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Japanese Journal of Clinical Oncology, 2016, 46(5) doi: /jjco/hyw009 Advance Access Publication Date: 16 February 2016 Original Article Original Article Assessment of quality of life of
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Japanese Journal of Clinical Oncology, 2016, 46(5) doi: /jjco/hyw009 Advance Access Publication Date: 16 February 2016 Original Article Original Article Assessment of quality of life of children and adolescents with cancer during their treatment Efrosini Vlachioti 1, Vasiliki Matziou 2, Pantelis Perdikaris 3, *, Maria Mitsiou 4, Christos Stylianou 5, Konstantinos Tsoumakas 6, and Maria Moschovi 7 1 In Service Nursing Education Department, Agia Sophia Children s Hospital, Athens, 2 Department of Nursing, National and Kapodistrian University of Athens, Athens, 3 Department of Nursing, University of Peloponnese, Sparta, 4 HR Management Department, Hellenic MoD of Athens, Athens, 5 Department of Nursing, Technological Educational Institute of Athens, Athens, 6 Department of Nursing, National & Kapodistrian University of Athens, Athens, and 7 Department of Medicine, National and Kapodistrian University of Athens, Athens, Greece *For reprints and all correspondence: Pantelis Perdikaris, Panteleimon Perdikaris, 9 Dirou street, GR , Athens, Greece. Received 21 September 2015; Accepted 12 January 2016 Abstract Objective: The purpose of this study was to evaluate the quality of life of children and adolescents with any type of cancer in all phases of their treatment. Methods: Fifty-six newly diagnosed patients diagnosed with malignancy and hospitalized in a Pediatric Hematology-Oncology Unit in Athens were included in the study. Minneapolis-Manchester Quality of Life Instrument was used for data collection from July 2010 to December The assessment of children and adolescents quality of life who were under treatment was performed in three different stages of treatment. Results: The results of the study showed that the quality of life of children and adolescents with cancer did not change notably during their treatment (F = 0.16, P = 0.86 and F = 0.03, P = 0.97). For the first, at the beginning of the therapy, the score on the scale for quality of life for children and adolescents was 3.44 and 3.88, respectively, in the middle of the treatment 3.36 and 3.89, respectively, and 3.43 and 3.89, respectively, when therapy was completed. Children and adolescents diagnosed with hematologic cancer stated higher quality of life scores (z = 1.61, P = 0.05 and t = 2.64, P = 0.007). Moreover, teenage patients (F = 13.22, P = 0.001) and male patients (t = 2.31, P = 0.02 and t = 2.27, P = 0.02) expressed better quality-of-life scores. Conclusion: According to the results, children and adolescents with any kind of cancer have better quality-of-life scores at the end of their treatment, and when they are supported by their family. Key words: quality of life, children, adolescent, treatment, cancer, gender, age Introduction According to the international literature, pediatric cancer patients in the acute phase of the disease show reduced quality of life (QoL) (1 6). Nowadays, the of QoL in pediatric patients with cancer is perceived that provides an important assessment of the welfare of children and families. Especially, by evaluating different QoL dimensions and in different treatment stages is supported that will assist in detecting children and families with an expected poorer QoL and guide health professionals with targeted interventions to improve it (7 9). Many studies show that all aspects of quality of life, regardless of age, gender, diagnosis as well as the kind of treatment, are affected immediately after diagnosis. Children and adolescents express reduced organ function and autonomy, poor psychological status with reduced The Author Published by Oxford University Press. All rights reserved. For Permissions, please 453 454 Quality of life and pediatric cancer self-esteem and depression, especially during the first 3 to 6 months after cancer diagnosis (1,2,7). According to previous studies, key determinants of QoL deterioration in pediatric cancer patients seem to be painful clinical interventions, surgery, intensive chemotherapy and hospitalization. However, clinical data support that QoL seems to improve about 6 months after diagnosis and much more after completion of the first year of treatment (1 8). According to parental reports from earlier studies, the physical, emotional and social dimensions of the QoL of children with cancer is differentiated according to children s age, gender, diagnosis and the type of treatment. Moreover, in a number of studies, children compared with adolescents expressed a lower level of QoL for the immediate period after diagnosis. In addition, even though female children express greater autonomy than males, results from several studies have shown that they have a lower level of QoL than boys, especially in cognitive and emotional dimensions (2 4,7,9). For example, children with leukemia, especially during the immediate period after diagnosis and the first months of treatment, state a major effect on their QoL with limited autonomy. This is partly attributed to the highly aggressive chemotherapy protocols applied during the therapeutic treatment as well as its complications. Interestingly, there is a noticeable improvement in their QoL, observed during the first year after diagnosis of leukemia (2 4,10,11). In contrast, in cases such as children suffering from brain tumors, since chemotherapy is not much aggressive, their QoL is not significantly affected during the first period after diagnosis and the first year of treatment. However, they express lower QoL after the first year of therapy due to the reduced physical, cognitive, emotional and social function (2,3,7,12,13). Parental support immediately after diagnosis and during treatment has been associated with good QoL for children and adolescents, particularly for the subscale measuring emotional functions and less for the subscales measuring cognitive and social functions of children and adolescents (2,3,10,11,14 18). Aim The main aim of this study was to evaluate the QoL of children and adolescents suffering from any form of cancer, in all phases of their treatment. Moreover, the effect of many possible determinants, such as gender, type of cancer, age and other demographic characteristics, on the QoL was assessed. Patients and methods The sample of the study was all the children and adolescents 8 20 years of age diagnosed with any type of malignancy during the study period. Data were collected from July 2010 to December 2012 in a Pediatric Hematology-Oncology Unit in Athens. Thirty-four children aged 8 12 years old were diagnosed with cancer during the study period. In total, 30 children joined the study, since two mothers denied to sign the informed consent, one patient passed away due to treatment complication before the first, and one child was transferred to another hospital just after the diagnosis. Concerning adolescents, 28 adolescents were diagnosed for cancer during the study period and 26 were included. In one case, mother did not sign the informed consent and one adolescent was excluded from the study due to mental disorder. Research was approved by the Scientific Council of the hospital (reference number: 7853/ ). Inclusion criteria were: (i) Appropriate age: children 8 12 years and adolescents years old (ii) Diagnosis of any form of malignancy (iii) Signed informed consent from both children and their parents (iv) Sufficient knowledge and understanding of Greek language Exclusion criteria were: (i) Diagnosis of any mental disorder or illness (ii) Patients and parents who cannot speak and write in Greek Tools for data collection The questionnaire of Minneapolis-Manchester Quality of Life Instrument (MMOL version for children and adolescents patients) was used for the collection of data. MMOL evaluates the QoL of children and adolescents who are under treatment. The children s version includes 32 items whereas the teenagers version includes 41 items. It consists of seven subscales related to the body image, the cognitive functioning, family relationships, prospects for life, physical functioning and symptoms, psychological functioning and social functioning. The rating for each question ranges from 1 to 5. Level 5 refers to the highest level of QoL and to the minimal negative effect of cancer and its treatment in the QoL. Many studies have checked validity and reliability of the Minneapolis-Manchester QoL questionnaire (19 21). According to the study of Klassen et al. carried out on 162 children and 268 adolescents with cancer, internal consistency reliability Cronbach s α was found to be 0.72 in the children s version (c8 12 years old) in all subscales, and 0.78 in the adolescents version (aged years), in six of the seven subscales (22). Prior to the translation, we obtained permission to use directly from Smita Bhatia by . The translation of instruments was performed in three stages. First, the researcher and two independent translators translated the versions of the tool. At the second stage, the Greek translation for each version was given to two independent translators for reverse translation. At the third stage, the reverse translation for each version of the tools and their original English versions were distributed to a group of experts (two Professors from the University of Athens, two Pediatric Oncologists and two oncology nurses). In this stage, small changes took place according to experts notices and applied to Greek translation of each version. Then the scale was assessed in a pilot sample of children and adolescents. The results showed that the scales of children were reliable and showed a high correlation between the first (test) and the after 4 weeks (retest). According to the therapeutic protocols used during the study period the duration of treatment varied from 6 months to 2 years. More specifically, children and adolescents were under treatment for 2 years for leukemia, 1 year for solid tumors, 1 year for lymphomas and 6 months for non-hodgkin s lymphoma and B-cell lymphoma Burkitt s. The assessment of the QoL of children and adolescents who were undergoing treatment was accomplished in three (3) different stages of their treatment. The s of the QoL in the different phases of treatment at each type of cancer are presented in Table 1. The first was performed at the beginning of the treatment, the second one in its middle and the third one upon completion of the treatment. The period of time at the middle of the treatment, depending on the protocol for each type of cancer, was assigned as the middle of the whole therapy for the second of the QoL. Consequently, the second of the QoL of children and adolescents with any type of leukemia was accomplished 1 year after the first, with any type of solid tumor or lymphoma was performed Jpn J Clin Oncol, 2016, Vol. 46, No Table 1. The s of the quality of life (QoL) in the different phases of treatment at each type of cancer Type of cancer First Second Third Leukemias Tumors Lymphomas Non-Hodgkin s lymphoma and B-cell lymphoma Burkitt s At the beginning of the treatment At the beginning of the treatment At the beginning of the treatment At the beginning of the treatment One year after the first Six months after the first Six months after the first Three months after the first. Two years after the first One year after the first One year after the first Six months after the first 6 months after the first and for those treated for non- Hodgkin s lymphoma or B-cell Burkitt s was measured 3 months after the first. In case that children and adolescents were not hospitalized by the time that their QoL should be measured, the researcher would arrange an appointment in order to collect data. Treatment was considered as completed when the last medication of the last circle of therapy was administered, either in the hospital or in an outpatient clinic, and before the patient entered in the maintenance phase, and he/she did not receive any chemotherapeutic agent or even if during this phase he/she was receiving any chemotherapy in small doses in a regular basis. Statistical analysis The Statistical Package for Social Sciences (SPSS) program, version 21.0 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. Continuous data were expressed as means (±standard deviation), while categorical and dichotomous variables were expressed as percentages of the groups. Descriptive statistical techniques were used to estimate means and frequencies. Kolmogorov Smirnov and Shapiro Wilk statistical tests were used to test the normal distribution of the quantitative variables. The comparisons of the variables followed a normal distribution were performed by using parametric tests (t-test, analysis of variance, ANOVA), while non-parametric methods (Mann Whitney test) were used for variables that violated normality. Moreover, the analysis of data was performed by using the General Linear Model for repeated measures. The reliability of the instrument, as well as its subscales was tested by using the internal consistency coefficient Cronbach s α. AP value of 0.05 was considered statistically significant. Pilot study The pilot study took place from July 2010 to January 2011 on a sample of 23 adolescent patients and 40 survivors of childhood cancer. After the pilot study and recognizing the methodological difficulties encountered mainly due to the small sample, it was decided to merge the leukemia s and lymphomas into one category (type hematologic cancer) and the integration of the two cases mastocytosis (a case in a child and adolescent) in hematologic cancer type too. Finally, the variable marital status was divided into two categories: married parents and divorced, separated or single-parent family. Results Demographic data A total number of 56 children diagnosed with cancer were included in the study. Thirty of them were at school age whereas 26 were adolescents. The mean age of children was ± 1.28 years, while the mean age of adolescent patients was ± 1.72 years. The demographic characteristics of children and adolescent patients are presented in Table 2. Children The reliability of the tool concerning the scale and the subscales for the QoL in children with cancer ranged from 0.56 to The reliability of the subscales about physical functioning and somatic symptoms was low and presented a great level of heterogeneity. In contrast, the higher values of reliability were observed in both at the subscale of mental functioning and the total. The sphericity assumption for the variable of the QoL is not violated (Mauchly s W = 0.96, x 2 = 0.88, df = 2, P = 0.64). The application of the linear-model analysis of variance for repeated measures (GLM-repeated measures) did not prove any statistically significant difference for any variation for the QoL of children during treatment (F (2,44) = 0.16, P = 0.86). The results of the linear-model analysis for the variance of repeated measures did not show any statistically significant interaction between the variation for the QoL during the treatment therapy of children and the gender, the type of cancer, the age group (children aged 8 10 years and children in pre-teens years). Furthermore, none of the examined demographic factors were found to affect statistically significantly the change of the QoL of children during the treatment therapy. The t-test analysis showed the existence of statistically significant differences in relation to gender in the first (at the start of the treatment) and the second (at the middle of the treatment). More specifically, at the beginning and at the middle of the treatment, boys reported better QoL than girls (t (28) = 2.31, P = 0.02) and (t (24) =2.12,P = 0.02), respectively. The results on the differences in ratings for the QoL between boys and girls in all three phases of treatment therapy are presented in Table 3. T-test analysis demonstrated the existence of statistically significant differences regarding the marital status of children s parents and thus the influence of parental support in the second and third. Specifically, children who were living with both parents reported better QoL at the middle and at the end of the treatment compared with those whose parents were divorced or separated (t (24) =2.08,P =0.02andt (21) =2.70,P = 0.007, respectively). The above study results are presented in Table 3. Mann Whitney U-test analysis test demonstrated statistically significant differences at the second and third between gender and the subscale physical functioning. For the second, it was found that boys reported better QoL than girls (z = 2.85, P = 0.002). Similar results were observed at the end of the treatment (z = 1.95, P = 0.02). Statistically significant difference with respect to gender was found in the third for the subscale for mental functioning. Boys recorded the highest score for QoL 456 Quality of life and pediatric cancer Table 2. Demographic characteristics of the sample (children and adolescents) Variables Total, N % Children, 7 12, N % Adolescent, 13 20, N % Leukemia/ lymphoma, N % Solid tumor, N % Gender Male Female Diagnosis Leukemia/lymphoma Solid tumor Nationality Greek Other Brother or sister Yes No Educational level of the mother Primary education Secondary education Higher education Educational level of the father Primary education Secondary education Higher Education Marital status of parents Married Separated Total Table 3. Rating for the QoL of children by gender and their parents marital status during their treatment Gender Boys, M (SD) a Girls, M (SD) t P Mean difference 95% Confidence interval of the difference First 3.54 (0.32) 3.26 (0.33) Second 3.47 (0.35) 3.16 (0.35) Third 3.52 (0.38) 3.25 (0.37) Marital status Married Separated First 3.47 (0.33) 3.19 (0.46) Second 3.41 (0.36) 2.96 (0.20) Third 3.50 (0.34) 2.92 (0.36) a Mean (standard deviation). compared with girls (z = 1.83, P = 0.034). Moreover, gender was found to be a statistically significant factor for the subscale somatic symptoms for the concerning the middle of the treatment, where boys outweighed girls (z = 1.83, P = 0.03). In addition to this, statistically significant difference was found in the same subscale for the second and the third, while testing the type of malignancy, where children with hematological malignancy reported a higher level of QoL compared with those suffering from solid tumors (z = 1.61, P =0,05andz = 2.62, P = 0.003, respectively). Finally in the subscale for perspective for life statistically significant difference was found only for the second, where children aged 8 10 years reported better QoL and consequently optimistic about their future when compared with older children (z = 1.77, P = 0.04). The results are shown in Table 4. Adolescents The reliability of the tool for the QoL in adolescent patients with cancer ranged from 0.84 to Similarly to children, the sphericity assumption for the variable of QoL is not violated (Mauchly s W = 0.83, x 2 = 3.80, df = 2, P = 0.15) in adolescents. The application of the linear-model analysis of variance for repeated measures (GLM-repeated measures) did not found any statistically significant difference for the variation in the QoL for children during treatment (F (2,42) = 0.03, P = 0.97). The analysis of the observed means demonstrated a statistically significant difference only for the first, where adolescents suffering from solid tumors had lower scores for the QoL compared with their peers with hematologic malignancy (t (23) = 2.17, P = 0.02). Statistical analysis for the subscale physical functioning for adolescents with malignancy demonstrated for the first only, a statistically significant difference with respect to the diagnosis since, at the beginning of the treatment, adolescents with hematological malignancy indicated a higher level of QoL compared with those diagnosed with some form of solid tumor (t (23) =2.5, P =0.02). In addition to this, for the subscale for mental functioning there was statistically significant difference regarding gender
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