Evaluation of quality of life in patients treated for colorectal cancer at the University Hospital Trnava

Ľubica Ilievová*, Daniel Jirkovský, Gabriela Vöröšová, Monika Střádalová Department of Nursing, Faculty of Health and Social Work, Trnava University, Trnava, Slovak Republic Department of Nursing, Charles University Medical Faculty, Prague, Czech Republic Department of Nursing, Constantine the Philosopher University in Nitra, Slovak Republic Department of Surgery, University hospital Trnava, Trnava, Slovak Republic


INTRODUCTION
The growing incidence of colorectal cancer (CRC) is alarming.There are 940,000 new cases diagnosed and a mortality of approximately 500,000 patients The diagnosis of CRC and the following treatment lead to complex psychomotor, functional, and social impairment, which all affect the quality of life (QoL) (3).Recently, QoL has been considered to be an important component of treatment outcomes.Therefore, research became more focused on psychosomatic and physical well-being (4).
The QLQ-CR29 questionnaire was developed by the European Organization for Research and Treatment of Cancer (EORTC) and is widely used in CRC patients within Europe.
Slovak validation of QLQ-CR29 was completed at the Department of Surgery, Faculty Hospital Trnava in collaboration with EORTC.
The aim of the study was to evaluate QoL in patients with CRC during complex treatment using EORTC QLQ-C30 and QLQ-CR29 questionnaires and to implement routine QoL assessment into practice.

METHODS
The observational study was performed, and data are presented using descriptive statistics.

QoL questionnaire
Data collection was performed using the EORTC QoL questionnaire C30 (EORTC QLQ-C30) and the EORTC QLQ-CR29 module at the Department of Surgery, Faculty Hospital Trnava, Slovakia, from May 2014 until April 2015.
All patients with CRC included in the study completed a validated questionnaire in the Slovak language before the initiation of treatment and 1 month after surgery.
Each patient was informed by a clinician about the diagnosis before the first assessment.The patients completed the questionnaire independently with adequate time provided.
The cohort of 46 patients was divided into two groups depending on the tumor location: Group 1 included patients with colon cancer and Group 2 included patients with rectal cancer (tumor located within 15 cm from linea dentata).Data from the questionnaires were processed using the original software provided by the EORTC.

Statistical analysis
Data were analyzed with Statistical software SPSS 22.0.01 using means with standard deviations, a paired t-test, and independent t-test.Both groups were compared using an independent t-test.The difference between pre-and post-operative QoL outcomes was assessed with a paired t-test.P ≤ 0.05 was statistically significant.

RESULTS
The comparison of QoL in patients with colon cancer (Group 1) and rectal cancer (Group 2) is presented in Table 2 (Table 2).
The mean global health status of the cohort was 42.4-43.4preoperatively, and these values increased to 47.7-52.6 1 month after the procedure.The patients with colon and rectal cancer differed significantly in the score of buttock pain 1 month after surgery (p = 0.001).
A significant difference was also observed between these two groups in mouth dryness (p = 0.042), impotence (p = 0.035) and sore skin around the anus in patients without stoma (p = 0.039).
The outcomes of QoL assessment in patients with CRC stratified by age are presented in Table 3 (Table 3).
The mean global health status was 30.6-52.8 within the whole cohort.A significant difference between the two age groups was found before the surgery (p = 0.007).The score of sexual interest in the group of men differed significantly between these groups before (p = 0.020) and after surgery (p = 0.007).The fatigue score and the constipation score showed significant differences (p = 0.019 and p = 0.028, respectively) before the operation.1 month after surgery a statistically significant difference was observed in financial difficulties (p = 0.020).
The outcomes of QoL evaluation in patients with CRC stratified by gender is shown in Table 4 (Table 4).
The mean global health status was preoperatively <50.0 in both genders.In the second assessment, 1 month after surgery, the scores for men and women were 47.1 and 58.3, respectively.
A significant difference was found between men and women for body image (p = 0.031) and constipation scores (p = 0.007) 1 month after surgery.There was also a significant difference identified for anxiety before surgery (p = 0.023).
The evaluation of QoL in patients with and without stoma is presented in Table 5.
The mean global health status of the studied sample was 36.7-51.7.A significant difference was identified in the physical functioning domain between patients with and without stoma 1 month after surgery (48.0 vs. 70.7;p = 0.024).A statistically significant difference was found in the fatigue score preoperatively (p = 0.045) and 1 month after surgery (p = 0.047).The evaluation of QoL in patients with rectal cancer with and without neoadjuvant CRT is presented in Table 6.
The mean global health status of patients in the studied cohort was 41.7-50.0.A significant difference between patients who were not treated with neoadjuvant CRT and who completed neoadjuvant treatment was observed in the cognitive functioning domain in the time before surgery (p = 0.010).
The presence of blood and mucus in stool was more frequent in the group with completed neoadjuvant CRT 1 month after surgery (p = 0.023).

DISCUSSION
CRC represents the most common malignant tumor of the gastrointestinal tract and the second most frequent malignancy after lung cancer in men and breast and ovarian cancer in women (5)  0.002 0.586 FA: Fatigue, CO: Constipation, FI: Financial difficulties. 1 -Data are presented as means with standard deviation and mean difference with 95% confidence interval, 2 -results from independent t-test, 3 -results from paired t-test, 4 -Group 1: Men n=12, women n=6; Group 2: Men n=8, women n=4, 5 -Group 1: With stoma at entry n=1, without stoma at entry n=17, with stoma in 1 month n=4, without stoma in 1 month n=14, Group 2: With stoma at entry n=2, without stoma at entry n=10 with stoma in 1 month n=6, without stoma in 1 month n=6 significant differences between patients with colon and rectal cancer was found 1 month after surgery for ratings of buttock pain (p = 0.001), mouth dryness (p = 0.042), impotence (p = 0.035), and sore skin around the anus in patients without stoma (p = 0.039).
The outcomes from our research differ from Ramsey et al. (7), who studied 227 patients with CRC and observed high scores of QoL, regardless of tumor localization, staging, and disease duration.Comorbidities and financial problems were of significantly higher negative impact.0.076 0.052 BI: Body image, CO: Constipation, ANX: Anxiety. 1 -Data are presented as means with standard deviation and mean difference with 95% confidence interval, 2 -results from independent t-test, 3 -results from paired t-test, 4 -men: With stoma at entry n=1, without stoma at entry n=19, with stoma in 1 month n=7, without stoma in 1 month n=13, 5 -women: With stoma at entry n=2, without stoma at entry n=8, with stoma in 1 month n=3, without stoma in 1 month n=7  (11).
In our cohort of CRC patients with ≥65 and <65 years of age, the mean global health score varied between 30.6 and 52.8 and a statistically significant difference was observed between these groups preoperatively (p = 0.007).A significant difference between these groups was also found for sexual interest in subgroups of men preoperatively (p = 0.020) and 1 month postoperatively (p = 0.007).Preoperatively, these two groups of ≥65 and <65 years old showed a significant difference in the fatigue score (p = 0.019) and constipation score (p = 0.028). 1 month after surgery, there was a statistically significant difference in financial problems (p = 0.020).
Similar outcomes were published by Arndt et al., who found a difference between two age groups (≥60 and <60 years old).They found that the group below 60 had more financial problems.A lower score in the physical functioning domain was observed in patients who returned to work after completing treatment (12).On the other hand, Forsberg et al. did not confirm age as an indicator of QoL in patients with CRC (13).
Gender affects the incidence of CRC.Men have significantly higher incidence of CRC, especially in rectal cancer.The ratio between colon and rectal cancer varies in different countries [9].significant difference in cognitive functions between male and female patients.Men showed better cognitive functions in comparison with women.Mean scores of symptoms (fatigue, pain, nausea and vomiting, constipation, diarrhea, insomnia, shortness of breath, and loss of appetite) varied between 4.00 and 20.7.Women showed worse symptoms for pain, fatigue and shortness of breath (14).
In our research, the gender adjusted mean global health status score varied between 40.8 and 58.3.
A statistically significant difference between men and women was observed 1 month after the surgical procedure for body image (p = 0.031) and constipation (p = 0.007).Preoperatively, a significant difference was found for anxiety (p = 0.023).
Similar results were published in a German study by Arndt et al. who assessed 439 patients with CRC 1 year from diagnosis using QLQ-C30 questionnaire.The most significant differences were gender related.Men reported better outcomes in emotional and cognitive components of QoL than women.On the other hand, the female patient achieved the worst results for pain, insomnia, tiredness, constipation, and loss of appetite (4).
Hendren et al. performed a trial on sexual dysfunction in male and female patients after rectal cancer surgery.In total, 81 women and 99 men were included in this study.Of the sexual problems evaluated by the EORTC questionnaire, women reported changes in libido and pain and discomfort during intercourse.Male patients reported changes in libido, impotence, and partial impotence.Both genders perceived their body image negatively.The authors suggested that the risk of sexual dysfunction is rarely discussed before rectal cancer surgery and little attention is payed to the treatment of these complications (15).
Patients with stoma experience a number of losses, such as the loss of ability to control defecation and passage of gas, which can affect normal social life and lead to negative feelings and social and psychological isolation.Patients lose dignity have feelings of inferiority and their body image and self-esteem suffer.Many times, they are not able to face these situations and are self-disgusted (16).
In our study, the stoma adjusted mean global health status was 36.7-51.7.In physical functioning, a significant difference was observed 1 month after surgery between patients with and without stoma (p = 0.024).Moreover, a statistical difference was found before (p = 0.045) and 1 month after surgery (p = 0.047) for the fatigue score.Of all searched papers published between 1969 and 1992, 17 studies were identified, which evaluated at least one of four aspects of patient functioning (physical, psychical, social, and sexual) and compared the groups with and without stoma.The study concluded that both groups of patients suffer from frequent irregular bowel motions and diarrhea.However, patients with stoma reported higher psychical distress.Both groups reported deterioration in social functioning.However, these problems are more common in patients with colostomy (18).
Radiotherapy remains a part of a multimodal approach and is currently applied either as a neoadjuvant or adjuvant treatment (19).According to Büchler, radiotherapy plays an important role in reduction of local recurrence and palliative therapy of both symptomatic and high-risk metastatic lesions (10).
In our research, the rectal cancer patients with and without complete CRT were compared.The mean global health status of these patients was 41.7-50.0.A significant difference between the above-mentioned groups was found in cognitive functioning (p = 0.010) and in blood and mucus in stool 1 month after surgery (p = 0.023).
Arndt et al. presented QoL outcomes 1 year after diagnosis and after treatment (surgery, chemotherapy, and/or radiotherapy).Higher scores for physical and cognitive functioning; however, lower scores for emotional functioning were observed while 80% of patients felt depressed, irritated, nervous, and fearful (12).
A Norwegian prospective study including 42 patients with rectal cancer was published by Guren et al. in 2003 that evaluated symptoms and QoL during neoadjuvant radiotherapy.QLQ-CR38 was completed at the beginning, at the end of radiotherapy and 4-6 weeks afterward.The scores for diarrhoea, fatigue, and loss of appetite were higher after radiation compared to initial values.The authors found 64% of patients felt fatigue and 52% had worsened diarrhea during the treatment.However, the overall QoL assessed 4-6 weeks after radiotherapy was comparable with values measured before the treatment (20).
The limitation of our study was that the first QoL assessment was scheduled relatively shortly after surgery.Nevertheless, our primary aim was to determine the suitability of QoL evaluation in a homogenous group of patients with CRC and implement this method into practice.Thus, we created conditions for long-term follow-up and QoL evaluation as a component of complex care of patients with CRC.

CONCLUSION
In addition to routinely monitored data during complex treatment of patients with CRC (length of stay, blood loss, early and late complications, overall survival, disease-free interval, etc.), QoL is an equally important outcome of medical, surgical, and nursing interventions.The QoL reflects the individual postoperative limitations of everyday activities and provides a feedback on how the treatment affects patients' lives.Currently, non-physician healthcare professionals are getting more involved in data collection and evaluation.
A significant correlation between the QoL score and the type of treatment was found in our study.Neoadjuvant CRT and surgery with stoma seemed to have a negative effect on overall QoL.

TABLE 3 .
The quality of life stratified by age groups (≥65 years and<65 years)

TABLE 4 .
The outcomes of quality of life evaluation in patients with CRC stratified by gender

TABLE 5 .
Evaluation of quality of life in patients with and without stoma

TABLE 6 .
Evaluation of quality of life in rectal cancer patients without (Group 1) and with completed neoadjuvant CRT (Group 2) Cognitive functioning, BMS: Blood and mucus in stool. 1 -Data are presented as means with standard deviation and mean difference with 95% confidence interval, 2 -results from independent t-test, 3 -results from paired t-test, 4 -Group 1: Men n=1, women n=1; Group 2: Men n=6, women n=3, 5 -Group 1: With stoma at entry n=0, without stoma at entry n=2, with stoma in 1 month n=1, without stoma in 1 month n=1, Group 2: With stoma at entry n=1, without stoma at entry n=8, with stoma in 1 month n=4, without stoma in 1 month n=5