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Dec 18, 2015 - The. International Psychosocial Oncology Society (IPOS) recommended in- tegrating the psychosocial domain into routine care and measuring.
Japanese Journal of Clinical Oncology, 2016, 46(3) 260–263 doi: 10.1093/jjco/hyv189 Advance Access Publication Date: 18 December 2015 Original Article

Original Article

The validity and reliability of the Korean version of the Cancer-chemotherapy Concerns Rating Scale In Gak Kwon1,2, Myung Sook Cho2, Yun Hee Ham1, Hee Yeon Shin1, Keiko Fujimoto3, Saori Kikuchi3, Bumsuk Lee3, and Kiyoko Kanda3,* 1

Department of Nursing, Samsung Medical Center, Seoul, 2Graduate School of Clinical Nursing Science, Sungkyunkwan University, Seoul, Korea, and 3Graduate School of Health Sciences, Gunma University, Gunma, Japan

*For reprints and all correspondence: Kiyoko Kanda, 3-39-22, Showa-machi, Maebashi, Gunma 371-8514, Japan. E-mail: [email protected] Received 2 September 2015; Accepted 16 November 2015

Abstract Objective: The Cancer-chemotherapy Concerns Rating Scale was developed in Japan for outpatients undergoing chemotherapy, and its validity and reliability have been reported. The purpose of the study was to test the reliability and validity of the Korean version of the Cancer-chemotherapy Concerns Rating Scale. Methods: The questionnaire was filled out by 199 cancer patients, who were currently undergoing outpatient chemotherapy. The data were analyzed using exploratory factor analysis with Promax Rotation to determine the factor construct validity. The reliability of the Cancer-chemotherapy Concerns Rating Scale was investigated by Cronbach’s alpha and the Spearman Brown coefficient. Results: Four factors were obtained and the overall structure was similar to that of the Japanese version; reorganization of daily life, self-existence, disease progress, and social and economic concerns. Cronbach’s alpha for the total scale was 0.91 and the Spearman Brown coefficient was 0.85. Conclusions: We found that the Korean version of the Cancer-chemotherapy Concerns Rating Scale could be clinically useful. It could provide health-care providers with information useful to understand the psychological state of patients undergoing outpatient chemotherapy. Key words: chemotherapy, outpatient, concerns, questionnaire

Introduction Nowadays, chemotherapy treatment is mainly delivered in the outpatient setting. Outpatient chemotherapy has the advantage of allowing easy drug administration, respecting the patient’s wish to avoid hospitalization and providing a familiar facility, which enhances the patient’s physical comfort and psychological well-being (1). Joo et al. (2) reported that patients receiving chemotherapy at home showed higher satisfaction with their treatment than did those treated at a hospital.

However, it is relatively difficult for health-care providers to know the psychological state of outpatients undergoing chemotherapy. The International Psychosocial Oncology Society (IPOS) recommended integrating the psychosocial domain into routine care and measuring distress as the sixth Vital Sign in the IPOS New International Standard of Quality Cancer Care in 2010. In the process of disseminating the standard, ‘busy outpatient clinic’ was mentioned as one of the barriers to be overcome at a the clinical level (3). Taylor et al. (4) suggested the routine use of screening instruments in clinical practice to initiate discussion of psychosocial issues.

© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]

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Jpn J Clin Oncol, 2016, Vol. 46, No. 3 Although the need is well recognized, it is hard to evaluate distress properly because it is a wide-ranging concept. For example, the concept of anxiety is relatively well established. It is, therefore, possible to evaluate the presence and severity of anxiety symptoms using measures of anxiety such as the State Trait Anxiety Inventory (5) or the Hospital Anxiety and Depression Scale (6). On the other hand, distress is seldom defined as a distinct concept (7). It is known that the definition of distress in cancer could encompass depression, anxiety, panic, social isolation and existential and spiritual crisis (8). Concern is also a useful psychological symptom term to assess the concrete factors that encompass distress. Some studies have already reported the importance of assessing the concerns of cancer patients (9,10). However, treatment-related concerns in patients undergoing outpatient chemotherapy have not been adequately discussed. The Cancer-chemotherapy Concerns Rating Scale (CCRS) was developed in Japan for outpatients undergoing chemotherapy, and its validity and reliability have been reported (11). The CCRS consists of 15 Likert-type items formulated into four factors: self-existence, disease progress, reorganization of daily life and social and economic concerns. The CCRS can be filled out in a few minutes and gives detailed information on how health providers need to provide mental support for outpatients. The purpose of the study was to test the reliability and validity of the Korean version of the CCRS.

Methods Participants The study was conducted in an ambulatory treatment center at a general hospital in Seoul between April and May 2014. A convenient sampling method was used to recruit patients. Patients, who were undergoing outpatient chemotherapy, agreed to fill out the questionnaire after listening to an explanation of its objectives. The questionnaire was distributed to 200 potential participants and filled out by 199 cancer patients. Patients undergoing radiation therapy simultaneously were excluded in order to focus on the influence of chemotherapy. Moreover, patients who were presented with an Eastern Cooperative Oncology Group Performance Status score >2 were also excluded in accordance with the treatment protocol. The study was approved by the Samsung Medical Center Institutional Review Board and informed consent was obtained prior to the study.

Instruments The study used the Korean version of the CCRS. The CCRS was translated into Korean by a panel consisting of three oncology nurses and a bilingual nurse, and back translated into Japanese by a Korean person different from the original translators. This process was repeated until the back translation expressed a similar sense to the original version. Some words and phrases were adjusted to facilitate patients’ understanding. Patients were asked to respond to each item with a score of 4, where 1 = not at all, 2 = a little bit, 3 = quite a bit and 4 = very much. A higher score indicates a high level of concern. Several demographic questions were collected such as gender, age, family living together, etc. The Function Assessment of Cancer Therapy-General (FACT-G) was used to assess health related quality of life, and the Distress thermometer was used to assess psychological morbidity.

Reliability and validity The sum of mean and standard deviation was measured to evaluate ceiling effects (mean + SD > 4.0), and item-total correlation was measured to verify the correlation of each item’s score with the sum of

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other item’s scores. Moreover, exploratory factor analysis (Maximum Likelihood Analysis with Promax Rotation) was also conducted. The reliability of the CCRS was based on internal consistency by Cronbach’s alpha and Spearman Brown coefficient. Temporal stability using the test–retest method was not measured because concerns are easily changed by the influence of physical or mental conditions. Validity was tested using criterion-based validity (vs. FACT-G and Distress) and construct validity (Maximum Likelihood Analysis with Promax Rotation). Statistical analysis was conducted by the Statistical Package for Social Sciences version 22.0 J (IBM, New York, USA). P values < 0.05 were considered significant. Table 1. Demographic and clinical characteristics of the patients Characteristics Gender Male Female Age ≤39 40–59 ≥60 Family living together Spouse + child(ren) Spouse Child(ren) Alone Others State of employment Employed Unemployed Educational level Elementary school Middle school High school Baccalaureate degree and over Yearly income (KRW)a 100 000 000 Primary tumor site Hematologic Lung Digestive Breast Other Disease stage Local Metastatic Unknown Experience of radiation Yes No Global health state Good Able to walk Require assistance with walking Unable to walk Conferee Inside the family Outside the family Inside+outside the family Nobody a

KRW, Korean won (1000 KRW ≈ 100 Japanese yen).

n (%)

117 (58.7) 82 (41.2) 30 (15.0) 104 (52.2) 65 (32.6) 99 (49.7) 52 (26.1) 19 (9.5) 8 (4.0) 21 (10.5) 114 (57.2) 82 (41.2) 6 (3.0) 24 (12.0) 91 (45.7) 77 (38.6) 152 (76.3) 34 (17.0) 6 (3.0) 18 (9.0) 40 (20.1) 62 (31.1) 67 (33.6) 9 (4.5) 66 (33.1) 111 (55.7) 22 (11.0) 66 (33.1) 130 (65.3) 38 (19.1) 133 (66.8) 18 (9.0) 9 (4.5) 66 (33.1) 28 (14.0) 85 (42.7) 20 (10.0)

The Korean version of CCRS

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Table 2. Rotated factor analysis of the Korean version of the CCRS Factor 1: reorganization of daily life

Factor 2: self-existence

Item no.

Loading

Item no.

Item 3 Item 4 Item 5 Item 6 Item 7 % Variance Cumulative % Commonalities Cronbach’ alpha

0.64 0.63 0.79 0.87 0.42 21.27 21.27 >0.35 0.85

Item 9 Item 10 Item 11 Item 12 Item 13 28.79 50.06 >0.57 Cronbach’ alpha

Factor 3: disease progress

Factor 4: social and economic concerns

Loading

Item no.

Loading

Item no.

Loading

0.90 0.91 0.70 0.65 0.45

Item 1 Item 2

1.07 0.49

Item 13 Item 15

0.42 0.76

0.74

2.77 59.89 >0.48 Cronbach’ alpha

0.62

0.88

Table 3. The 15 items of the Cancer-chemotherapy Concerns Rating Scale in the Japanese and Korean versions Not A little Quite Very at all bit a bit much 1 2 3

4 5 6 7

8 9 10 11 12 13 14

15

I cannot get concerns out of my mind I am concerned that relapse or metastasis will happen My physical/mental strength were decreased because of chemotherapy I am not able to do my self-care activities by myself I could not maintain my life rhythm My work, work at home or study is not fulfilling I restrict my daily life because of concerns about the disease condition My family is concerned about me and restricts my life I feel alienated from society It is hard to keep feeling myself I want to rely on something I lost a human relationship I am concerned about my family while I undergo chemotherapy I am concerned that I could not play my role while undergoing chemotherapy I am concerned that financial problem will happen while I undergo chemotherapy

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1 1 1 1 1

2 2 2 2 2

3 3 3 3 3

4 4 4 4 4

1

2

3

4

1

2

3

4

Results The demographic and clinical characteristics of the patients are shown in Table 1. The mean age was 53.0 years (SD = 11.5). They were predominantly living together with a spouse and/or child(ren) (85.4%, 170/199). Almost all of them were graduated from high school or above (84.4%). There was no significant ceiling effect (mean + SD ≤ 3.98) and all items showed a high degree of item-total correlation (0.48 ≤ r ≤ 0.81, P < 0.01). As a result of the exploratory factor analysis, four factors were obtained and the overall structure was similar to the Japanese version

7.06 57.12 >0.42 Cronbach’ alpha

(Table 2). Each item on the disease progress and self-existence of the Japanese version (nos 3 and 7) were loaded into Factor 1. One item on the social and economic concerns (no. 13) was loaded into Factors 2 and 4. Two items (nos 8 and 14) failed to load meaningfully on any factor in the study (Table 3).

Reliability Cronbach’s alpha for the total scale was 0.91 and the values for the subscales were 0.85 (reorganization of daily life), 0.88 (self-existence), 0.74 (disease progress) and 0.62 (social and economic concerns). Moreover, the Spearman Brown coefficient was 0.85, indicating good internal consistency of reliability.

Validity In the concurrent validity, moderate correlations were observed between FACT-G (r = −0.64, P < 0.001) and Distress (r = 0.67, P < 0.001). In the construct validity, the factor construct of the Korean version of CCRS scale is similar to that of the Japanese version: reorganization of daily life, self-existence, disease progress and social and economic concerns. Commonalities exceeded 0.4 in 13 of the 15 items, indicating that there is enough commonality to justify comprising factors. The four factors accounted for 59.9% of the variance (Table 2).

Discussion We found that the Korean version of the CCRS showed adequate reliability and validity when measuring concerns of cancer patients undergoing outpatient chemotherapy in Korea. Cronbach’s alpha for the total scale was 0.91 and the Spearman Brown coefficient was 0.85, which indicates high reliability. The validity was confirmed by correlation with FACT-G (r = −0.64, P < 0.001) and Distress (r = 0.67, P < 0.001). Therefore, the Korean version of the CCRS is sufficiently reliable and valid for practical use. Four factors were obtained and the overall structure was similar to that of the Japanese version. Especially, Factor 2 (Self-existence) accounted for 28.8% of the variance. This high factor contribution may imply that maintaining a sense of self-existence in the process of chemotherapy treatment is essential. However, two items on factor loading were problematic; Item 8 (My family is concerned about me and restricts my life) and Item 14 (I am concerned that I could not play my role while undergoing chemotherapy). Our understanding is that this may be due to the following translation issue. The translated Korean terms for ‘life’ and ‘role’ ( pronounced ‘Saenghwal’ and

Jpn J Clin Oncol, 2016, Vol. 46, No. 3 ‘Yeokhal’) have a broader meaning than in Japanese. This caused participants confusion in understanding the Korean terms for ‘life’ and ‘role’. This understanding is supported by item seven. The term ‘life’ in Item 7 (I restrict my daily life because of concerns about my disease condition) was translated into ‘daily life’ in the Korean version to clarify the meaning and loaded into Factor 1. We think the Korean terms for ‘life’ and ‘role’ should have been translated into clearer Korean terms. On the factor loading, Item 13 (I am concerned about my family while undergoing chemotherapy; Social and economic concerns subscale on the Japanese version) was loaded onto Factor 2 (Selfexistence) and Factor 4 (Social and economic concerns). The legacy of Confucianism remains a fundamental part of Korean society and culture. In Confucianism a family member has as much value as oneself. Therefore, concern about a family member is considered as a concern about oneself. Based on this Confucian value, Korean patients may perceive family aspects equally with self-existence. It is interesting that Item 3 (My physical/mental strength were decreased because of chemotherapy; Disease progress subscale on the Japanese version) and Item 7 (I restrict my daily life because of concerns about my disease condition; Self-existence subscale on the Japanese version) were loaded onto Factor 1 (Reorganization of daily life). Korean patients have a tendency to reorganize their daily life based on their concerns about physical/mental strength and disease condition. The CCRS had the following strengths. Although the Distress thermometer is a good scale to measure the level of stress (12), it is difficult for health-care providers to find appropriate interventions that provides stress relief. Compared with that, the CCRS better provides the information on which subscale causes the concerns. Therefore, health-care providers could find an appropriate intervention using the results of the CCRS. In the present study, patient stress showed the positive correlation with all subscales; Reorganization of daily life (rs = 0.55), Self-existence (rs = 0.62), Disease progress (rs = 0.47) and Social and economic concerns (rs = 0.46) (P < 0.01). In fact, some patients showed large differences between factors. The other strength is that the CCRS could be completed within a few minutes. It could be recommended for patients with heavy physical and mental fatigue in an outpatient setting. Based on the study, we conclude that the Korean version of the CCRS could be clinically useful. It could provide health-care providers with useful information to understand the psychological state of patients undergoing outpatient chemotherapy.

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Funding This work was supported by JSPS KAKENHI grant number 24390489.

Conflict of interest statement None declared.

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