diarrhea. The five symptoms that caused the least botheration in the patients were constipation, pain, change in temperature, problems with the skin, and problems with the mouth.
Conclusion: The most common symptom experienced by the patients is nausea (93%), which is also the most commonly experienced severe symptom (80%). Identifying these symptoms and their severity can help in planning symptom management more comprehensively. Moreover, planned health education for patients with cancer can help us provide better evidence-based quality care to those receiving chemotherapy.

Keywords: Chemotherapy-related side effect, self-reported chemotherapy side effect, PRO, patient reported outcome


How to cite this article:
Batra A, Kalyani C V, Rohilla KK. Incidence and severity of self-reported chemotherapy side-effects in patients with hematolymphoid malignancies: A cross-sectional study. Cancer Res Stat Treat 2020;3:736-41

How to cite this URL:
Batra A, Kalyani C V, Rohilla KK. Incidence and severity of self-reported chemotherapy side-effects in patients with hematolymphoid malignancies: A cross-sectional study. Cancer Res Stat Treat [serial online] 2020 [cited 2021 Jan 20];3:736-41. Available from: https://www.crstonline.com/text.asp?2020/3/4/736/305018




  Introduction Top


Cancer is a major noncommunicable disease with a considerable global burden. According to the World Health Organization 2018 report, the burden of new cancer cases was estimated to be around 18.1 million, with approximately 9.6 million deaths due to cancer. Globally, about one in every eight men and one in every eleven women die from cancer.[1] If deaths due to cancer continue to increase as projected, by the year 2030, there will be an estimated 13.1 million deaths due to cancer. The scenario is similar in India. Globally, around 2.25 million people are living with cancer, and around 7.84 million deaths occur due to cancer annually.[2]

Chemotherapy is the mainstay of treatment for most cancers. In the last three decades, chemotherapeutic agents and their usage has evolved.[3] In a study conducted in 1976 patients with cancer at the Royal Marsden Hospital in London, England, a total of 161 deaths (8%) were reported during the first 30 days after the start of chemotherapy. Of these, 124 (77%) of the deaths were unrelated to chemotherapy, and a majority of them occurred due to progressive disease. However, 12 (7.5%) deaths were related to chemotherapy, of which 6 occurred in patients with solid tumors and 6 in patients with hematological malignancies.[4] Failure to manage the adverse effects of chemotherapy in a timely manner could have life-threatening consequences. Side effects of chemotherapy can be categorized as immediate (occurring within 1 week) and late (occurring after 1 week) side effects. Late side effects predominantly consist of physical symptoms, psychosocial issues, and poor quality of life of patients with cancer.[2],[5],[6] On the other hand, immediate side effects develop right after the treatment has been completed and include nausea and vomiting.[7],[8] The major chemotherapy-related side effects reported by various studies include nausea, vomiting,[9] fatigue,[10] loss of appetite,[11] hair loss,[12] altered bowel habits,[13] pain,[14] and depression.[15] In many patients, these side effects can lead to treatment discontinuation, morbidity, and even mortality.

Routine reporting of adverse effects is pivotal for planning dose reduction, treatment delay/withdrawal, supportive care, and prophylaxis of side effects.[7] It is mandatory to report the adverse effects of drugs when conducting clinical trials and developing new chemotherapeutic regimens.[8]

Severity of the side effects of chemotherapy may vary depending on the health and nutritional status of the patients and hence, is difficult to predict. Therefore, despite the improved efficacy of the chemotherapeutic agents, it is essential to identify both the immediate and late side effects associated with them, which are a major source of concern for patients with cancer.[16] Therefore, in this study, we aimed to assess the proportion of patients with hematolymphoid malignancies who experienced toxicity after the first cycle of chemotherapy. We assessed the most common symptoms experienced by the patients after the first cycle of chemotherapy and identified the symptoms that led to botheration in the patients receiving chemotherapy.


  Materials and Methods Top


General study details

This was a descriptive, cross-sectional study conducted in the inpatient hemato-oncology unit of a tertiary care hospital in northern India from December 2018 to June 2019. The study was approved by the Institutional Ethics Committee (No. AIIMS/IEC/19/599), of the All India Institute of Medical Sciences, Rishikesh, India; approved on January 19, 2019 [Supplementary Appendix 1]. Written informed consent was obtained from all participants before enrollment in the study. The study was conducted according to the ethical guidelines included in the Declaration of Helsinki and International Committee on Harmonization Good Clinical Practice Guidelines. Anonymity and confidentiality were maintained for all the study participants. As this was a cross-sectional study with no interventions, the study was not registered in a public clinical trials registry. No funding was obtained for this study.



Participants

Patients with hematological malignancies, including leukemia, lymphoma, and myeloma, aged between 18 and 50 years, receiving chemotherapy as the primary treatment modality, and who had received the first cycle of chemotherapy were enrolled in the study. Patients with comorbidities such as diabetes and hypertension were excluded as this could have affected the actual chemotherapy-related side effects experienced by them. Other exclusion criteria were an inability to comprehend the side effects, the presence of any contraindication to chemotherapy and any premorbid side effect.

Variables

Our primary objective was to assess the incidence of the chemotherapy-related side effects experienced during clinical care by patients with cancer after receiving the first cycle of chemotherapy. Our secondary objectives were to identify the most severe symptoms and the most common symptoms that led to botheration in patients receiving chemotherapy.

Study methodology

Data were collected from the participants by interviewing them when they visited our center for planning the second cycle of chemotherapy, about 12–15 days after the administration of the first cycle. Each participant was interviewed only once. The nursing staff personally administered the questionnaire to all participants. The interview lasted approximately 30 min for each participant.

Two data collection tools were used in this study, namely the sociodemographic data sheet and the chemotherapy symptom assessment scale.[17] The sociodemographic data sheet was developed by our research team and included questions regarding the sociodemographic patient profile and baseline information including the name, age, gender, diagnosis, and bed number. The chemotherapy symptom assessment scale is a standardized 21-item questionnaire to assess the chemotherapy side effects.[18] The chemotherapy symptom assessment scale was divided into three phases, namely the presence or absence of symptoms, severity of the symptoms, and how much a symptom annoyed or bothered the patient. At the end of each interview, patients were asked about any other symptom that had not been mentioned in the scale, and the reported symptoms were assessed.

As a part of the face-to-face interview, information was collected regarding the patients' symptoms and their severity and the botheration experienced by the patients during the first week after receiving the first cycle of chemotherapy. Severity was defined as the degree to which a single side effect affected the patient. The symptom severity was categorized as mild, moderate, or severe, based on the standardized scale (pre-decided as per the scale). The level of botheration was categorized as not at all, a little, quite a bit, or very much.

Statistics

The sample size for this study was estimated using the following formula:

n = Z2 (p × q) ÷ c2,[19]

Where n is the sample size; “Z” is the Z value which is 1.96 for the 95% confidence level; “p” is the percentage in the population which is to be taken from a previous study; “q” is (1-p); and “c” is the confidence interval. With Z = 1.96, P = 0.95 (based on the previous study by De Kruif et al.),[20] q = 0.05, and c = 0.01, the sample size of 72 was obtained using the above formula (n = 1.962 [0.95 × 0.05] ÷0.012 = 72). Accounting for an attrition rate of 10%, a total sample size of 100 was determined, which would provide a power of 80% and a 5% level of significance.

Data analysis was done using the Statistical Package for Social Sciences (IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY, USA: IBM Corp.). Simple descriptive statistics were used to analyze the data. For sociodemographic variables, only the frequency and percentages were calculated. For the symptoms and their severity and the botheration experienced by patients, the frequency and percentages were calculated.


  Results Top


Patient and clinical profile

A total of 115 patients were screened for enrollment in the study, of which 15 refused to consent and were therefore excluded. A total of 100 patients were enrolled in the study and the data from these patients were collected and analyzed [Figure 1].
Figure 1: Patient flow diagram

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Majority of the patients were men, age group of 41–50 years and were educated. Most of them had a diagnosis of lymphoma and an Eastern Cooperative Oncology Group performance score of 1 [Table 1].
Table 1: Baseline demographic and disease-related details of the patients enrolled in the study to evaluate the incidence, severity, and botheration caused by chemotherapy side-effects (n=100)

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Responses and outcomes

Incidence of symptoms

The five most common symptoms reported by the patients after the first cycle of chemotherapy were nausea following treatment, feeling weak, feeling unusually tired, feeling anxious or worried, and feeling low or depressed [Table 2].
Table 2: The symptoms experienced by patients with hematolymphoid malignancies after the first cycle of chemotherapy (n=100)

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Symptom severity

The common symptoms that were reported to be of mild severity by the patients after the first cycle of chemotherapy were nausea or vomiting before treatment, problems with the eyes, and feeling low or depressed. The common symptoms that were reported to be of moderate severity included diarrhea, headaches, and feeling anxious or worried. The commonly reported severe symptoms included nausea following treatment, vomiting following treatment, constipation, pain, shortness of breath, temperature change, bleeding, problems with the skin, hair loss, problems with the mouth, change in appetite, weight loss, feeling weak, feeling unusually tired, and difficulty sleeping [Table 3].
Table 3: Severity of symptoms experienced by patients after the first cycle of chemotherapy (n=100)

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Botheration caused by the symptoms

After receiving the first cycle of chemotherapy, the symptoms that did not cause any botheration to the patients included constipation, pain, change in temperature, problems with the skin, problems with the mouth, change in appetite, weight loss/gain, problems with the eyes, feeling weak, and feeling unusually tired. The symptoms that caused a little botheration included nausea or vomiting before treatment, shortness of breath, difficulty sleeping, headaches, feeling anxious, and feeling low or depressed. The only symptom that led to botheration to a considerable extent was hair loss. The symptoms that caused a lot of botheration to the patients with cancer after the first cycle of chemotherapy included nausea following treatment, vomiting following treatment, and diarrhea [Table 4].
Table 4: Botheration experienced by patients after the first cycle of chemotherapy (n=100)

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  Discussion Top


In our study, we observed that the five most common symptoms that patients with hematolymphoid malignancies experienced following the first cycle of chemotherapy were nausea (93%), weakness (92%), tiredness (92%), anxiety (92%), and depression (91%). The most common mild symptoms included feeling depressed (52%), nausea or vomiting before treatment (45%), and problems with the eyes (20%). The most common symptoms of moderate severity were anxiety (50%), depression (35%), and headaches (42%). The five most common severe symptoms included nausea (80%) and vomiting (80%) following treatment, pain (70%), weight changes (69%), and a feeling of weakness (69%). The symptoms that bothered the patients the most were the gastrointestinal symptoms including nausea (60%), vomiting (55%), and diarrhea (25%).

A previous study on symptom assessment in patients with cancer who were receiving chemotherapy reported that nausea (83.3%) and vomiting (78.9%) were the two most common side effects of chemotherapy.[21] In another study conducted to identify patients' concerns and symptoms during chemotherapy, it was observed that 50% of the participants experienced moderate-to-severe degrees of fatigue, alopecia, constipation, and loss of appetite.[17] The results of our study are similar to these results.

The chemotherapy symptom assessment scale is a standardized tool that can easily be administered by nurses or social workers to assess the chemotherapy-related side effects in patients who regularly visit the hospital, both in the inpatient and outpatient settings. Botheration experienced by patients with cancer as a result of chemotherapy-related side effects is an important factor that contributes to a detriment in the quality of life of the patient. Recognizing and addressing these factors is important. Through this study, we have attempted to determine the most important, severe, and botheration-causing symptoms from the patients' point of view as a result of chemotherapy-related side effects. Based on our results, we can infer that from the physicians' point of view, pain, temperature changes, and constipation are often the areas of concern, however, according to patients, these symptoms are the least concerning after chemotherapy. Therefore, as physicians, we should realign our thinking and ask questions from the patients' viewpoint, especially about what symptoms cause them the most botheration; only then can we plan and treat our patients comprehensively.

The limitations of our study were that we only included patients in the age group of 18–50 years. Patients over 50 years old may have experienced more adverse effects than expected, and the results of our study cannot be extrapolated to such patients. Patients with comorbidities were excluded from the study and longitudinal data were not collected as a part of the study. Our study showed that there was a high incidence of certain side effects after the first chemotherapy which were picked up by the questionnaire. The study did not capture whether these patients reported these side effects to the treating physicians post chemotherapy. It is likely that some patients would have consulted the oncologist for these side effects. Hence, the total number of patients who developed side effects minus the patients who had already been treated for side effects would actually have given a better idea of the magnitude of the benefit obtained with this questionnaire.


  Conclusion Top


In patients with hematolymphoid malignancies, gastrointestinal symptoms such as nausea and vomiting were the commonest, severest, and the most bothersome symptoms experienced following the first cycle of chemotherapy. Chemotherapy-related side effects are important, and the physicians must have a thorough knowledge of these. Knowledge about the common side effects of chemotherapy, their severity, and the botheration they cause in patients with cancer will help us plan their symptom management more comprehensively. Moreover, it can also help us plan our health education better by targeting the symptoms that are currently neglected. This will facilitate evidence-based quality care for patients with cancer. We hope that this knowledge will help us better manage the patient symptoms and thereby, improve the quality of life of patients receiving chemotherapy.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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