The effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer: A randomized controlled clinical trial

Abstract Aim To investigate the effect of a supportive program on coping strategies and stress in women with breast cancer. Design A randomized, two‐armed, controlled trial. Methods Sixty women were randomly allocated to intervention group (N = 30) and control group (N = 30). The interventions were held in six sessions, weekly from August 2018–March 2019 It was consisting of education regarding breast cancer; progressive muscle relaxation; stress management; emotional coping; and problem‐solving strategies. Results At baseline, there was no difference between the two groups regarding the mean score of coping strategies and stress. Supportive program group participants experienced a significantly higher increase on their problem‐oriented coping strategies score in comparison with the control group. At the same time, scores in emotion‐oriented coping strategies and stress decreased significantly in the intervention group compared with the control group. Result of this study can be used to develop relevant interventions targeting coping strategies to reduce stress among women with breast cancer.


| INTRODUC TI ON
Breast cancer is the most common cancer in women (Richardson et al., 2017;Yu et al., 2014), accounting for 33% of all types of cancer and 19% of deaths caused by cancer in women (McFarland et al., 2018;Samami et al., 2019Samami et al., , 2020. Breast cancer diagnosis and treatment are one of the main sources of stress and crisis in women's lives (Andolhe et al., 2009;Kim et al., 2010;Samami et al., 2020). Women with breast cancer undergoing chemotherapy, experience a more significant stress level (Samami et al., 2019). These stresses are due to the lack of information, reduced self-efficacy, inability to the adaptation to their new status, changes in the body image and fear of death (Anusasananun et al., 2013;Leal et al., 2015;Sajadian et al., 2017;Samami et al., 2019;Silva et al., 2017). If these stressors are not properly managed, they can lead to relapses of cancer, prolonged treatment, severe depression, anxiety and reduced quality of life in women diagnosed with breast cancer (Stagl et al., 2015;Walshe et al., 2017).
Coping includes using the adaptive and maladaptive coping mechanism to control and manage stressful situations and adapt to a threat (Badrian et al., 2014). In fact, coping is an important modifier in the relationship between stress and its side effects (Andolhe et al., 2009;Shoaa Kazemi et al., 2014). More effective, efficient and adaptive coping strategies lead to more decrease in stress (Behzadipoor et al., 2013). The coping strategies are divided into two general categories: Problem-Focused Coping (PFC) and Emotion-Focused Coping (EFC) strategies (Folkman & Lazarus, 1988;Folkman et al., 1986). In PFC, all efforts are done to change the leading causes of stress as well as problem-solving (Ahadi et al., 2014;Andolhe et al., 2009), while, in EFC, efforts are towards regulating the emotional responses to stressful events and emotional reactions (Andolhe et al., 2009;Hajian et al., 2017;You et al., 2018).
These strategies do not solve the problem and just relax the patient and reduce the amount of stress (Andolhe et al., 2009). If women diagnosed with breast cancer believe in the controlling effects of stress and its side effects, they may use adaptive coping strategies, but, if this stressful situation is uncontrollable, they will focus on maladaptive strategies (Ahadi et al., 2014). The studies indicate that using adaptive coping strategies are effective in reducing stress, provides social and mental adjustment and enhances the quality of life in women with breast cancer (Behzadipoor et al., 2013;Shoaa Kazemi et al., 2013).
Supportive program is one of the effective mechanisms for improving coping strategies. This program includes providing information and counselling as well as training in coping strategies (Andolhe et al., 2009;Han et al., 2008;Khalili et al., 2013). Women diagnosed with breast cancer that are undergoing chemotherapy, experience more psychological trauma and need interventions to cope with these problems (Nikbakhsh et al., 2014;Pelekasis et al., 2016).

| BACKG ROU N D
A review of the existing literature shows the controversial results about the effectiveness of psychological interventions to improve coping strategies in women with breast cancer. In one way, it has been showed that cognitive-behavioural intervention improves PFC, decreases EFC; stress and negative mood in women diagnosed with breast cancer (Behzadipoor et al., 2013;Shoaa Kazemi et al., 2013). Other studies found that cognitive-behavioural therapy based on positive self-talk as well as spiritual-religious intervention lead to enhanced coping strategies in women diagnosed with breast cancer, but the results were not significant (Ghahari et al., 2017;Hamilton et al., 2011). It seems these interventions help women diagnosed with breast cancer to make suitable decisions, improve their self-care, adapt to their new status and reduce stress by enhancing their information; abilities and self-confidence (Behzadipoor et al., 2013;Hamzehgardeshi et al., 2017;Heravikarimvi et al., 2006). It should be mentioned that while the results of studies are different, all of these studies emphasize and encounter the need for more studies in regards of coping strategies interventions, in form of supportive and emotional interventions (Ghahari et al., 2017;Hajian et al., 2017).
Women with breast cancer often experience a lack of supportive care and encounter program many psychological traumas that in fact needs professional care. Usually, in countries with low or middle income, supportive care and long-term follow-up programs are very limited (Cardoso et al., 2013). In these cases, supportive care programs are not considered as an integral part of the treatment and are often subjected to many restrictions. However, supportive care turned into a structured, mapped out program can be of significant value to all healthcare professionals. Therefore, considering the increasing numbers of breast cancer in low-and middle-income countries, (Ganz et al., 2013;Yip & Taib, 2012) and the crucial effect of supportive care in long-term treatment of patients, this study was designed.

| Aim
This study aims to answer the following question: 1. Does supportive programs compared with routine care improve coping strategies in women with breast cancer? 2. Does supportive programs compared with routine care decrease stress in women with breast cancer?

| Design
This is a randomized two-armed controlled clinical trial, pre-test posttest and follow-up for one month after the intervention to determine the effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer.

| Setting and sample size
Recruitment took place in the chemotherapy ward of a referral hospital of Sari a city located north of Iran, from August 2018-March 2019. In the power analysis, at least 60 participants (30 in each group) were required for the study with a power of 0.84, to obtain a moderate effect size of 0.5 on EFC score (Shoaa Kazemi et al., 2014) at 5% significance level, a confidence interval of 0.95 and a 20% attrition rate between baseline and follow-up.

| Inclusion criteria
Inclusion criteria were at least elementary level education, stage of I-III breast cancer (according to the patient's medical record), maximum one year after cancer's initial diagnosis, patients undergoing chemotherapy (at least one chemotherapy session), breast cancer with no concurrent history of another cancer, no hospitalization in the psychiatric ward, no using of psychiatric drugs (antipsychotic and antidepressant), no psychiatric disorders (according to each individual's history) and no severe depression and anxiety (according to DASS-21 questionnaire).

| Exclusion criteria
Exclusion criteria consisted of participation in other psychotherapy interventions after inclusion, severe psychiatric symptoms which needed treatment, exacerbation of cancer (incidence of new metastases or development of the disease stages) according to the patient's medical record, participation in educational and counselling courses on breast cancer over the past six months, use of alternative interventions such as traditional medicine and adverse life events, including death of family members (spouse, child, father, mother, sister and brother), divorce, spouse abandonment and severe accident occurred during the study or the past 6 months.

| Randomization
In this study, the participants were randomly divided into two groups.
The permuted block randomization by computer software was used to select 10 blocks, each with six participants, such that each block had the same number of participants in the intervention and control groups.
Sixty envelopes were prepared, and the intervention and control groups were placed in groups I (intervention) or group C (control) in each envelope. The first eligible patient took the first envelope and if group I was written on the envelope, it was included in the intervention group and if group C was written on the envelope, it was included in the intervention group. Whenever, the number of intervention groups reached 10, the first intervention session began for that group. Thus, the intervention group was divided into three groups of 10 eligible participants.

| Intervention
A supportive program protocol was developed by extensive review of the existing literature. Then, content validity of the protocol was confirmed by three psychiatrists and one PhD in clinical psychology.
The intervention was held in six weekly sessions (one session per week for 90 min in each group). Intervention sessions were held by a Master of Science student in midwifery counselling, whom had completed a 60-hr life skills workshop and was performed under supervision of second author (F.E, Psychiatrist) and correspondent author (Z.Sh, Ph.D in Reproductive Health). The content of the sessions included education about the following topics: Breast cancer, Diaphragmatic breathing and progressive muscle relaxation technique, Cancer-related stressors, Stress management, Problem and emotion-focused coping strategies, Activation strategies, Social support and Spiritual coping strategies. Also, at the end of each session, participants were given a homework assignment to present their feedback in the next session. A summary of protocol content is presented in Table 1. Both intervention and control groups received routine care which included trainings by a chemotherapy nurse or oncologist about postchemotherapy physical and nutritional problems.

| Outcomes
The primary outcomes consisted of coping strategies and included PFC and EFC. These continuous variables were measured by Ways of Coping Questionnaire (WOCQ). The secondary outcome included stress. This continuous variable was evaluated by Depression-Anxiety-Stress Scale (DASS-21).

| Socio-demographic-clinical characteristics
This questionnaire consisted of questions about women's age, their spouse's age, number of children, level of education, marital status, employment status, duration of cancer, number of chemotherapy sessions, surgery type, stage of cancer, depression score, anxiety score and social support score. the validity of this questionnaire in Iranian context on women diagnosed with breast cancer and healthy samples were 0.39-0.65 and 0.57-0.8, respectively. Also, the Cronbach's alphas were 0.66 and 0.87 in above-mentioned groups, as well (Ahadi et al., 2014

| Depression-Anxiety-Stress Scale
Depression-Anxiety-Stress Scale questionnaire was introduced by Lovibond and Lovibond in 1995 (Lovibond & Lovibond, 1995). This instrument is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Scoring was based on Likert scale (0-3) and the range of total score was 0-42.
As the current scale is the short form of the main one (42 items), the total score of each subscale needed to be multiplied by two. Antony et al. reported a 0.94, 0.87 and 0.91 for Cronbach's alpha for depression, anxiety and stress, respectively (Antony et al., 1998;Asghari et al., 2008;Sahebi et al., 2005). This questionnaire was completed by all participants in both groups at the beginning of the present study.

| Medical Outcomes Study-Social Support Scale
To assess social support as a main covariate in coping strategies, the

| RE SULTS
Three participants withdrew from the intervention group in this study and data retrieved from 57 participants (27 participants in intervention group and 30 participants in control group) were finally analysed (Figure 1). There was no significant difference between the two groups in socio-demographic characteristics at the baseline ( was not significantly different in the two groups at the baseline. As shown in Table 4, these subscale scores were significantly decreased in intervention group compared with control group immediately after completing the intervention (p < .001) and one month after the intervention (p < .001). The effect size of the subscales varied from a moderate effect size for self-controlling subscale, a large effect size for escape-avoidance and to a very large effect size in the other subscales.  Table 5 show scores of PFC immediately after completing the intervention with the regression coefficient (β) increasing to 13.22 and in one month after the intervention increasing to a 12.76 (p < .001). Also, the score of EFC in intervention group decreased to 7.84 compared with control group (p < .001).

TA B L E 3
Mean score, standard deviation, effect size of coping and stress' scores, at the baseline, immediately and one month after the intervention a

Outcomes Time
Groups

Effect size (AMD) b
Problem-focused coping' score (total score ranged between 0-100) TA B L E 4 Mean score (out of 100), standard deviation and effect size of subscales of coping' scores at the baseline, immediately and one month after the intervention a

Outcomes Time
Groups

| D ISCUSS I ON
This study aimed to determine the effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer. This program statistically increased the PFC score and decreased EFC and stress scores in the intervention group compared with the control group that is in accordance with the previous studies (Behzadipoor et al., 2013;Kang & Oh, 2012;Loh & Quek, 2011;Shoaa Kazemi et al., 2013). It seems a wide variety of services are required to manage challenges surrounding cancer diagnosis, as well as the physical and emotional side effects of cancer treatment, problem-solving skills and stress management that can eventually lead to improvement in coping strategies; however, some studies have failed to demonstrate this concept (Cousson-Gelie et al., 2011;Ghahari et al., 2017;Hamilton et al., 2011). An explanation for this difference might be due to the time of intervention for example the previous studies conducted the intervention at the end of the chemotherapy and radiotherapy sessions (Ghahari et al., 2017;Hamilton et al., 2011) and at this stage patient has already coped with the new circumstances and the supportive program was not effective.
Another reason for the insignificance of the above studies could  Ghahari et al., 2017). In the present study, 57 patients were enrolled and intervention sessions were held for 90 min within six weeks.
Consistent with the literature (Allen et al., 2002;Carlson et al., 2013;Chen et al., 2018;Kang & Oh, 2012;Pelekasis et al., 2016;Sheikh Abumasoudi et al., 2015), this research found that supportive program by using breathing technique, relaxation and problem-solving strategies lead to reduction of stress score in women diagnosed with breast cancer. In this study, attempts were made to reduce the stress of participants by identifying sources of stress and practicing the techniques provided. However, the findings of the current study do not support the previous research (Orsak et al., 2015). This result may be explained by the type of intervention performed, the smaller number of intervention sessions (four sessions), the shorter duration (30 min) for each session and the limited sample size (15 women).
Another reason for the discrepancy was the lake of attention to psychiatric disorders. In this study, women with history of severe psychiatric disorders, hospitalization in the psychiatric ward, using psychiatric drugs, major depressive disorder and anxiety disorders were excluded from the study.

TA B L E 5
The results of the generalized estimating equations for the effects of supportive program on coping and stress

| Limitation
The random allocation of the samples, using the standard questionnaires and intervention based on a protocol designed by the research team could be mentioned as the strengths of the present study.
However, the study could not deal with many factors, including the individuals' perception of the disease and individuals' culture that are important in choosing the coping strategies and thus this was one of the limitations of the study. Another limitation of this study was that since patients were referred for chemotherapy on different days, patients from the two groups of intervention and control were more likely to meet and this issue may prone the study to contamination bias. Although this possibility is very small due to random sampling, two separate rooms in the chemotherapy ward the number of different chemotherapy sessions and receiving chemotherapy on different days. Due to non-masked design of this study at the participants and outcome assessor level, the results of this study might be prone to performance and detection biases.

| CON CLUS ION
In conclusion as in developing countries delivery of supportive care for breast cancer women is often a low priority (Cardoso et al., 2013;Ganz et al., 2013), it is important that healthcare professionals be provided with non-pharmacological interventions such as supportive programs to help breast cancer survivors in encountering with their new status. The results and protocol of this study can be used in practice to improve coping strategies and reduce stress in women with breast cancer. Empowering healthcare professionals with providing these services will offer patients alternative treatment methods.

ACK N OWLED G EM ENTS
The current article is part of a master's thesis by Elahe Samami, a master's student in midwifery counselling. This project was fully sup-

CO N FLI C T O F I NTE R E S T S
The authors have no conflicts of interest relevant to this article.

E TH I C A L A PPROVA L
This is a randomized controlled clinical trial, which has been registered obtained from all participants and they were ensured that their identity would be kept anonymous throughout the study. Participants, who voluntarily withdrew (in intervention group, N = 3) from the study, received routine care services as before.

DATA AVA I L A B I L I T Y S TAT E M E N T
Data are available on request due to privacy/ethical restrictions.