A Self-Help Guided Psychoeducational Intervention for Indonesian Women with Breast Cancer Symptoms: Development and Pilot Feasibility Study

Background: Delay in the diagnosis of breast cancer (BC) may lead to an advanced stage of the disease and a poor prognosis. A psychoeducational intervention can be crucial in helping women with BC symptoms complete the examination procedures and reduce diagnosis delay of BC. Objective: To develop a psychoeducational intervention to reduce the delay of BC diagnosis among Indonesian women with BC symptoms. Methods: The development of the intervention included an inventory of crucial elements in developing psychoeducation through literature review as well as consultation with BC patients and healthcare providers. Additionally, we developed PERANTARA as the first pilot version of the self-help guided psychoeducational intervention. PERANTARA is an abbreviation for “Pengantar Perawatan Kesehatan Payadura”, which means an introduction to breast health treatment. The pilot feasibility study combined an expert review and a pilot testing in hospital settings. A semi-structured interview and the client satisfaction inventory were utilized to measure feasibility and acceptability of the intervention for Indonesian women with BC symptoms. Results: PERANTARA contained an oncologist’s explanation about BC and the BC survivors’ testimony to reduce the time to diagnosis. The pilot study results showed that most patients were satisfied with and trusted on PERANTARA. Conclusion: PERANTARA was feasible and acceptable for Indonesian patients with BC symptoms. The development framework suggested in this study can be applied to develop psychoeducational packages for other patients group, in particular, those interventional packages aimed at reducing diagnosis and treatment delays and non-adherence.


Introduction
well as miscommunication between patients and health care providers that may hinder the process of scheduling and obtaining the diagnostic tests (Caplan, 2014;Unger-Saldana, 2014;Freitas and Weller, 2015).
Time to diagnosis, the interval time between the first clinical consultation and the time that BC is diagnosed and confirmed by the doctor, is critical in BC management (Caplan et al., 1996;Barber et al., 2004;Redaniel et al., 2015;Abu-Helalah et al., 2016). In Indonesia, about 60-70% women with BC appear to be already in an advanced stage (stage III-IV) when starting their treatments (Ministry of Health of the Republic of Indonesia, 2016). Furthermore, there is a fact that around 67% of women with BC symptoms who visit a hospital to consult for their breast abnormalities, tend to not continue with a thorough examination to obtain a definitive diagnosis (Sander, 2011). Therefore, promoting breast cancer awareness and adequate medical help-seeking behavior is essential for women at risk of BC to facilitate early diagnosis and treatment process and to achieve better prognosis (Khan et al., 2015;Denny et al., 2017).
A qualitative study on 50 Indonesian women with BC found that delay in seeking help and non-adherence to treatment were associated with lack of awareness and knowledge, patient's perception about cancer as a dangerous deadly disease, believing cancer is incurable, emotional burden, unmet information needs, and trust in traditional healers. One of the crucial findings signified that most women described BC as a deadly and incurable disease, trusting on information obtained from stories and BC experiences of their relatives and neighbors, or mass media sources (e.g., magazines, newspapers, and television) (Iskandarsyah et al., 2014a;Iskandarsyah et al., 2014b;Azhar et al., 2016). Consequently, interventions to reduce time to diagnosis are needed to encourage women with BC symptoms to receive medical treatment immediately to achieve a better prognosis.
A cross-sectional study on 70 women with BC in Indonesia discovered that many of patients (41-86%) were not satisfied with the amount of written information about BC that they received (Iskandarsyah et al., 2013). Therefore, the use of concise and understandable educational materials (e.g., leaflets, posters, flipcharts table, and visualized storytelling) may complement the verbal explanations usually provided by the health care providers at clinics. Furthermore, the implementation of educational materials may be an appropriate solution in overcoming the lack of resources (e.g., experts, time, and finance).
To the best of our knowledge, evidence-based guided self-help psychoeducational interventions to reduce time to diagnosis are still lacking in Indonesia. Therefore, we developed PERANTARA, a self-help psychoeducational program, aiming at reducing the time to diagnosis. In the current study, we described the development of PERANTARA. we also reported a pilot study on its feasibility and acceptability for women with BC symptoms residing in Indonesia .

Materials and Methods
The development of PERANTARA consisted of three steps: 1) Inventory, 2) Intervention development, and 3) Pilot study See Figure 1, p 257.

Inventory
A narrative literature review was conducted as an inventory step to ensure psychoeducation as a potential psychosocial intervention option for helping women with BC-related complaints, identify crucial elements for the intervention development, and to discover important issues or psychoeducation needs for women with BC symptoms. A narrative literature review is used to provide a comprehensive background to understand the current knowledge and highlight the importance of the new research (Cronin et al., 2008).
Furthermore, we conducted semi-structured interviews with women with BC (n= 27) and Focus Group Discussion (FGDs) with oncologists (n=5) and nurses (n=15) in the Hasan Sadikin Hospital Bandung. The patients' age ranged from 30 to 69 years old. Fifteen (56%) patients had completed elementary school or had lower level of education. Nineteen (70%) patients were housewives or unemployed. Twenty-five (93%) patients were married, and the remaining two patients were widows. Twentysix (96%) patients had health insurance provided by the government for people with low income, which was less than 2 million rupiahs a month. Both the interviews and FGDs addressed the following questions: (1) What would be a feasible way to tackle the reported diagnostic delay and adherence barriers? (2) Who should, can, and would you like to be involved in developing and implementing the interventions? (3) For which populations is it necessary to develop an intervention program?, and (4) What is a possible format of the intervention?

Intervention development
For developing PERANTARA, we involved experts from the field of health psychology, health communication, oncology, and audiovisual design. Three BC survivors were engaged in providing suggestions for the content, format, and utilization of the intervention packages. The intervention development comprised of the following two main activities:

1) Conducting FGD
FGDs with an oncologist, a health communication expert, two health psychology experts, and two BC survivors were held to review the intervention framework. The FGDs focused on the following issues: (1) The target population; (2) The person who delivers the contents; (3) The contents of the psychoeducation; (4) The delivery method; and (5) The delivery location.

2) Developing PERANTARA
One of the authors (HS) organized a series of collaborative work to develop the first pilot version of the psychoeducation package. The process started by writing a script as a guide to develop PERANTARA. After that, he collaborated with the audiovisual communication Afterward, we compared the original English version and the back-translation of the questionnaire to identify any discrepancies. After discussing any possible discrepancies, we achieved consensus and finalized the Indonesian version of the CSQ-8 that fitted the context of the use of PERANTARA. In this current study, the modified CSQ-8 achieved an acceptable reliability coefficient (α=.80).
We conducted open-ended interviews to obtain patients' feedbacks on the intervention packages. The interviewer addressed the following questions: (1) How do you feel about this intervention package? (2) What is your opinion about the testimonies/stories conveyed by the survivors and the explanations conveyed by the doctors in this intervention package? (3) What is your opinion about the presentation of this intervention package (fonts, language, and image)?.

Data-analysis
The data from were analyzed qualitatively based on the Theoretical Thematic Analysis, a method for identifying, analyzing, and reporting patterns (themes) within data (Braun and Clarke, 2006). To analyze the qualitative data, we used a qualitative software program (NVIVO version 11.40). We first transcribed the interviews and FGDs. Two authors (HS and AI) created a coding directory independently (created nodes in NVIVO). After that, the nodes were compiled into main themes and presented in a coding matrix. The coding matrix was discussed until an agreement on the framework was achieved. Then, the verbatim material was coded and analyzed independently. Discussion meetings were organized to compare analyses, adapt the coding matrix and main themes, and analyze the data again before an agreement was met. Frequencies and percentages of participants mentioning a theme were calculated, and typical citations were noted. Descriptive statistics were used to describe participants and to summaries feedback on the intervention (using percentage).

Inventory
As shown in Table 1, we retrieved 13 papers reporting research on psychoeducational interventions for a population that had psycho-social problems related to BC. In the papers we reviewed, the interventions were targeted at women with BC instead of focusing on women who were still uncertain about whether they had BC or not. Several methods to deliver psychoeducational programs were applied, both the self-help using psychoeducational material (written materials, audiovisual materials) as well as group delivery of psychoeducation. The psychoeducational programs were meant to increase knowledge on BC, increase satisfaction with information of BC and the treatment, reduce cancer worry, increase quality of life in women affected by BC, increase risk perception, and improve adjustment to BC diagnosis. According to findings of these studies, psychoeducation can be a potential psychosocial intervention option to help women with BC-related complaints. In addition, printed material and audiovisual materials can be the alternative designers to prepare the printed material. The procedure included illustration drawing, layout making, lettering, and printing. In addition, he also cooperated with the audiovisual communication designer to develop the audiovisual storytelling. The process itself entailed video shooting, voice overtaking, music composing, animating motion graphic, and burning the DVD.

Pilot study Participant
PERANTARA was pilot-tested on 13 patients to evaluate its feasibility for delivering in a controlled trial (Setyowibowo et al., 2017) and to gather preliminary information on its acceptability by patients. We recruited participants from Klinik Padjadjaran in Sumedang, West Java, Indonesia. The patients' age ranged from 18 to 61 years old. Eight (62%) patients were women with BC symptoms, and five (38%) patients were women with BC. Five (38%) patients had completed elementary school, six (42%) patients had completed high school, and two (15%) had completed college level. Eight (62%) patients were housewives or unemployed. Nine (69%) patients had income less than 2 million rupiahs a month. Eight (57%) patients had health insurance provided by the government for people with low income. One patient refused to fill out a questionnaire after providing with the package of interventions because she underwent BC treatment one day before data collection and felt tired to continue the study.

Procedure
Eligible patients were invited to the hospital, informed about the details of the study, and oral and written informed consent was obtained from each of them. Patients who agreed to participate filled out the socio-demographic and medical history form, read and watched the intervention package, filled out the questionnaire , and responsed to the interview questions. This study was reviewed and approved by the Health Research Ethics Committee of Dr. Hasan Sadikin General Hospital Bandung (RSHS) on December 23rd, 2013 (Document No: LB.04.01/A05/ EC/127/XII/2013).

Instruments
A standard socio-demographic form was distributed to collect patients' background data on ethnicity, age, marital status, religion, education level, employment status, income level, medical status, and insurance status. To assess feasibility and acceptability, we used the modified version of the Client Satisfaction Questionnaire (CSQ)-8 to fit the context of the use of the psychoeducation intervention (PERANTARA) in Indonesia. The original CSQ-8 has eight questions assessing the global client's satisfaction in a clinical setting (Larsen et al., 1979;Matsubara et al., 2013). The patients respond to those items using a 4-point Likert scale, and the total scores range from 8 to 32. Higher scores indicate greater satisfaction. We applied the forward-and back-translation method to modify the CSQ-8. First, we translated the questionnaire from English to Indonesian, and then we translated it back into English.  At 6 months, group psychoeducation increased MACS subscales "fighting spirit," (p = .000), and decreased "helplessness/hopelessness" (p = .000), "anxious preoccupation" (p = .000) and "fatalism" (p = 0.000).   (7) Possible barriers. The primary results per theme are described below.
1) Target population. Most of the BC patients (23 patients, 82.5%) recommended that the psychoeducational program should also be given to their caregivers (spouse, Figure 1. Intervention Development Framework family, or their significant other). The healthcare providers (oncologists and nurses) also agreed that the psychoeducational program should be targeted at the caregivers too.
2) The content of the intervention. The patients stated that they needed to get more information from the experts regarding (a) breast cancer and it's treatment (27 patients, 100%), (b) coping strategies and spirituality (25 patients, 92.6%), (c) nutrition and diet (16 patients, 59.3%), and (d) healthcare facilities and financial support (9 patients, 33,3%). The healthcare providers mentioned that patients needed to have sufficient understanding of their illness, so that these patients would immediately call for medical help and comply with the examination/diagnostic and treatment procedures.
3) Delivery method. Many participants (20 patients, 74.1%) believed that the delivery method should be interactive as well as informative using group discussion or individual consultation. Some of the patients (n= 14, 51.9%) suggested that psychoeducation materials, written and audiovisual, could be used as supplementary tools as long as they contained expert explanations and displayed visually attractive pictures but not too frightening ones. Several patients (n=7, 25.9%) suggested using the internet, even though they realized that some patients would need other people to help them in accessing the information on the internet. 4) Delivery agent (Facilitator). Both patients and healthcare providers agreed that healthcare provider should be delivery agents (facilitator). They mentioned that this might be a task of an oncologist (16 patients, 59.3%) and a nurse or a midwife (15 patients, 55.6%). Despite the fact that most of the patients understood that their oncologist or doctor had limited time to deliver the intervention, they still considered the oncologist as the key delivery agent.
5) The time frame of delivery. Both healthcare providers and patients recommended using this program when they were visiting the healthcare institution, at the first breast symptom before breast cancer diagnosis (19  7) Possible barriers. More than half of the patients (14 patients, 51,9%) considered their psychological conditions (anxiety, stress, fatigue) as potential barriers to engage in the intervention program. Some of the patients reported their financial problems (7 patients, 25.9%) and lack of communication facilities (3 patients, 11,1%) as potential obstacles against engaging in the intervention program. Approximately a quarter of the patients (8 patients, 29.6%) considered some characteristics of the care provider (communication skills, a limited amount of expert time and consultation ) as possible challenges in the development and implementation of the intervention program. The care providers had a similar perspective toward these barriers. Moreover, they added that the educational / knowledge level of the patient was also important when developing and implementing an intervention program.

Theme
Sub Theme Usability How do you feel after using the PERANTARA?
Helpful. Patients feel that PERANTARA is helpful because: improve their knowledge and awareness to continue the examination so that his complaint is promptly diagnosed and treated, and reduces anxiety and doubts to continue the examination and treatment. Patients feel that this intervention package is useful so they will recommend this package to others.
Motivating. Patients feel motivated to use this package because it is attractive. Also, they also feel motivated to continue the examination and treatment after getting an explanation from the doctor and testimony from survivors in this package.

Source of Information
What is your response to information provided by BC survivors and oncologists?
Survivor. Patients feel that the true story of the BC Survivors found in the PERANTARA stirred their feelings because the women who have been diagnosed with cancer still have high spirits to undergo the process of examination and treatment. Also, they also feel touched because it turns out BC Survivor can still live their lives every day without feeling isolated. Therefore, they suggested that the survivors' profiles could be added in the package.
Oncologist. Oncologist's advice was helpful and easy to understand. Patients stated that information about the diagnosis of breast cancer and its treatment was helpful knowledge. Also, information on risk factors and preventive action is valuable.

Presentation
What is your opinion regarding the presentation/display of the PERANTARA? Use past tense to present patients' opinions. I mean all you have written in the column named sub theme should be in past tense.
Clarity. The language and images that used make the information more understandable. Patients recommend that fonts in the bubbles be enlarged and critical statements written in bold fontss. Attractiveness. The images and colors used make the PERANTARA more interesting and not boring. Alternatively, patients suggest using photos.  Part 3. Why should immediately consult a Doctor? A stimulation to let the first breast examinations immediately be followed by a biopsy so that the disease can be diagnosed and treated early; and a brief explanation of breast examination procedure to raise the patient's awareness on the their symptoms and willingness to follow the procedure.
Part 4. You are not alone. Information showing that many people are around who care; Recommendation to seek support from significant persons and institutions. Target Population Female patients with breast cancer symptoms (that can be presumed as related to breast cancer during the first visit to a hospital). Demographic Status: middle to low level of education status, middle to low level of socio-economic status, live in the urban and rural area.
Behavior Objective Reduce patient's delay (Time to Diagnosis)

Short Description
The testimony of two survivors of breast cancer who shared their stories about their conditions, promoting active coping and seeking social support, and give recommendation to patients to consult a doctor immediately when they discover abnormalities in their breast.

Intervention Development
The process of developing PERANTARA begins with FGDs involving an oncologist, health psychologists, a health communication expert, and BC survivors. The following were the results of the FGDs: 1) Who was the target population? The panel recommended patients as the target population of the psychoeducational intervention. Depending on the specific behavioral objective, interventions were delivered to the patient during her first visit to the hospital after finding BC symptoms, after BC diagnosis, or during treatment. Moreover, the caregiver was also considered to receive psychoeducation because the caregiver's support would influence a patient's health behavior.
2) Who should deliver the content? Potential psychoeducational intervention agents included oncologists, nurses, midwives, psychologists, social workers, or BC survivors. The oncologist was considered more credible due to his medical background, while the BC survivor was regarded more acceptable because of her experiences.
3) What were the contents? The psychoeducational program should provide both a simple scientific and medical explanation of BC symptoms and psychosocial support in order to stimulate the patients to immediately undergo the examination (diagnostic). This would enhance quick diagnose and treatment of the disease. 4) How to deliver the content? The selection of the delivery method was chosen according to demographic characteristics of the target population (middle-low education level, middle-low social, and economic status). Further, the limited availability of healthcare professionals and consultation time within the hospital was regarded. Therefore, the intervention was self-help, and support by practitioners was limited. Furthermore, the panel also recommended the use of attractive printed and audiovisual materials. 5) Where to deliver the program? Some locations were considered as potential places to deliver the psychoeducational package, including hospital, first line health services, and community activity center.
Based on these recommendations, the first author wrote a script (intervention blueprint) as guidance in developing an intervention package (PERANTARA). Critical elements in the intervention blueprint included title, format, language, target population, behavior objective, and main themes. (See Table 2. Intervention Blueprint). Based on this script, the PERANTARA package was developed with an audiovisual communication designer. The prototype was discussed with each of the research group members and, based on their feedback, the first pilot version of PERANTARA package was finalized.

Pilot Study Qualitative Analysis
As demonstrated in Table 3 (Patient's Opinion), patients stated that PERANTARA package was valuable and motivated them to undergo the medical procedure. Patients believed that the explanation given by the oncologist in PERANTARA was understandable and helpful. Furthermore, the patients stated that the narrative approach in presenting the information and utilization of a variety of images made PERANTARA clear and attractive

Quantitative Analysis
As shown in Table 4 (Client's Satisfaction Inventory), the large majority of patients (n=9; 75%) appeared to be satisfied with the help they had received from PERANTARA. According to patients, the quality of PERANTARA was good (n=8; 66,7%) and met their Scene (Key Message) 1) Introduction. Sample script: "This is a true story of the struggles of two tough women, ever since they discovered any abnormalities in their breasts, until successfully through various challenges during the treatment process. Now, they are still actively working for the community and beloved family." 2) Reduce delay. Sample script: "If we find the things that are suspicious, or anything different than usual, consult with a doctor or other health professionals, to assure what the problem is..." "Do not be too scared first because not all lumps are cancer. The important thing is consult to the doctor immediately to know the examination procedures." 3) Coping with psychosocial issues. Sample script: "...When you go through the process of examination and treatment, probably will emerge feeling sad and lonely. You do not have to worry too much, because you are not alone. Many care about you! Ask your husband, family or friends to accompany you. Share stories, feelings and expectations need to be done..." "...My message to the family, especially to her husband, the emotional support to a spouse or who are undergoing examination or treatment of breast cancer is very important. Without the support of the husband, their spirit will fall."

4) Contacts
Important list of address to gain support: informational, financial and emotional.  50%). Furthermore, we found that patients obtained the information they needed (n=6; 50%) and PERANTARA helped them to cope with their problems more effectively (n=7; 58,3%). Moreover, patients stated that they were willing to continue using PERANTARA (n=7; 58,3%) and to recommend this intervention packages to a friend who would need similar help (n=10; 83,3%).

Finalization
Based on the results of the pilot study, we made some revisions in the content and presentation of PERANTARA (Setyowibowo, 2017) . These revisions were made following consultation with an oncologist, a health communication expert, a health psychology expert, and BC survivors. The revisions were: 1) The printed materials were adapted (adapted in a form of Table Flipchart (See Table 5). The content of table flipchart consisted of: (1) What's in my breast? a brief explanation of BC symptoms to enable patients to have an accurate understanding and motive them to seek help from oncologists as a reliable sources; (2) Why should I immediately consult a doctor? This part aimed to stimulate women to follow the examination procedure as soon as possible so that the disease can be diagnosed and treated as early as possible and to raise the patient's awareness on her symptoms; and (3) You are not alone: the recommendation to seek support from significant persons and institutions is provided.
2) Audiovisual materials . We added brief summaries of the key messages given in the printed materials. Besides, we also added a profile photo of an oncologist and BC survivors to increase the credibility of the information sources. See Table 5 (Final Script) for the final outline of PERANTARA.

Discussion
In this study, we explained the process for the d e v e l o p m e n t o f P E R A N TA R A , a s e l f -h e l p psychoeducational material for Indonesian women with BC symptoms. Its development was an iterative process involving patients (women with BC symptoms, women with BC, and BC survivors), healthcare providers (nurses and oncologists), and a multi-disciplinary group (health psychologist, health communication, and audiovisual designer). First, we interviewed the patients since they were the potential target group for our intervention. Furthermore, we involved experts from various fields and BC survivors to review the intervention framework that we had designed based on the results gained in the inventory step. This was done since we had to consider the resources to develop and evaluate the intervention.
The PERANTARA development was based on data collected from previous studies investigating psychoeducational interventions in other populations. We found that using printed and audiovisual materials could be a potential option to deliver psychoeducation to women with BC-related complaints, especially when resources were limited in terms of money, facilities, and experts to provide face-to-face or group psychoeducation.
A strength of PERANTARA is the use of narrative storytelling to educate and to persuade women with BC symptoms to immediately undergo the examination process so that the disease can be immediately diagnosed and treated. The use of narratives is emerging as a strategy to educate, persuade, and prompt health behavior change. Some previous studies reported that delivery of health information through the use of narratives was intrinsically persuasive Kreuter et al., 2010;Dahlstrom, 2014) and more acceptable for patients with low and adequate health literacy (Moran et al., 2016) and populations that had a strong oral tradition (Hinyard and Kreuter, 2007), such as Indonesia. It is noteworthy to mention that PERANTARA contained information about both medical and psychosocial issues related to BC symptoms and diagnosis procedure. It aimed to reduce diagnostic delays and to support patients with BC symptoms. Evaluation of the content by a BC survivor, an oncologist, and a health psychologist confirmed that the information was relevant for women with BC symptoms. A limitation of this study was that we included a small sample of women with BC and BC symptoms who may not represent the larger population of women with BC symptoms in Indonesia. Therefore, we recommend conducting a clinical trial in order to evaluate the efficacy of PERANTARA in reducing the time to diagnosis of Indonesian women from the moment they discover BC symptoms.
The results indicated that most of the women with BC and BC symptoms who participated in the pilot study had positive reactions toward the intervention package and were willing to recommend PERANTARA to new patients with BC (symptoms).
This study provided a useful framework to develop and pilot test a newly psychoeducational intervention. Given that the results of the ongoing crossovercontrolled trial were positive, our intervention can be applied within standard oncological care in Indonesia. With some adaptation, the PERANTARA might also be suitable for women diagnosed with BC who had delayed their treatment. Moreover, the development process of PERANTARA, as described in this study, can be used as a future template to develop psychoeducational materials for other patient groups. Future studies are recommended to develop some psychoeducational interventions to help the caregiver of BC patients to cope with their psychosocial challenges.

Statement conflict of Interest
The authors declare that they have no competing interests.