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Original Research

Cross-cultural Adaptation and Psychometric Evaluation of the Persian Version of the Leuven Questionnaire for Patient Self-care During Chemotherapy

Nejat, Nazi PhD; Rafiei, Fatemeh PhD (Stu); Ebrahimabadi, Maryam MSN

Author Information
Cancer Care Research Online: April 2021 - Volume 1 - Issue 2 - p e0006
doi: 10.1097/CR9.0000000000000006
  • Open

Abstract

Introduction

One of the most important diseases and the leading cause of death second to cardiovascular diseases is cancer; every year more than 10 million people are diagnosed with a variety of cancers.1 In Iran, the third leading cause of death after cardiovascular diseases and accidents is cancer.2 There are a variety of treatments, depending on the type of cancer and patient’s conditions, such as surgery, radiotherapy, immunotherapy, and chemotherapy.3 One of the most common cancer treatments is chemotherapy, which can be used either alone or in combination with each other or other therapies.4,5

In chemotherapy, antineoplastic drugs are used to stop the progression of or eliminate cancer cells; however, healthy cells are also destroyed.6 Numerous side effects result, including diarrhea, low-blood pressure, drowsiness, constipation, nausea and vomiting, hair loss, fatigue, muscle aches, weight changes, skin problems, among others.7–9 Chemotherapy is typically administered at outpatient settings.6,10,11 Limiting factors to clinicians offering potential supportive care include the physically cramped space in outpatient settings and the business of clinical care nurses and physicians.11 Patients can be left to their own resources to deal with the adverse effects of chemotherapy.12

Self-care is behavior initiated or performed by individuals on their own to foster their health and safety.13 Positive outcomes of self-care behaviors include reduction in morbidity associated with illness, increased use of health resources, more effective coping strategies, enhanced role performance, increased independence in performance of daily living activities, and enhanced self-esteem and well-being.14

A careful assessment of health behaviors and lifestyles is vital15 for the additional reasons of helping to design and develop educational and supportive programs, and to document patients’ self-reported strategies that they implement for symptom management specific to chemotherapy side-effects.16 To evaluate the effectiveness of self-care guidance provided to patients, certain instruments, and scales for assessment of self-care have been developed.17

Questionnaires can document patients’ knowledge, beliefs, attitudes, and behavior18,19 and especially if questionnaires are in the native language.20 In the process of instrumentation, cultural background differences must be considered along with the instrument’s translation. These differences help to ensure that the instrument is congruent with the culture of the target community.21 In addition, an instrument should be easily applied to the target population.22

In our Iranian society, the concept of self-care and related factors in patients with cancer has been less addressed.23 Patient Self-care during Chemotherapy (L-PaSC) is a comprehensive and multidimensional questionnaire developed by Coolbrandt et al.24 The L-PaSC has not been translated or localized, and its reliability and validity in other languages have not been assessed to this point. To the best of our knowledge, there is no reported Persian version of the L-PaSC. The aim of this study was to translate and perform a psychometric assessment of the L-PaSC into Persian.

Methods

Study Design and Patients

In this cross-sectional study conducted at a large teaching hospital, the Ayatollah-Khansari Cancer Hospital, eligible patients were adults with cancer undergoing chemotherapy. The inclusion criteria were: a confirmed diagnosis of cancer from an oncologist, receiving chemotherapy treatment, aware of the diagnosis, had no hearing and speech impairments, had access to a home or cell phone, had no mental illness, and were between 18 and 80 years of age. The exclusion criteria were: death during the study or reluctance to stay in the study. Written informed consent was obtained from all individual participants. The study was performed in accordance with the standards as outlined in the Declaration of Helsinki.25 This study was registered in the Ethics and Research Center of Arak University of Medical Sciences with the code of ethics (IR.ARAKMU.REC.1396.159).

Measurement

The L-PaSC was developed to assess patient self-care during chemotherapy by Coolbrandt et al.24 The L-PaSC has 12 main questions Q1–Q12) with 7 and 5 questions for Q1 and Q2, respectively. Q1 assessed adherence to self-care recommendations for everyday life. The responses for each item range from 1, “Never,” to 5, “Always,” on a 5-point Likert-type scale. Q2 is about symptom self-management and has multiple-choice responses (patients can have single select or multi-select answer options). Q3, 4, and 5 address adherence to oral chemotherapy, supportive medication, and symptom-relieving self-care advice; their responses are indicated using visual analogue scales (VAS) from 0% to 100%. Q6 through Q10 are about symptom self-management and also have multiple-choice responses. Q11 and 12 are about symptom (tiredness and pain) self-management. If patients indicate experiencing tiredness and pain, they are then asked to identify what they do to stop these (as assessed with multiple-choice questions).

Questions are not counted in the total score if the question was answered with “not applicable,” meaning that the patient had not experienced that symptom. The total score is counted as a relative score and is expressed with a percentage. The content validity of the original questionnaire was reported to be excellent (CVI = 0.78–1.00). The reliability of the original scale was assessed by means of internal consistency, with Cronbach’s alpha coefficient of 0.76.24

Cross-cultural Adaptation of the L-PaSC

The developer of the L-PaSC (Coolbrandt) gave written permission for validation and use of the instrument in Iran before the start of the cross-cultural adaptation process. The cross-cultural adaptation process was conducted according to guidelines for the process of cross-cultural adaptation of self-report measures: translation, synthesis, back translation, synthesis of back translation, expert committee review of the translated version, and pretesting.26 Please see Figure 1.

F1
Figure 1.:
Flow chart depicting the linguistic and cultural adaption process of L-PaSC-P.

We conducted a forward-backward procedure to translate the English version of the L-PaSC into Persian, which is the most common method of preparing questionnaires for cross-cultural application.27 During the cross-cultural adaptation process, no changes were recommended to the questions or response options. The expert committee, composed of 1 oncologist, 2 oncology nurses, an epidemiologist, and translators (2 Iranian translators that knew both the Farsi and English languages) prepared 2 separate translations of the English version of the L-PaSC questionnaire. Subsequently, 2 English language experts that knew the Farsi language assessed the translated version of the Persian L-PaSC. The preliminary adapted version of the L-PaSC-P was used for pretesting.

Pretesting Phase

The mean time to completion of the L-PaSC-P was 10 minutes by 10 patients. No modifications were required after pretesting; therefore, the preliminary adapted version was kept unchanged as the final Iranian version, which was given the acronym of L-PaSC-P.

Psychometric Properties of the L-PaSC-P

Validity

Face validity was assessed by 10 patients and 10 experts.28 The L-PaSC-P was administered to 10 patients with cancer undergoing chemotherapy; the patients shared their opinions with the researchers regarding the comprehensibility and possible misunderstandings associated with the questions. After that, the L-PaSC-P was given to 5 nurse faculty experts to assess the concept and the correctness of the items; their opinions were then applied. Content validity was determined by 10 nurse faculty experts.

Reliability

Test-retest and internal consistency (Cronbach’s alpha coefficient) were estimated, respectively. The L-PaSC-P was completed by patients and the Cronbach’s alpha coefficients was calculated for each item as well as for the whole the questionnaire. The Cronbach’s alpha values >0.70 was considered satisfactory reliability. The questionnaire was completed by 10 patients twice in 1 week. The first administration was done face to face and the second during a telephone call. Spearman correlation coefficient and intraclass correlation coefficient (ICC) were determined, with an index higher than 0.8% considered as acceptable.19

The Persian L-PaSC was completed by 154 patients with cancer undergoing chemotherapy in a private room. On average, respondents took 10.3 ± 5 minutes to complete the L-PaSC-P.

Data Analysis

Continuous variables were expressed as means ± SD. P values <.05 were considered statistically significant. Descriptive statistical analyses were performed to analyze the demographic characteristics of patients. The validity of the L-PaSC-P was estimated using both CVR and CVI. The reliability of this instrument was estimated using Cronbach’s alpha coefficients and test-retest stability technique. Data analysis was performed by the Statistical Package for the Social Sciences (SPSS) software version 16.0 (SPSS Inc., Chicago, IL).

Results

Of the 160 patients invited to participate, 6 were excluded due to screening failure, 3 declined to participate, and 3 did not fully complete the L-PaSC-P (Table 1). The final sample included 154 patients with cancer (Figure 2), 30 of whom took part in the test-retest study. Both the final sample and the test-retest sample were selected by convenience sampling method.

Table 1. - Persian Version of the Leuven questionnaire for Patient Self-care during Chemotherapy (L-PaSC-P)
Q1: Self-care measures a-Drinking 1.5 L/d
b-Oral hygiene
c-Careful handling of excreta
d-Avoiding sick, contagious people
e-Taking body temperature when feeling ill
f-Taking medication without consulting a doctor
g-Taking measures to avoid pregnancy
Q2: Reaction to the situation a-Sudden shortness of breath with the least effort
b-Fever )38.5°C(
c-Three episodes of diarrhea in 1 d
d-Five episodes of vomiting and impossible fluid intake
e-Tingling in the finger tips
Q3: Correct intake of oral chemotherapy
Q4: Correct intake of supportive medication
Q5: Correct performance of self-care advice
Q6: Self-management of oral mucositis
Q7: Self-management of skin problems
Q8: Self-management of nausea
Q9: Self-management of constipation
Q10: Self-management of diarrhea
Q11: Self-management of tiredness
Q12: Self-management of pain

The mean (±SD) age and time from diagnosis were 52.79 (±15.79) and 2.42 (±2.64) years, respectively. The mean (±SD) course of chemotherapy was 8.24 (±10.23) courses. The demographic characteristics of study participants are in Table 2.

Table 2. - Demographic Characteristics of the Participants
N (%)
Gender Males 93 (60.4)
Females 61 (39.6)
Marital status Single 17 (11)
Married 132 (85.7)
Widow 5 (3.2)
Educational level Low literacy 47 (30.5)
Elementary 38 (24.7)
Guidance 23 (14.9)
High school 26 (16.9)
Academic 20 (13)
Type of cancer Liver 9 (5.8)
Breast 16 (10.4)
CML 7 (4.5)
Lymphomas 22 (14.3)
CRC 26 (16.9)
ALL 8 (5.2)
Renal 4 (2.6)
Lung 20 (13)
Oesophagus 5 (3.2)
Gastric 11 (7.1)
Prostate 4 (2.6)
Bone marrow 5 (3.2)
AML 1 (0.6)
Sarcoma 8 (5.2)
Thyroid 1 (0.6)
Brain 1 (0.6)
Pancreatic 6 (3.9)
Abbreviations: ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; CML, chronic myelogenous leukemia; CRC, colorectal cancer.

The total score of the L-PaSC-P, standardized on a scale of 0 to 100, was 42.59 ± 14%, indicating less than 50% of the participants met their self-care expectations.

Validity Testing

Quantitative face validity was calculated by impact score. The mean impact score was 1.75 and all the items had an impact score ≥1.5, indicating face validity was achieved.

The CVI mean score was 0.98 with item scores ranging from 0.82 to 1.00. The average of the CVI components including relevancy, simplicity, and celerity was estimated to be 0.94, 0.85, and 0.87, respectively. According to Lawshe’s Scale, an acceptable CVR value for 10 specialists is 0.6229 (Table 3).

Table 3. - The Content Validity Ratio and Content Validity Index for Each Item of Measure of L-PaSC
Questions Impact score (Face Validity) CVI CVR
relevancy simplicity celerity Total
Q1a: Drinking 1.5 L/d 1.85 1 0.82 0.82 1 0.81
Q1b: Oral hygiene 1.85 1 0.9 1 1 1
Q1c: Careful handling of excreta 1.90 0.9 0.82 0.82 1 0.81
Q1d: Avoiding sick, contagious people 1.70 1 0.9 0.82 1 0.81
Q1e:Taking body temperature when feeling ill 1.95 1 0.82 0.82 1 1
Q1f: Taking medication without consulting a doctor 1.70 0.82 0.82 0.82 0.9 0.82
Q1g: Taking measures to avoid pregnancy 1.75 1 0.9 0.82 1 0.81
Q2a: Sudden shortness of breath with the least effort 1.70 0.82 0.82 0.9 1 0.82
Q2b: Fever (38.5°C) 1.65 1 0.82 0.9 1 1
Q2c: Three episodes of diarrhea in 1 d 1.70 1 0.82 0.9 1 0.81
Q2d: Five episodes of vomiting and impossible fluid intake 1.75 0.9 0.82 0.82 1 0.82
Q2e: Tingling in the finger tips 1.65 0.8 1 1 0.82 0.9
Q3: Correct intake of oral chemotherapy 1.85 0.82 0.82 0.82 1 0.81
Q4: Correct intake of supportive medication 1.80 0.82 0.9 0.82 0.9 0.81
Q5: Correct performance of self-care advice 1.70 1 0.9 0.9 1 1
Q6: Self-management of oral mucositis 1.75 1 0.82 0.82 1 1
Q7: Self-management of skin problems 1.60 1 0.82 0.82 1 1
Q8: Self-management of nausea 1.60 1 0.82 0.82 1 1
Q9: Self-management of constipation 1.75 1 0.82 0.9 1 1
Q10: Self-management of diarrhea 1.75 1 0.9 0.9 1 0.81
Q11: Self-management of tiredness 1.80 1 0.9 0.9 1 1
Q12: Self-management of pain 1.75 0.9 0.82 1 1 0.81
Mean 1.75 0.94 0.85 0.87 0.98 0.89
Abbreviations: CVI, Content Validity Index; CVR, Content Validity Ratio; L-PaSC, Leuven Questionnaire for Patient Self-care During Chemotherapy.

Reliability Testing

Table 4 shows the results of the test-retest (Spearman correlation coefficient and ICC) and Cronbach’s alpha of each question and the whole questionnaire. The Spearman correlation coefficient of the questions with each other ranged from 0.41 to 1.00, and the Spearman correlation coefficient for total score was 0.94. The ICC coefficient of higher than 0.8 shows good reliability. Although the ICC of the questions ranged from 0.51 to 1.00, the total ICC was higher (0.96), and showed strong reliability. The internal consistency by Cronbach’s alpha was calculated from 0.51 to 1.00, and the Cronbach’s alpha for the total score was 0.96.

Table 4. - Reliability Measures of Measure of Processes of L-PaSC
Questions First test Second test Wilcoxon test Spearman Correlation Coefficient ICC P Cronbach’s alpha
Mean (SD) Mean (SD) P Z Test means 1 test
Q1a: Drinking 1.5 L/d 0.38 (0.49) 0.35 (0.48) .083 −1.73 0.93 0.96 0.93 .0001 0.96
Q1b: Oral hygiene 0.38 (0.49) 0.37 (0.48) .564 −0.58 0.93 0.96 0.93 .0001 0.96
Qc: Careful handling of excreta 0.58 (0.49) 0.58 (0.49) .999 0.00 1 1 1 .0001 1
Q1d: Avoiding sick, contagious people 0.64 (0.48) 0.64 (0.48) .999 0.00 1 1 1 .0001 1
Q1e:Taking body temperature when feeling ill 0.18 (0.39) 0.17 (0.38) .317 −1.00 0.96 0.98 0.96 .0001 0.98
Q1f: Taking medication without consulting a doctor 0.54 (0.5) 0.54 (0.5) .999 0.00 0.96 0.98 0.96 .0001 0.98
Q1g:Taking measures to avoid pregnancy 0.05 (0.23) 0.04 (0.2) .317 −1.00 0.89 0.94 0.88 .0001 0.94
Q2a: Sudden shortness of breath with the least effort 0.26 (0.44) 0.28 (0.45) .317 −1.00 0.89 0.94 0.89 .0001 0.94
Q2b: Fever)38.5 ˚C( 0.48 (0.5) 0.61 (0.49) .06 −1.89 0.78 0.88 0.78 .0001 0.88
Q2c: Three episodes of diarrhea in 1 d 0.63 (0.48) 0.45 (0.5) .157 −1.41 0.95 0.98 0.95 .0001 0.98
Q2d: Five episodes of vomiting and impossible fluid intake 0.65 (0.47) 0.63 (0.48) .157 −1.41 0.95 0.98 0.95 .0001 0.98
Q2e: Tingling in the finger tips 0.88 (0.31) 0.9 (0.3) .317 −1.00 0.94 0.97 0.94 .0001 0.97
Q3: Correct intake of oral chemotherapy 0.28 (0.45) 0.27 (0.45) .320 −1.00 0.97 0.99 0.97 .0001 0.99
Q4: Correct intake of supportive medication 0.3 (0.46) 0.31 (0.46) .317 −1.00 0.97 0.99 0.97 .0001 0.99
Q5: Correct performance of self-care advice 0.16 (0.37) 0.7 (0.38) .564 −0.577 0.88 0.94 0.88 .0001 0.94
Q6: Self-management of oral mucositis 0.2 (0.4) 0.21 (0.41) .655 −0.447 0.83 0.91 0.83 .0001 0.91
Q7: Self-management of skin problems 0.46 (0.5) 0.43 (0.49) .180 −1.342 0.89 0.94 0.89 .0001 0.94
Q8: Self-management of nausea 0.4 (0.49) 0.32 (0.46) .008 −2.64 0.84 0.92 0.84 .0001 0.92
Q9: Self-management of constipation 0.4 (0.49) 0.42 (0.49) .480 −0.707 0.82 0.90 0.82 .0001 0.90
Q10: Self-management of diarrhea 0.26 (0.44) 0.23 (0.42) .083 −1.732 0.92 0.96 0.91 .0001 0.96
Q11: Self-management of tiredness 0.07 (0.26) 0.11 (0.31) .317 −1.00 0.42 0.59 0.42 .0001 0.59
Q12: Self-management of pain 0.32 (0.46) 0.36 (0.48) .317 −1.00 0.61 0.76 0.61 .0001 0.76
Total 8.62 (2.8) 8.45 (2.84) .125 −1.53 0.94 0.97 0.93 .0001 0.97

Table 5 shows the score mean (SD) obtained for each question. Total score mean (SD) of L-PaSC-P was 9.37 (3.19).

Table 5. - Score Mean (SD) Questions for Participations
Questions Mean SD
Q1a: Drinking 1.5 L/d 0.38 0.49
Q1b: Oral hygiene 0.42 0.50
Qc: Careful handling of excreta 0.63 0.48
Q1d: Avoiding sick, contagious people 0.73 0.45
Q1e:Taking body temperature when feeling ill 0.15 0.36
Q1f: Taking medication without consulting a doctor 0.62 0.49
Q1g:Taking measures to avoid pregnancy 0.06 0.24
Q2a: Sudden shortness of breath with the least effort 0.30 0.46
Q2b: Fever(38.5°C) 0.50 0.50
Q2c: Three episodes of diarrhea in 1 d 0.60 0.49
Q2d: Five episodes of vomiting and impossible fluid intake 0.60 0.49
Q2e: Tingling in the finger tips 0.75 0.44
Q3: Correct intake of oral chemotherapy 0.2922 0.46
Q4: Correct intake of supportive medication 0.36 0.48
Q5: Correct performance of self-care advice 0.25 0.44
Q6: Self-management of oral mucositis 0.29 0.45
Q7: Self-management of skin problems 0.40 0.50
Q8: Self-management of nausea 0.49 0.50
Q9: Self-management of constipation 0.45 0.50
Q10: Self-management of diarrhea 0.25 0.44
Q11: Self-management of tiredness 0.38 0.49
Q12: Self-management of pain 0.49 0.50
Sum 9.37 3.19

Discussion

This was the first Iranian study to conduct a cross-cultural adaptation and psychometric testing of the L-PaSC, a scale for the assessment of self-care by patients with cancer undergoing chemotherapy. The equivalence in translation and culture adaptation was rigorously maintained. Patients and expert health care professionals formally assessed the L-PaSC and indicated there was no need to modify any terms or expressions to facilitate understanding of the content.

In healthy and sick individuals, self-care activities are part of daily activities and include all activities that help health and prevent diseases.30 The L-PaSC reflects to what extent the respondent performs essential self-care activities during chemotherapy. Our findings indicate the very acceptable validity and reliability of the L-PaSC-P. The quantitative face validity findings indicated that experts believed that all of the items were necessary. The CVI average was 0.98, the very same as the original version.31 The CVR average was 0.89 and for all items was higher than Lawshe’s Scale so the items proved to be acceptable.32

The accuracy of the measuring tool is assessed by reliability and refers to the stability of measuring the traits or structures in a tool.33 In the present study, the ICC and Cronbach’s alpha coefficients for the total score were 0.96 and 0.96, respectively, exceeding the value noted in the internal validity testing of the original questionnaire (Cronbach’s alpha = 0.76).24

Study Limitations

In the test-retest, the first time point of questionnaire completion was done in the presence of the participants, but in the second time point, data were collected via cell phone because the participants were not in the clinic and thus not accessible for a face to face administration of the L-PaSC-P; this method confound might affect the participants’ responses somewhat. The L-PaSC-P is intended to be a self-administered questionnaire; we were unable to verify the accuracy of responses by the patients. Because of the diversity of diagnoses in our study sample, we suggest future research be done examining self-care strategies in a more homogenous set of samples.

Implications for Nursing Practice and Research

The L-PaSC-P if completed by adult oncology patients in advance of being seen by oncology nurses and physicians could directly inform these clinicians as to the actual self-care status of the patients. Such knowledge could be used by the clinicians to give encouragement to the patients to continue with their self-care activities and to enhance their current knowledge about those and other self-care activities. The L-PaSC-P may also be used in research studies where effects and outcomes of self-care activities could be better determined by this psychometrically strong measure.

F2
Figure 2.:
XXXX.

Conclusion

To assess the self-care status of patients with cancer undergoing chemotherapy, the Persian version of the Leuven questionnaire is a reliable and valid instrument. It could be used as an acceptable and standard instrument in all health, clinical and rehabilitation centers to improve the level of self-care in Iran.

Acknowledgments

The researchers grateful the experts and patients who actively participated in the study. We would also like to thank the Student Research Committee and Office of the Vice Chancellor for Research, Arak University of Medical Sciences (IR).

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Keywords:

cancer survivors; self-management planning; validity; reliability; self-efficacy

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