Cervical cancer (CC) is one of the most common diagnosed malignancy cancers in worldwide.[1–3] It is also one of the most leading causes of cancer among female population. It often happens at the locations of the cervical canal and vagina, or transitional zone. It has been estimated that about more than 530,000 new cases increase annually and more than 275,000 deaths occur each year.[6–8]
Many factors are reported to result in CC, such as oncogenic human papillomavirus (HPV), precocious intercourse, multiple sexual partners, multiple pregnancies, and smoking.[9,10] Of those, persistent infection with oncogenic HPV is the most common cause of CC. Moreover, early gene coding proteins of HPV can also cause CC.
The treatment options of CC mainly consist of surgery, chemotherapy, radiotherapy, concurrent radiochemotherapy, and targeted therapy.[11,12] Of these therapies, radiotherapy is often widely used, because of its wide range and high cure rate. Unfortunately, this kind of intervention also leads to physical conditions, psychology, and social functions, as well as menopause symptoms, lower quality of sex life, hematuria, frequent micturition, bloody stool, and pain. All these side-effects also cause psychologic conditions, which also impact the prognosis and treatment of CC.
Presently, few studies explored the effect of high-quality nursing care (HQNC) for patients with CC. Thus, in this pilot study, we tried to investigate the feasible effect of HQNC for patients with CC.
2 Patients and methods
This study was approved by the Ethics Committee of Second Affiliated Hospital of Shaanxi University of Chinese Medicine. All CC participants provided written informed consent.
This study was conducted between January 2016 and December 2017 at Second Affiliated Hospital of Shaanxi University of Chinese Medicine. A total of 42 patients with the confirmed diagnosis of CC at stage I, II, or III via cervical scraping smear and biopsy were enrolled in this study. All patients admitted in the department of gynecology of the Second Affiliated Hospital of Shaanxi University of Chinese Medicine. The inclusion criteria consisted of patients with complete data information, normal hearing and communication skills, as well as the ability to take part in the outcome assessment independently. Exclusion criteria included local recurrence or other malignant tumors, mental conditions, and intellectual disability, receiving chemotherapy or radiotherapy. In addition, patients were also excluded if they received HQNC or psychosocial treatment three months before the study, as well as the psychologic problems, or other complications that affected the outcome assessments.
2.3 Intervention schedules
Patients in both groups received routine care by 3 experienced nurses. Routine care included daily life care, oral care and patients’ condition observation closely. In addition, the patients in the treatment group also received psychologic treatment, 30 minutes each session, 1 session daily, 5 sessions weekly for a total of 4 weeks. The psychologic treatment consisted of a gratitude diary and a mindfulness-based intervention. The nurses instructed each patient to the details of psychologic treatment, and provided him or her manual containing instruction and guidance of such treatment. Then each subject was asked to practice this intervention to make sure that it was correctly.
2.4 Outcome measurements
The primary outcome was anxiety. It was measured by Beck Anxiety Inventory (BAI). It is a widely used 21-item self-report scale. It is used to evaluate the anxiety symptoms. The score from 0 to 7 demonstrates low anxiety, from 8 to 15 mild anxiety, from 16 to 25 moderate anxiety, while the sum score of more than 26 indicates a severe anxiety.
The secondary outcomes comprised rumination and emotion. The rumination was assessed by the ruminative responses scale (RRS), with 22 items by Likert-type scale. Each item ranges from 0, can perform almost never, to 4, perform almost always. The higher score indicates the severe rumination. It was validated by the previous study. The emotion was evaluated by the Emotion Regulation Questionnaire (ERQ). It includes 6 items. Subjects were asked to reply each item by using 7-point Likert scale, varies from 1, strongly disagree, to 7, strongly agree. The higher score revealed more reappraisal use. All primary and secondary outcomes were measured before and after 4-week treatment.
2.5 Statistical analysis
Sample size was calculated by the Software PASS 11. Because of the short duration, the desired sample size for this pilot study was 58 subjects, with 29 patients each group, which is the minimum sample size to assess the effect of HQNC for CC. No randomization and blinding procedure was applied in this study.
All characteristic values and outcome data were analyzed by using SPSS software (SPSS V.15.0; IBM Corp, Armonk, NY). Dichotomous variables were performed by Fisher exact test, while continuous data were operated by Mann–Whitney U test. A value of P < .05 was defined as a statistical significance.
The characteristic values of all included patients in both treatment group and control group are summarized in Table 1. No significant differences in all values were detected between 2 groups at baseline.
After 4-week treatment, subjects in the treatment group demonstrated better outcomes in anxiety, measured by BAI score (minimal, P = .04; mild, P = .19; moderate, P = .19; Table 2); and rumination, measured by RRS (P < .01, Table 3); as well as the emotion, measured by ERQ (P < .01, Table 4), compared with patients in the control group.
Currently, no study specifically investigated the effect of HQNC for patients with CC. To our best knowledge, this pilot study is the first study to explore the feasible effect of HQNC for CC. Although this study just assessed the feasible effect of HQNC, it will still provide helpful evidence for either the clinical practice or for the similar future studies regarding the HQNC for treating CC.
The results of this study showed that patients in the treatment group showed better outcomes in anxiety, measured by the BAI; rumination, evaluated by RRS; and emotion, assessed by ERQ scale, compared with subjects in the control group. The results indicated that the feasibility effect of HQNC may be efficacious for patients with CC among Chinese female population.
This study has several limitations. Firstly, the sample size was pretty small, which may affect the results of HQNC for CC. Secondly, the outcome tools were not comprehensive, because it only assessed the anxiety, rumination, and emotion, but not the quality of life. Thirdly, this study did not comprise follow-up evaluation after the 4-week assessment, therefore, this study only explored the short-term effect of HQNC for CC. Fourthly, this pilot study just assessed the feasibility effect of HQNC for patients with CC. Thus, more high-quality studies are still needed to further warrant the results of this study. Finally, this study did not apply procedure of randomization and blinding, which may increase the risk of case selection.
The results of this study showed that HQNC might be effective for patients with CC after 4-week treatment. Future studies are still needed to warrant this result.
Conceptualization: Ya-hui Fu, Zhao-rong Wang.
Data curation: Ya-hui Fu, Zhao-rong Wang.
Formal analysis: Ya-hui Fu.
Investigation: Zhao-rong Wang.
Methodology: Ya-hui Fu.
Project administration: Zhao-rong Wang.
Resources: Zhao-rong Wang.
Software: Ya-hui Fu.
Supervision: Zhao-rong Wang.
Validation: Zhao-rong Wang.
Visualization: Zhao-rong Wang.
Writing – original draft: Ya-hui Fu, Zhao-rong Wang.
Writing – review & editing: Ya-hui Fu, Zhao-rong Wang.
. Vu M, Yu J, Awolude OA, et al. Cervical cancer worldwide. Curr Probl Cancer 2018;S0147-0272 (18)30134-X. [Epub ahead of print].
. Oyervides-Muñoz MA, Pérez-Maya AA, Rodríguez-Gutiérrez HF, et al. Understanding the HPV integration and its progression to cervical cancer. Infect Genet Evol 2018;61:134–44.
. Ghebre RG, Grover S, Xu MJ, et al. Cervical cancer control in HIV-infected women: past, present and future. Gynecol Oncol Rep 2017;21:101–8.
. Ma L, Liu JM, Zhang J, et al. A pilot study of oral S-1 for treating heavily pretreated patients with advanced or recurrent cervical cancer among Chinese population. Medicine (Baltimore) 2018;97:e10922.
. Hang D, Yin Y, Han J, et al. Analysis of human papillomavirus 16 variants and risk for cervical cancer in Chinese population. Virology 2016;488:156–61.
. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA: A Cancer Journal for Clinicians 2011;61:69–90.
. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA: Cancer J Clin 2012;62:10–29.
. Sharma M, Bruni L, Diaz M, et al. Using HPV prevalence to predict cervical cancer incidence. Int J Cancer 2013;132:1895–900.
. Lorin L, Bertaut A, Hudry D, et al. About invasive cervical cancer: a French population based study between 1998 and 2010. Eur J Obstet Gynecol Reprod Biol 2015;191:1–6.
. Jiamset I, Hanprasertpong J. Risk factors for parametrial involvement in early-stage cervical cancer and identification of patients suitable for less radical surgery. Oncol Res Treat 2016;39:432–8.
. Gupta S, Maheshwari A, Parab P, et al. Neoadjuvant chemotherapy followed by radical surgery versus concomitant chemotherapy and radiotherapy in patients with stage IB2, IIA, or IIB squamous cervical cancer: a randomized controlled trial. J Clin Oncol 2018;36:1548–55.
. Kang YJ, O’Connell DL, Lotocki R, et al. Effect of changes in treatment practice on survival for cervical cancer: results from a population-based study in Manitoba. Canada BMC Cancer 2015;15:642.
. Serkies K, Jassem J. Concurrent weekly cisplatin and radiotherapy in routine management of cervical cancer: A report on patient compliance and acute toxicity. Int J Radiat Oncol Biol Phys 2004;60:814–21.
. Le Borgne G1, Mercier M, Woronoff AS, et al. Quality of life in long-term cervical cancer survivors: a population-based study. Gynecol Oncol 2013;129:222–8.
. Atanasova D. Current methods for optimization of the cervical cancer diagnosis. Akush Ginekol (Sofiia) 2011;50:3–7.
. Beck AT, Epstein N, Brown G, et al. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol 1988;56:893–7.
. Han X, Yang HF. Chinese version of Nolen-Hoeksema ruminative responses scale (RRS) used in 912 college students: reliability and validity. Chin J Clin Psychol 2009;17:550–1.
. Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and wellbeing. J Pers Soc Psychol 2003;85:348–62.
. Wang L, Liu HC, Li ZQ, et al. Reliability and validity of emotion regulation questionnaire Chinese revised version. China J Health Psychol 2007;15:503–5.