Qual Life Res DOI 10.1007/s11136-014-0661-4

Measuring individual quality of life in patients receiving radiation therapy: the SEIQoL-Questionnaire Gerhild Becker • Constanze S. Merk Cornelia Meffert • Felix Momm



Accepted: 24 February 2014  Springer International Publishing Switzerland 2014

Abstract Purpose Quality of life (QoL) is one of the most important outcomes in cancer care. Although a number of instruments to measure health-related QoL (HRQoL) exist, there are few suitable instruments to measure individual QoL. The best established instrument is the Schedule for the Evaluation of Individual Quality of Life (SEIQoL). The disadvantage of this questionnaire is its use of semistructured interviews, which are very time-consuming. The purpose of our study was to transform the SEIQoL into an economical instrument that can be used in clinical trials with large samples. Methods We developed the SEIQoL-Questionnaire (SEIQoL-Q) on the basis of the SEIQoL-Direct Weighting (SEIQoL-DW) by transforming the interview guide into a written questionnaire. Patients (N = 1,108) in all three phases of radiation treatment (first consultation, ongoing irradiation, and aftercare) were asked to complete the SEIQoL-Q and the European Organization for Research and Treatment of Cancer QLQ-C30.

Gerhild Becker and Constanze S. Merk have contributed equally to this work. G. Becker  C. Meffert (&) Palliative Care Research Group, Department of Palliative Medicine, University Medical Center Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany e-mail: [email protected] C. S. Merk Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany F. Momm Department of Radiation Oncology, Ortenau Medical Center Offenburg-Gengenbach, Offenburg, Germany

Results While the average HRQoL measured by the QLQ-C30 was 55.6, the average SEIQoL-Q index was 59.6. The most important life domain was ‘‘physical health,’’ followed by ‘‘emotional well-being’’ and ‘‘family.’’ Patients attributed the highest level of satisfaction to ‘‘home/housing,’’ followed by ‘‘family’’ and ‘‘partnership.’’ Male patients were shown to have a significantly better QoL than females. The SEIQoL-Q index correlates moderately with the QLQ-C30 functioning scale ‘‘global quality of life’’ [r = .42 (p \ .001)]. Conclusions According to our findings, the SEIQoL-Q appears to be a feasible and economical instrument for use in quantitative research among cancer patients in different stages of their disease. Keywords Quality of life  Radiotherapy  Advanced diseases  Palliative care  Cancer  Oncology

Introduction Cancer produces multiple distressing symptoms that affect not only functioning but also quality of life (QoL), especially for patients in an advanced stage of the disease [1]. Achievements in modern medicine have increased the possibility of prolonging life among patients with incurable diseases, and one can expect the number of patients in need of end-of-life care to rise [2]. In addition to traditional outcome parameters such as survival or local tumor control, it is becoming more and more necessary to investigate QoL in clinical trials. As health care shifts from a biomedical to a biopsychosocial paradigm [3], a majority of clinical research scientists insists that QoL is a valid and important aspect of a patient’s condition [4]. However, there is presently neither a consensus on how to define QoL

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in patients with progressive incurable diseases nor how to measure it [5]. We dispose of a number of instruments to measure health-related QoL (HRQoL) for curatively treated cancer patients, such as the ‘‘European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30’’ [6] or the ‘‘Functional Assessment of Chronic Illness Therapy (FACIT)’’ [7]. Yet, there are few suitable instruments to measure individual QoL despite its importance in cancer care and, above all, in palliative care [8, 9]. The best established instrument to evaluate individual QoL is the Schedule for the Evaluation of Individual Quality of Life (SEIQoL) [10] which uses an individualized approach to measure each patient’s unique perspective on QoL. Patients can choose, rate, and weight five domains that they consider important, such as ‘‘family,’’ ‘‘health,’’ or ‘‘social life/other relations’’ [11]. However, the disadvantage of this instrument is its use of semi-structured interviews, which are very time-consuming. When working with the large numbers of patients, this type of instrument—even in its shortened form [SEIQoL-Direct Weighting (SEIQoL-DW)]—is not practical for day-to-day clinical work in a (radiation) oncology or palliative care unit where cancer patients are usually treated. For these reasons, the purpose of our study was to transform the SEIQoL into an economical instrument that can be used in daily clinical work as well as in clinical trials with large samples. Furthermore, our investigation focused on the following questions: (1) How good is the individual and the health-related QoL in patients receiving radiotherapy (measured by the SEIQoL-Q and the QLQC30, respectively)? (2) How important are the life domains measured by the SEIQoL-Q for patients receiving radiotherapy, and how satisfied are they with each of these domains? (3) Do variables such as sex, age, or diagnosis influence individual QoL? (4) What are the correlations between the SEIQoL-Q and the QLQ C30 scales?

Methods Design A cross-sectional study was conducted for a period of four months (September–December 2010). Sample and recruitment Patients were recruited in the Department of Radiation Oncology at the University Medical Center Freiburg, Germany. Patients in all three phases of radiation treatment (first consultation, ongoing irradiation, and aftercare) were eligible for consecutive inclusion in our study. Patients with strong mental or physical restrictions who had a

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considerable risk of being overstrained by filling in the questionnaire were not included. Patients were asked to complete the SEIQoL-Q and the QLQ-C30. Physicians collected patients’ sociodemographic data and made main diagnoses. We aimed at surveying at least 1,000 patients in order to gain a representative sample of all patients in contact with the radiotherapy department. Ethics A favorable opinion was received from the Ethics Commission of Freiburg University, Germany (vote: 293/10, date: 09/20/2010). Development of the SEIQoL-Questionnaire We developed the SEIQoL-Q on the basis of the SEIQoLDW by transforming the semi-structured interview guide into a written questionnaire. The original SEIQoL-DW uses interviews to identify each patient’s five most important domains of life (‘‘What are the five most important areas of your life at present?’’). If the patient cannot determine five domains on his own, he is given a list of frequently chosen domains from which he can choose (family, relationships, health, finances, living conditions, work, social life, leisure activities, religion/spiritual life). In the direct weighting procedure, patients are asked to use a disk which allows to show the importance of each domain by giving the more important domains a larger area of the disk, and the less important domains a smaller area of the disk [12]. Analogous to the SEIQoL-DW, participants using the SEIQoL-Q had to name five life domains which they considered most important to them personally. Then, participants were asked to write these domains down on empty lines and rate and weight them using visual analog scales (VAS). We tested the initial version of the SEIQoL-Q by handing out the questionnaire to willing staff members (N = 16) from the radiation oncology unit as well as patients (N = 32) who visited the outpatient clinic on a randomly chosen day. All test persons were asked to name any problems that occurred while filling in the SEIQoL-Q. Whereas staff members did not find it problematic to independently choose and assign important life domains, 7 out of 32 patients found it difficult to complete these tasks. Furthermore, 13 patients had trouble filling in the VAS. Based on this information, we developed a revised, final version of the SEIQoL-Q. Rather than asking participants to independently list five important life domains, we provided (after the question: ‘‘How important to you is the following area of life at the moment?’’) a list of the twelve

Qual Life Res Table 1 Calculation of the SEIQoL Index

Table 2 Patient characteristics

A–L: weights for the 12 areas of life

Characteristics

A%–L%: relative weights for the 12 areas of life normed on 100 % a - l: values from rating satisfaction with the 12 areas of life RA ? B ? C ?  ? L = W100 A% = A/W100 9 100 RA% 9 a/100 ? B% 9 b/100 ? C% 9 c/100 ?  ? L% 9 l/ 100 = IQoL

most important domains found in the literature: family, partnership, friends, social life, finances, work/occupation, physical health, emotional well-being, self-dependence/ autonomy, home/housing, hobbies/leisure, and religion/ spirituality [10, 13]. These domains could then be weighted by participants based on a 5-point Likert scale (0 = not at all important—25 = not very important—50 = important—75 = very important—100 = extremely important). A second part of the questionnaire asked patients to rate their satisfaction with each domain using a 5-point Likert scale (0 = not at all satisfied to 100 = extremely satisfied). An individual QoL index can be calculated (calculation formula: see Table 1). It can range from 0 to 100, with higher values representing better QoL.

N (%)

Gender Male

468 (42.2)

Female

639 (57.7)

Phase of radiation treatment First consultation

303 (27.3)

Ongoing irradiation

114 (10.3)

Aftercare

630 (56.9)

Diagnosis Tumor diseases Head and neck

88 (7.9)

Gastrointestinal tract Respiratory organs and thorax

83 (7.5) 80 (7.2)

Skin

11 (1.0)

Mesothelium, peripheric nervous system, connective tissue

24 (2.2)

Mamma

288 (26.0)

Urogenital tract (except prostate) Prostate

59 (5.3) 119 (10.7)

Eyes, central nervous system, endocrine glands Metastases

35 (3.2) 111 (10.0)

Lymphatic and hematopoietic system

61 (5.5)

Others

Statistical analyses IBM SPSS Statistics 21.0 was used for the statistical analysis. To analyze the acceptance of the questionnaire, we determined the rate of missing data. Two-sided t tests for independent samples were used to investigate differences between subgroups. The reliability (i.e., internal consistency) of the SEIQoL-Q was assessed by Cronbach’s alpha coefficient. To examine the correlations between the SEIQoL-Q and the various QLQ-C30 scales, we used Pearson’s r.

Results Population characteristics A total of 1,108 patients participated in our study. The majority of participants (74.1 %) were cancer patients receiving curative treatment, 19.3 % were cancer patients undergoing palliative treatment, and 6.6 % received radiation therapy due to pain disorders such as arthrosis or calcaneal spur. On average, irradiation had initially begun 2 years prior to participation in the study (range from 0 days to 31 years). The mean age of the patients was 65 years (range 9–91 years). This wide range can be explained by the fact that patients were included consecutively in our study, and neither very old nor very young

Pain disorders

42 (3.8) 104 (9.4)

Totals that do not add up to N = 1,108 are the result of missing values

patients were excluded. Patient characteristics are shown in Table 2. Individual QoL in patients receiving radiotherapy As measured by the QLQ-C30, the average HRQoL was 55.6 (SD = 22.8) on a scale from 0 to 100, with higher values representing better QoL. The average individual QoL index, measured by the SEIQoL-Q, was 59.6 (SD = 16.4). Participants rated ‘‘physical health’’ as the most important life domain, followed by ‘‘emotional wellbeing’’ and ‘‘family.’’ Despite the importance of physical health for patients, this domain received the lowest score in regard to satisfaction. The domains ‘‘home/housing,’’ ‘‘family,’’ and ‘‘partnership’’, respectively, were given the highest satisfaction scores by patients. Table 3 shows the variables of importance and satisfaction in regard to the twelve life domains of the SEIQoL-Q. Influence factors on QoL Although age had no influence on QoL within our sample, other variables showed significant differences. Male

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Qual Life Res Table 3 Variables of importance and satisfaction SEIQoL-Q life domain

Physical health

Importance

Table 4 Influencing factors on the SEIQoL-Q index

Satisfaction

N

M

SD

t

df

p

–2.66

912.5

.008

3.31

903

.001

2.93

1,009

.003

384

.022

N

M

SD

N

M

SD

Gender

1,081

85.3

18.3

1,064

46.1

27.4

Male

454

61.2

17.3

Female

610

58.4

15.5

Emotional well-being

1,065

83.2

18.0

1,048

52.8

25.3

Family

1,068

82.5

21.1

1,055

72.2

23.8

Home/housing

1,073

80.7

18.4

1,055

72.7

20.9

Curative

716

60.9

16.4

23.0

Palliative

189

56.4

17.3

Self-dependence/ autonomy Partnership

1,049

77.3

20.4

1,012

59.7

Phase of treatment 960

75.8

30.5

940

69.3

29.2

Ongoing irradiation

110

55.2

17.9

No irradiationa

901

60.0

16.2

271 115

60.3 64.4

15.3 17.0

Friends

1,053

67.3

22.4

1,036

62.6

21.8

Hobbies/leisure

1,046

60.4

22.9

1,015

54.6

22.5

Finances

1,054

58.0

22.5

1,044

53.5

20.7

Social life

1,031

53.6

24.3

1,003

53.8

21.6

825

47.0

32.2

760

45.9

27.3

1,049

44.3

28.7

982

50.6

25.0

Work/occupation Religion/spirituality

Treatment intention

Diagnosis Breast carcinoma Prostate carcinoma

Two-sided t tests for independent samples, M mean, SD standard deviation a

M mean, SD standard deviation

patients were shown to have a significantly better QoL than females. In comparison with prostate carcinoma patients, those with breast carcinoma had a significantly worse QoL. Table 4 shows the differences between the tested patient groups. Psychometric properties of the SEIQoL-Q For all but two items in the SEIQoL-Q, more than 93 % of all patients provided an answer. Only the life domains ‘‘partnership’’ (86.6 %) and ‘‘work/occupation’’ (74.5 %) had response rates of less than 93 %. The internal consistency of the SEIQoL-Q was calculated at a = .71. The following items correlated with one another: •





the QoL index from the SEIQoL-Q and the functioning scale ‘‘global quality of life’’ from the QLQ-C30 (r = .42, p \ .001), ‘‘satisfaction with physical health’’ from the SEIQoL-Q and the scale ‘‘physical functioning’’ from the QLQC30 (r = .34, p \ .001), the SEIQoL-Q ‘‘satisfaction with emotional wellbeing’’ and the scale ‘‘emotional functioning’’ from the QLQ-C30 (r = .50, p \ .001).

Discussion Improving patients’ QoL is an important goal in health care and in clinical cancer research. Moreover, it is the cornerstone of palliative care [14]. However, measuring QoL is not an easy task because it is as individual as the people themselves. Well-validated instruments like the QLQ-C30

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–2.30

No irradiation = first consultation and aftercare

make it possible to reliably measure HRQoL. Individual QoL, which is much more relevant to patients with incurable diseases, can be measured using other instruments, such as the SEIQoL-DW. Nevertheless, these instruments are complicated, and many patients need help understanding them. For example, complex questionnaire systems like the SEIQoL-DW’s segmented wheel are particularly challenging for cancer patients who are experiencing negative side effects, patients in a poor condition, and elderly patients [15]. Due to the special focus of palliative care on better QoL, patients in need of palliative care are the most important target group for the endpoint QoL [16, 17]. However, until now, there have been few questionnaires that can be easily used among this target group. We therefore decided to develop the SEIQoL-Q, which can be used easily in daily clinical life. The new questionnaire was shown to be appropriate for everyday practice in a high-volume radiotherapy unit and did not involve additional staff. The original SEIQoL uses interviews to identify each patient’s five most important domains of life. If the patient cannot determine five domains on his own, he is given a list of frequently chosen domains from which he can choose [12]. Thus, the list of life domains given by the new SEIQoL-Q does not modify the SEIQoL rules. The list is an important aid for the patients. As shown in other studies, more than 95 % of the patients chose their most important areas of life from these twelve suggestions, and most patients decided on the same domains (family, physical health, and emotional well-being) [18]. The new SEIQoL-Q is designed to be completed by patients. Therefore, we replaced the SEIQoL’s segmented circular diagram, which portrays the five domains allowing

Qual Life Res

a weighting range from 0 to 100 %, with simple, wellknown, and easily understood 5-point Likert scales. This yields slightly less precise weighting results. Yet, we consider the difference to be negligible because our emphasis is on the importance of domains rather than figures. In our study, we found that the most important life domain was ‘‘physical health,’’ followed by ‘‘emotional well-being’’ and ‘‘family.’’ This corresponds to numerous studies which used the SEIQoL-DW with cancer patients (e.g., [19]). The patients in our study attributed the least importance to the domains ‘‘religion/spirituality’’ and ‘‘work/occupation.’’ However, the seeming irrelevance of ‘‘work/occupation’’ might be explained by the high average age of 65, which implies that many patients were likely already retired. The low relevance of ‘‘religion/spirituality’’ might be due to the fact that the terms religious and spiritual cannot be used interchangeably. In the general population in Germany, 30 % do not have a religious affiliation [20] and many individuals describe themselves as spiritual, but not religious. Patients were most satisfied with the life domain ‘‘home/ housing,’’ which ranked fourth in regard to importance. Thus, it appears that home life is of crucial importance to patients and has a positive influence on their individual QoL. Clinically, this result underlines the importance of leaving patients in their accustomed home surroundings and treating them as outpatients whenever possible. Likewise, ‘‘family’’ and ‘‘partnership’’ appear to also have a positive influence on patients’ QoL. For this reason, caregivers should be integrated into the entire treatment process to the extent that this is possible. Regardless of diagnoses, male patients were shown to have a significantly better QoL than females. This could be connected with the differing health concepts of men and women (e.g., the higher symptom consciousness of women [21]). This result also corresponds with the findings from other studies. Investigations in oncology regarding specific symptoms have found an increased severity of depression, anxiety, fatigue, and nausea in women [22]. Kirkova et al. [23] observed gender differences in four cancer symptoms; sleep problems were found to be more prevalent in men, whereas nausea, vomiting, and anxiety were more common in women. These differences should be considered in gender-specific treatment concepts. While the average HRQoL measured by the QLQ-C30 was 55.6, the average SEIQoL-Q index of individual QoL was 59.6. This difference between HRQoL and individual QoL can also be found in other studies. A study by Carlson et al. [24] showed an average SEIQoL-DW index of 69 and a QLQ-C30 index of 57. Frick et al. [25] found a substantially higher SEIQoL index (63.2) compared to a QLQC30 of 51.0. Hence, the SEIQoL-Q and instruments to

measure HRQoL should be viewed as complementary rather than interchangeable. Furthermore, the QoL index of the SEIQoL-Q correlated moderately with the functioning scale ‘‘global quality of life’’ of the QLQ-C30, which was to be expected. Therefore, the SEIQoL-Q index seems to measure a different construct than physical health and functional status, which supports the instrument’s intended focus on individual QoL. Limitations We were able to show that the SEIQoL-Q can discriminate between subgroups and patients differing in clinical status. The examination of the quality criteria acceptance and internal consistency, however, is not sufficient for a psychometric test. Thus, we acknowledge these limitations in our study. To test the questionnaire’s sensitivity to change, one would have had to use a longitudinal study design. If the SEIQoL-Q is to be used parallel to the SEIQoL-DW, its construct validity should be examined. All of these limitations require further investigation.

Conclusions According to our findings, the SEIQoL-Q appears to be a feasible and economical instrument for use in quantitative research in cancer patients in different stages of their disease. The results of our study are useful not only for clinical research but also for clinical practice. Physicians can implement the measure in order to monitor their patients’ QoL and to improve the communication between patients and themselves regarding this topic. Conflict of interest

None.

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Measuring individual quality of life in patients receiving radiation therapy: the SEIQoL-Questionnaire.

Quality of life (QoL) is one of the most important outcomes in cancer care. Although a number of instruments to measure health-related QoL (HRQoL) exi...
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