|Ahead of print
Does educational-supportive program affect anxiety in women with endometrial cancer? Result from a randomized clinical trials
Soudabeh Niroomand1, Samaneh Youseflu1, Mitra Modares Gilani2, Anoshirvan Kazemnejad3, Leila Neisani Samani4
1 Department of Midwifery, Zanjan University of Medical Science, Zanjan, Iran
2 Department of Obstetrics and Gynecology, School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
3 Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
4 Department of Nursing and Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran
|Date of Submission||14-Nov-2018|
|Date of Decision||28-Apr-2019|
|Date of Acceptance||04-May-2019|
|Date of Web Publication||16-Jul-2021|
Leila Neisani Samani,
Department of Nursing and Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran
Source of Support: None, Conflict of Interest: None
Background: Following a diagnosis of cancer, distress is a common reaction. For Iranian women with endometrial cancer, treatment and survivorship can result in disabling symptoms of depression, anxiety, social, and spiritual crises. The aim of this study was to determine whether a combination of education and support intervention as a comprehensive program focusing on education, coping, and support had better short- and long-term effects on anxiety of these patients.
Methods: The current randomized clinical trial was performed on a sample of 140 women with endometrial cancer. A two-part instrument was used - a demographic information form and “Beck's Anxiety” questionnaire. The intervention was an educational-supportive program in 3 weekly sessions in experimental group (N = 70), whereas control group (N = 70) received routine care. Descriptive statistics, Chi-square test, t-tests, and repeated measure analysis of variance were used to analyze data. P value less than 0.05 was considered as statistically significant.
Results: The total scores of anxiety (mean± standard deviation) was significantly lower in the experimental group immediately after intervention (8.46 ± 5.17, P < 0.001), 1 month (7.78 ± 4.59, P < 0.001) and 2 months (7.55 ± 4.55, P < 0.001) after intervention to compare with before intervention (16.82 ± 10.19).
Conclusion: In this study, this program could decrease the anxiety in women with endometrial cancer.
Keywords: Anxiety, education, endometrial cancer, supportive program
Key Message: Providing a supportive program based on education in women with endometrial cancer can play an important role in reducing the anxiety of these women
|How to cite this URL:|
Niroomand S, Youseflu S, Gilani MM, Kazemnejad A, Samani LN. Does educational-supportive program affect anxiety in women with endometrial cancer? Result from a randomized clinical trials. Indian J Cancer [Epub ahead of print] [cited 2021 Jul 27]. Available from: https://www.indianjcancer.com/preprintarticle.asp?id=321672
| » Introduction|| |
According to the reports of the FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) platform Global Library of Women's Medicine, endometrial cancer (EC) is one of the most common gynecological cancer worldwide, and its incidence is increasing. In the year 2020, It's estimated that almost 417367 new cases of EC were diagnosed, and about 97370 women died worldwide from this cancer. Early cancer detection and remarkable improvements in cancer treatment have seen the cancer survival rate grow steadily for the past 40 years., The number of survival is expected to increase continuously. In Iran, endometrial cancer is the second most common gynecological cancer (about 30% of all gynecological cancers).
Following a diagnosis of cancer, distress is a common reaction. For a subset of individuals, coping with diagnosis, treatment, and survivorship can result in disabling symptoms of depression, anxiety, social, and spiritual crises that significantly impact day-to-day functioning. Long-term survivorship is both stressful and hopeful for patients with cancer. During this period, patients with cancer experience physical, psychological, social, and spiritual adjustment. Psychosocial stress contributes to the development of anxiety and depression. In a comparison study of cancer survivors with the general population, depression and anxiety were higher in cancer survivors., Living with cancer is difficult and progressive nature of cancer with distressing symptoms and stressful treatment can raise many psychological and physical problems for patient and their family. In particular, a life course perspective of cancer and cancer survivorship might help predict the health and wellbeing of women after cancer. Uterus is considered as a symbol of femininity among women. Hysterectomy is a main treatment in women with endometrial cancer; losing corpus can negatively affect women mental health. Although the various group interventions differ in their philosophies, approaches, types, and settings, most can be categorized as predominantly supportive or psychoeducational. Psychoeducational and information support interventions also include progressive muscle relaxation, patient's health education and counseling, behavioral training and practice in stress management techniques, problem solving, self-control strategies (such as relaxation, guided imagery), and various other copping skills (goal setting). Review of psychoeducational studies showed that psychological outcomes were described as reduction in some psychological disorders, such as anxiety, stress, or depression scores, better adjustment to illness, or improved coping style.
Also, the vast majority of respondents reported that at diagnosis, they were not offered assistance from a psychologist/counselor, nurse, or other support professional, referral to a patient organization, or clear written information about their disease or treatment.
We identified no previous studies have investigated the educational-supportive care of endometrial cancer patients in Iran. Despite the current emphasis on supportive and educational cares in patients with cancer,,, these approaches have not been attempted in Iran yet.
The main objective of this study was to determine whether a combination of education and support intervention as a comprehensive program focusing on education, coping, and support had better short- and long-term effects on anxiety among patients with endometrial cancer. In addition, we hypothesized that women with endometrial cancer who had participated in an educational and supportive program would feel less anxiety after diagnosis and treatment progresses of cancer.
| » Patients and Methods|| |
The current randomized clinical trial was performed on a sample of women with endometrial cancer that referred to oncology clinic and department of women surgery at Imam Khomeini Hospital Complex of Tehran, Iran, in 2014. The protocol and the ethical issues of the study were approved by the research ethics committee in Tehran University of Medical Sciences, Tehran, Iran. Also, this study was registered in Iranian Registry of Clinical Trials (IRCT2013120515668N1). All participants signed a written informed consent and were assured about the voluntary nature of the participation and the confidentiality of their personal information. Written informed consents were obtained from all the participants prior to the enrollments, following a detailed explanation on study objectives and specific requirements of the survey introduced by researcher.
In total, 140 women were included in the study. The subjects were randomly assigned either into the intervention group (N = 70) or the control group (N = 70). For this reason, a code was assigned to each subject. Then, codes were divided by two equal parts kept in two separate envelops of A and B. Then, one envelop was assigned to the intervention and the other one to the control group. The patients (both experimental and control groups) were asked to choose only one number from each of the item. Control group received routine care that included only hospital's treatment processes (without any educational and supportive program).
Inclusion criteria included age up to 65 years, absence metastases, Iranian race, not having stressful events unrelated with their disease in the past 3 months, not using medication affecting anxiety or other psychological problems, lack of mental retardation, not participating in mental health programs, counseling or educating in the onset about the disease until now, and continuing treatment in the same hospital.We excluded patients who experienced stressful events (unrelated to their illness) during the intervention, absence in one or more sessions, and participate in any similar counseling or training program.
At first, demographic characters was completed by participants. This questionnaire included three parts: individual characters (age, level of education in woman, occupational status), reproductive characters (menarche age, marriage status and age, infertility history, parity, contraceptives), medical characters (past medical history, medication, duration of disease, measures taken for treatment, family history of gynecological cancers and current treatments).
For assessing anxiety disorder, we used Beck's Anxiety inventory., This questionnaire contains 21 questions, each item was scored on a 4-point Likert-type scale of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are 0–9 normal to minimal anxiety, 10–18 mild to moderate anxiety, 19–29 moderate to severe anxiety, and 30–63 severe anxiety. Among Iranian population, the results showed that the inventory has appropriate validity (r = 0.72, P < 001), reliability (r = 0.83, P < 0.001), and internal consistency (Alpha = 0.92).
The intervention was of three sessions. The sessions consisted of three weekly 1 hour one-to-one sessions at the hospital in experimental group that performed by one researcher and included education and informational support such as definition of endometrial cancer, risk factors, symptoms, diagnosis, stages, treatment, paraclinical tests, and prevention of endometrial cancer, complications of chemotherapy and its management, nutrition, anxiety complications, stress management, and finally some relaxation methods, such as breathing techniques, creative visualization, progressive muscle relaxation and positive sentences repetition. It was performed in a classroom of the hospital. To support patients in this program, in addition to taking part in sessions, researcher was available on phone to answer patients' questions and review training.
Immediately after third session, and at 1 and 2 months after intervention “Beck's Anxiety” questionnaire was filled again by self-reporting in trial group. Also, 3 weeks after first meeting, and at 1 and 2 months after the intervention “Beck's Anxiety” questionnaire was filled by control group.
Data analysis was performed by using the SPSS Software (ver. 22). Descriptive statistics were used to describe the sociodemographic characteristics, clinical characteristics. t-test and Mann–Whitney, Chi-square, and repeated measure analysis of variance statistical tests were performed via a forward selection procedure (P value to enter <0.05) to assess the comparison of anxiety scores in two groups of experimental and control before, after, 1 month, and 2 months after investigation.
| » Results|| |
Demographic characteristics (N = 140) are described in [Table 1]. Of these, 63 cases in experimental group and 64 cases in control group under took program completely. The other 13 cases were omitted because of lack of tendency to participate later [Figure 1]. Mean (standard deviation) age of women in experimental and control groups were 52.23 (9.9) and 54.39 (9.25) years, respectively. While only 8.6% in experimental group and 4.3% cases in control group were employee, the most cases (80% in experimental and 88.4% in control group) were multipara, and only 10% cases in experimental group and 12.9% in control group had a family history for gynecological cancer [Table 1]. The trend of anxiety changes in intervention and control groups has been shown in [Figure 2].
|Table 1: Comparison of research units in the control and experimental groups based on the underlying variables|
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|Figure 1: Trial profile outlining randomized control trial design with numbers of patients at each stage|
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|Figure 2: The trend of anxiety changes in intervention and control groups|
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With assumption of variable normality, repeated measure variance was used to analyze the effect of this program on patients' anxiety for 2-month follow-up. The assumption of covariance matrix uniformity was not established (P < 0.001). Since the amount of Greenhouse–Geisser epsilon-corrected value was ~0.37 for anxiety, we used corrected result in this way. Regarding of the significant intragroup effect and existence of more than two groups, we used Bonferroni post hoc test. The result of this test illustrated that all pairwise comparisons before and after intervention were statistically significant (P < 0.001) [Table 2].
|Table 2: Comparison of anxiety scores in two groups of experimental and control before, after, 1 month, and 2 months after investigation|
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| » Discussion|| |
This study was carried out to determine the effect of educational-supportive program on anxiety level of endometrial cancer patients. The results of the current study showed that the anxiety scores of women with endometrial cancer were significantly reduced in the intervention group, whereas controls showed slight increase in anxiety levels in 2 months follow-up. Compared with the control group, experimental group had significant decreased in anxiety level immediately after three sessions.
Recently studies have supported from non-pharmaceutics treatments to reduce stress and anxiety, as two main causes of depression and many psychological disorders. Articles similar to our study showed that women with endometrial cancer who participated in some educational programs and suitable exercises had less physical and mental complications.,, On the contrary, in the study of Chan, a psychoeducational intervention in women with gynecological malignancy could not improve in stress symptoms. Several explanations are possible: first, this survey studied several gynecological malignancies that the effect of their program might be weak for various kinds of gynecological cancers. Second, their sample size might not be sufficient to show the difference. Also, they worked on only psychological therapies to improve psychological status. But our study worked on only one type of cancer in women and we used a large sample size for our population that was measured by a standard questionnaire in this issue. Also, we used a comprehensive program which contained educational and supportive issues.
An intervention base on mindfulness on patients with breast cancer demonstrated that there were no meaningful differences between experimental and control group in terms of emotional distress. It means two groups both showed improvement in emotional distress. The difference between our research and current study is that we used a combined program of support and education to reduce anxiety in patients who suffered from endometrial cancer.
A supportive program based on education can be reckoned as one of the solutions for reducing anxiety in cancer patients. Therefore, having a comprehensive program for patients with endometrial cancer, as a large group of women with gynecological cancer, seems vital to control their anxiety. This study, therefore, clarifies the role of informational support and education in relation to healthcare service use to guide future development of innovative informational interventions and seeks to optimize healthcare service use by patients diagnosed with endometrial cancer and to provide new insights for integrating educational and informational support into routine care. In our knowledge, no study has considered the influence of a supportive-educational program on anxiety level of women with endometrial cancer in Iran.
In the Islamic Iranian culture, women have an important role as wives or mothers in stability of family. Regarding the sociocultural structure, Iranian women with cancer to comparison with Western women are afflicted cancer because they believe that cancer is a fatal disease. Also, lack of integrated organized support system can lead to psychological problems, such as anxiety.
Due to Iranian culture, patients' family declared excessive sympathy to encounter with a family member suffering from cancer. Some women with cancer tend not to say anything about their disease to their family that increase stress, anxiety, or loneliness.,,
Therefore, presence of a health provider care who has information about cancer could decrease the level of anxiety and psychological problems of women with endometrial cancer.
This study has some limitations: first, these patients were followed for 2 months after intervention. It would be better that women with endometrial cancer were followed >2 months. Second, our participants were Iranian women, and our findings may not be generalizable to other cultural groups. Finally, other studies are needed to evaluate the efficacy of other strategies interventions, such as psychological interventions (e.g., group therapy, cognitive behavioral therapy, etc.).
| » Conclusion|| |
In conclusion, administrative means should be sought to increase availability of educational and informational supportive program by educated group of medical sciences to decrease waits to see oncology and gynecology specialists, receive the endometrial cancer diagnosis, and undergo postsurgical and other therapies.
All authors have seen and approved the final version of the manuscript being submitted. All authors warrant that the article is the authors' original work, has not received prior publication, and is not under consideration for publication elsewhere.
This study was carried out with the kind collaboration of the participants. We would also like to appreciate the staff of Imam Khomeini Complex Hospital for their valuable contributions.
Financial support and sponsorship
This study was financed by Tehran University of Medical Sciences, Tehran, Iran.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]