Setyowibowo et al.

BMC Cancer (2017) 17:284

DOI 10.1186/s12885-017-3268-7

STUDY PROTOCOL Open Access

A protocol for a cluster-randomized

controlled trial of a self-help psycho-
education programme to reduce diagnosis
delay in women with breast cancer
symptoms in Indonesia
Hari Setyowibowo1,2*, Marit Sijbrandij2, Aulia Iskandarsyah3, Joke A. M. Hunfeld4, Sawitri S. Sadarjoen3,
Dharmayanti F. Badudu5, Drajat R. Suardi5 and Jan Passchier2

Abstract
Background: Breast cancer (BC) is the most frequent cancer occurring in women across the world. Its mortality rate
in low-middle income countries (LMICs) is higher than in high-income countries (HICs), and in Indonesia BC is the
leading cause of cancer deaths among women. Delay in breast cancer diagnosis negatively impacts cancer
prognosis. Only about 30% of patients who come to the hospital to check on their breast abnormalities, continue
thorough examination to biopsy to get a diagnosis based on the results of anatomical pathology. Many Indonesian
women with breast cancer were already in an advanced stage when starting treatment. Therefore, delay in
diagnosis is a serious problem that needs to be addressed. The present study will investigate whether our newly
developed self-help psycho-educational programme, “PERANTARA”, for women with breast cancer symptoms is
effective to reduce patient diagnosis delay in Indonesia.
Methods: A cluster-randomized controlled trial will be conducted in 106 patients in four hospitals in Bandung,
West Java, Indonesia. Data will be collected at baseline (pre-assessment), 7 days after the intervention (post-
assessment), and at 3 months (follow-up assessments). The primary outcome is delay in diagnosis and treatment.
Secondary outcomes are breast cancer knowledge, anxiety and depression, and quality of life. Exploratively,
adherence with treatment will be measured too. Data will be analysed by hierarchical linear modelling (HLM) to
assess differential change over time.
Discussion: If proven effective, PERANTARA will be evaluated and implemented in a diversity of settings for local
cares (such as in POSYANDU, PUSKESMAS) that provide health education/psycho-education for women with breast
symptoms.
Trial registration: ISRCTN12570738. Date: November 19th, 2016.
Keywords: Breast cancer, Delay in diagnosis, Psycho-education, Self-help, Indonesia

* Correspondence: [email protected]
1
Department of Educational Psychology, Faculty of Psychology, Universitas
Padjadjaran, Bandung, Indonesia
2
Clinical, Neuro-and Developmental Psychology, Faculty of Behavioural and
Movement Sciences, VU University, Amsterdam, the Netherlands
Full list of author information is available at the end of the article

© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
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Setyowibowo et al. BMC Cancer (2017) 17:284 Page 2 of 8

Background of awareness and inadequate knowledge about symp-

Breast cancer (BC) is the most frequent cancer occurring toms and treatment of BC [11, 14, 15]. It is crucial that
and the leading cause of cancer-related deaths in the information that is provided by the medical staff, is
women, with an estimated 1.67 million new cancer cases both informative and acceptable to patients.
diagnosed and 522,000 deaths in 2012 [1]. The incidence A cross-sectional study in 70 breast cancer patients in
of breast cancer in LMICs is lower as compared to HICs Indonesia showed also that many breast cancer patients
(25.8 vs 95 per 100.000), but a major concern in LMICs in Indonesia were not satisfied with the information they
is the higher mortality despite its lower incidence (12.7 received [16]. The study showed that most patients were
vs 17.1 per 100.000) [2]. In Indonesia, BC is the most dissatisfied with the information about social support.
prevalent cancer among women with an incidence rate Furthermore, the study found also that most of the pa-
of 48,9 and a mortality rate of 19,8 women per 100,000 tients were dissatisfied with the amount of written infor-
[3]. mation. Therefore, the use of clear, concise, and easy to
One of the reasons for the high mortality of breast understand educational materials (e.g.: leaflets, posters,
cancer in LMICs is the fact that most cancer in LMICs flipcharts table, visualized story telling) may be effective
is detected at later stages. Review on delay of diagnosis and efficient in complementing the verbal information
revealed that more than 70% of breast cancer patients in that is usually provided by the oncologists at the oncol-
most HICs are diagnosed in Stages I and II, compared ogy clinic. The utilization of educational material may
with only 20 to 50% of patients in the majority of LMICs be a solution to overcome the lack of resources (e.g. : ex-
[4]. In Indonesia, about 60%–70% of patients had their perts, time and finance) and can be given by a face-to-
first BC-related visit to the hospital when the disease face breast health education, either individually or in
was already in advanced stages (III and IV) [5–7]. groups.
Diagnosis delay, the time between seeking medical ad- Numerous psycho-educational interventions have been
vice and the date of final diagnosis based on pathological designed for women (affected by) with breast cancer (or
examination (i.e. biopsy), remains a serious problem. breast cancer symptoms) in response to the need for
Studies have shown that diagnosis delay of over 3 psychological support and health behavior education. A
months is associated with a bigger tumour size, positive randomized controlled trial (an experimental pretest-
lymph nodes, high incidence of late clinical stages, and posttest control group design) involving 76 women with
metastatic disease [8, 9]. Delay in diagnosis predicts BC in Turkey comparing a psycho-education program to
worse clinical outcomes [10]. The delay may cause mor- treatment as usual reported that the psycho-educational
tality of the patient. A previous qualitative study involv- program (which consisted of eight 90 min weekly ses-
ing 50 BC patients in Indonesia found that 35 sions on basic information about breast cancer, nutri-
participants (70%) were delayed in seeking help, with the tion, psychosocial factors, interpersonal skills, problem
time of delay ranging from 4 to 24 months, except for solving, experience sharing and support) led to positive
the four participants who had delayed for 4 years, changes in levels of adjustment to cancer [17]. In that
10 years, 3 years, and 15 years, respectively [11]. study, the psycho-educational group had higher levels of
Previous studies found that delay in diagnosis among fighting spirit, lower levels of helplessness/hopelessness,
women with breast cancer symptoms was a result of a anxious preoccupation and fatalism, both at 6 weeks and
complex interaction of several factors, which often con- 6 months after the intervention. However, there were no
cern characteristics of the patients and the health care changes in the levels of avoidance/denial compared to
system. Several studies state that patients-related factors the control group. Another study (one group pre-post
are a major concern and need to be addressed in an test design) carried out in early-stage BC patients in Italy
intervention program (e.g. lack of knowledge and aware- found that a psycho-educational intervention was feas-
ness about breast cancer). For example, a study in Mo- ible and useful to enhance coping strategies in patients
roccan women found that diagnosis delay is also a very [18]. An RCT that evaluated the efficacy of a psycho-
important health problem in Moroccan women, particu- educational intervention (an individualized fatigue edu-
lary caused by a lack of knowledge, information and cation and support program delivered in the clinic and
awareness regarding breast cancer [12]. by phone over three 10- to 20-min sessions 1 week
As diagnostic delay is a serious problem, efforts to re- apart) in improving BC-related fatigue compared to gen-
duce delay are necessary. Improving knowledge of eral cancer educational sessions (equivalent in number
women, via training and involving physicians and other and timing to the sessions that were provided for the
healthcare providers, seems to be an effective approach intervention group) suggests that women who received
to reduce delay in the diagnosis of breast cancer [13]. the intervention received some short-term benefit in
The delay to consult a doctor for seeking help after the terms of minimization of the intensity and impact of fa-
discovery of the symptoms is most likely caused by lack tigue on daily life [19]. A systematic review and meta-
Setyowibowo et al. BMC Cancer (2017) 17:284 Page 3 of 8

analysis to evaluate the effectiveness of psychosocial and we will use a cross-over design in which in each hospital
especially psycho-educational support interventions for will be given PERANTARA or control (treatment as
early-stage breast cancer patients showed that these in- usual (TAU)) at successive periods. Because every hos-
terventions were effective in increasing emotional well- pital forms its own control, the cross-over design can
being [20]. An intervention study that aimed to assess produce results with a smaller sample size than required
the effectiveness of psycho-education on well-being sta- with a parallel design. The order in which the hospital
tus and depression among Malaysian BC patients using receives PERANTARA is randomly determined. The
cluster non-randomized trial design found that group study will compare the PERANTARA to TAU in women
psycho-education not only significantly improved breast with suspected breast cancer. This study uses two prede-
cancer survivors’ well-being status but also reduced de- fined periods. In the first period, two hospitals will have
pression level [21]. the experimental group (the patient is given the inter-
Web-based programs are a promising new way to offer vention and TAU) and two other hospitals will have the
psycho-educational interventions to patients and their control group (patients only receive TAU). In the second
caregivers [22], but several patient groups in Indonesia period, it is the other way around.
have no access to it, particularly patients with low edu- The primary outcome is diagnosis delay in terms of
cation, low socio-economic status (SES) and those in the time between the date of the first consultation at the
rural areas. Currently in Indonesia, printed and on-line hospital and the date of final breast cancer diagnosis
information materials about BC have been provided by based on pathological examination. Secondary outcomes
hospitals, the Ministry of Health and a number of foun- are breast cancer knowledge, anxiety and depression,
dations or communities. However, these sources of in- and quality of life, as well as treatment delay.
formation appeared to not have achieved an optimal
impact either, due to the lack of capacity to access them, Participants
particularly for patients with low socio-economic status This study will include 106 patients in the cRCT, 53 par-
(SES) in rural areas. Meanwhile, the information that is ticipants in the Treatment-as-Usual (TAU) control group
accessible to the wider public (TV, radio, and newspa- and 53 participants in the experiment/intervention
pers) often contains promotion of traditional healing group. Power calculations suggest a minimum sample
methods which even can make patients hesitant in fol- size of 41 participants per group (power = 0.80, alpha =
lowing the process of examination (and possible treat- .05 two-sided). Taking into account 30% attrition at
ment) at the regular hospital. follow-up, at least 106 participants (53 per group) need
Summarizing, several educational interventions for to be included. Participants will be recruited from four
breast cancer patients exist, but these focus mainly on district hospitals in Bandung, West Java, Indonesia, that
coping with cancer. Interventions which focus on the re- are representative for the health care facilities in the dif-
duction in diagnosis delay, are less common, and absent ferent areas in Bandung, Indonesia.
in Indonesia. Therefore, an educational program to dimin- Participants will be new patients (outpatients) who
ish diagnosis delay can be of paramount importance for visit the hospital with breast symptoms, which make
reducing morbidity and death. For this purpose, we devel- them suspects of having breast cancer. Patients eligible
oped a psycho-educational intervention (‘PERANTARA’) for the intervention program will be asked to take part
focused on reducing diagnosis delay. in the study when reporting at the district hospitals. The
The aim of this study is to evaluate the effectiveness of following inclusion criteria will be used: women with
PERANTARA in reducing the delay of breast cancer diag- age > 18 years, an adequate command of the Indonesian
nosis in women who visit the hospital with BC symptoms language and no major psychiatric disorder. The last is
prior to formal BC diagnosis based on pathological exam- determined by checking the medical record on a con-
ination. As a secondary aim, we studied its effect on breast sultation history/record with the Psychiatric Depart-
cancer knowledge, anxiety and depression, and quality of ment. Patients who have been seen by psychiatrists are
life. Finally, we explored the effects on the longer term, excluded from the study.
also regarding the treatment delay.
Procedure
Methods The healthcare professionals (oncologist or nurse) will
Design inform eligible participants about the study (see Fig. 1).
The study will be a multicentre, cluster-randomized con- The research assistant will follow up to inform the pa-
trolled trial (cRCT), with hospitals as the unit of ran- tients about the details of the study and asks them for
domisation (clusters). We will include four hospitals in oral and written informed consent. Patients who agree
Bandung, Indonesia that have agreed to participate in to participate will be asked to fill in: (1) the socio-
this study. Because of the limited number of hospitals, demographic and medical history form, (2) the World
Setyowibowo et al. BMC Cancer (2017) 17:284 Page 4 of 8

Diagnostic Delay Questionnaire; Quality of Life (2)

WHOQOL-Bref and (3) EQ-5D 5L; (4) HADS; (5)
BCKT. The researcher will review the medical record of
the patient to registrate the occurence of treatment
delay. This period is chosen because it is also a criterion
for treatment delay.
Trained research assistants with a background of
psychology will conduct the assessments. All research
assistants have received a 5-days workshop covering
how to administer the instruments, information on com-
mon psychosocial needs of breast cancer patients, gen-
eral interview techniques, and how to take a neutral role
instead of a therapeutic role. Ongoing monitoring will
be conducted through regular supervision by the main
researcher (HS) supervised by the principle investigators.

Intervention
The ‘PERANTARA’ is a self-help psycho-education
material package that consists of both printed and au-
diovisual material (see Table 1). The word PERAN-
TARA is Indonesian for ‘mediator’ or ‘facilitator’.
PERANTARA is abbreviation for “Pengantar PERAwa-
taN kesehaTan payudARA”, which means ‘introduc-
tion to breast health treatment’. The conceptual
framework (blueprint) of PERANTARA was developed
based on semi-structured interviews with 27 breast
cancer patients and 5 focused group discussion ses-
sions with healthcare providers (5 oncologists and 15
Fig. 1 Flowchart of The Procedure
nurses). The conceptual framework (blueprint) was
then reviewed by a panel consisting of a health
Health Organization Quality of Life - Assessment Bref psychology expert, a healthcare communication ex-
(WHOQOL-BREF), (3) the European Quality of Life-5 pert, an oncologist, and a breast cancer survivor. The
Dimensions-5 Levels (EQ-5D-5 L), (4) the Hospital researchers obtained suggestions and comments on
Anxiety-Depression Scale (HADS) Questionnaire, (5) the the intervention blueprint and also the usability and
Breast Cancer Knowledge Test (BCKT). Participants acceptability of the developed interventions. The
who are illiterate will be giving an oral consent and a panel also recommended to have the printed and au-
thumb print in lieu of a signature, in line with recom- diovisual material be developed by a team of audiovi-
mendations from WHO [23]. sual professionals. The PERANTARA provides the
Participants in the control group will receive treatment following information: 1) a brief explanation of breast
as usual (TAU), while the intervention group will receive cancer in order for the patients to have an accurate
the PERANTARA package (which consists of printed understanding and stimulation to seek information
and audiovisual materials). Participants will be requested from reliable sources (oncologist); 2) an explanation
to read and watch the intervention package within of the breast examination procedure to raise the pa-
7 days. tients’ awareness on their symptoms and willingness
The post-intervention assessment will take place 7 days to follow this procedure; 3) recommendation to seek
after the intervention. Participants will be asked to fill in support from significant persons and institutions. The
the following questionnaires: (1) the Diagnostic Delay audiovisual material is an 8 min and 33 s length
Questionnaire; Quality of Life (2) WHOQOL-Bref and video featuring two breast cancer survivors who
(3) EQ-5D 5L; (4) HADS; (5) BCKT; (6) Intervention shared their stories about their conditions, promoting
Material Feedback Form. active coping and seeking social support.
The follow up assessment will be scheduled at The prototype of PERANTARA was piloted within 13
3 months (12 weeks) after the post-intervention assess- patients and with oncologists and survivors. Results
ment. The Participant will be requested to fill in: (1) The from this pilot study showed that the prototype was
Setyowibowo et al. BMC Cancer (2017) 17:284 Page 5 of 8

Table 1 Overview of PERANTARA Package

feasible and acceptable to use. Trained research assis- at all four hospitals participated in the study. The re-
tants will give the PERANTARA to the experimental search assistants will keep track of all services received
groups. They will give a brief explanation to the patient by the patients during the course of the study.
regarding PERANTARA and instructions on how to
use it. Instruments
Primary outcome
Treatment as usual (TAU) Diagnosis delay will be the primary outcome measure.
TAU in a district hospital usually consists of consult- This is defined as the time between the date of the first
ation with the oncologist about the medical examination consultation at the hospital and the date of the definite
procedures. Information related to breast health is lim- breast cancer diagnosis based on pathological examin-
ited, and usually entails nothing more than a poster on ation. This outcome will be measured using the Diag-
the wall in the hospital waiting room. Psychosocial ser- nostic Delay Interviewer Guide. This instrument has
vices for patients with breast complaints to support the been developed by the researchers and consists of the
patient during the examination process are not provided following questions: (a) What was the date that you
Setyowibowo et al. BMC Cancer (2017) 17:284 Page 6 of 8

consulted with a doctor in the hospital?, (b) What was validity and reliability for measuring the quality of life
the date that you received the breast cancer diagnosis?, among the elderly [26]. We will also use the EQ-5D 5L
and if there was a consult delay (c) What were the rea- to measure health-related quality of life [27]. EQ-5D 5L
sons for delay? A distinction will be made between delay is based on a descriptive system that defines health in
due to the patient and due to the doctor. This tool will terms of 5 dimensions: mobility (MO), self-care (SC),
be pilot-tested before the final data collection is done. usual activities (UA), pain/discomfort (PD), and anxiety/
depression (AD). Each dimension has 5 levels: no prob-
Secondary outcome lems, slight problems, moderate problems, severe prob-
A standard socio-demographic and medical history form lems, and extreme problems/unable. This descriptive
(SDMH) will be used to collect patients’ background system is then followed by a self-rating of overall health
data on ethnicity, age, marital status, religion, education status on a visual analogue scale (EQ - VAS) ranging
level, employment status, income level, travel time to from 0 (“the worst health you can imagine") to 100 (“the
hospital, insurance status, mental health status, family best health you can imagine"). EQ-5D 5L has been
history of cancer and use of traditional healer. The pa- validated in diverse patient populations in numerous
tients’ medical records will also be reviewed to obtain countries [28]. The official Bahasa Indonesia version
data on type and stage of cancer and type of treatment. of the EQ-5D 5L will be used; provided by the Euro-
Patient knowledge will be assessed using the Breast Qol Group [29].
Cancer Knowledge Test (BCKT). The BCKT is a 20-item Feedback from participants on the intervention mater-
questionnaire that was developed and tested to deter- ial package will be measured using The Intervention
mine (a) general knowledge of breast cancer; and (b) the Material Feedback Form. This instrument has been de-
relationship between the knowledge of breast cancer and veloped by the researchers. Finally, treatment delay will
utilization of screening practices. The BCKT consists of be measured at the follow-up measurement by asking
2 subscales; one subscale of 12 items to measure general the patient with a positive diagnosis if she has started
knowledge and one subscale consisting of 8 items to her treatment at the hospital. This will also be checked
measure knowledge of curability. In the first section, with the hospital records.
item number 3 about the breast cancer prevalence was
adjusted with the actual Indonesian prevalence rate. The
Analysis plan
total score ranged from 0 to 20, with higher scores indi-
Demographic characteristics will be summarized using
cating higher breast cancer knowledge. The BCKT has
descriptive statistics, including percentages for categor-
an acceptable reliability coefficient (α = 0.69). The Breast
ical data, and means and standard deviations for con-
Cancer Knowledge Test (BCKT) has been translated into
tinuous data. The descriptive statistics will be tabulated
Indonesian using the forward-backward translation
and presented graphically. Hierarchical linear modeling
method [24].
(HLM) will be employed to evaluate potential changes in
Symptoms of anxiety and depression will be measured
the Diagnostic Delay Questionnaire scores over time. In
with the Hospital Anxiety and Depression Scale (HADS).
this study, a three level model will be used with repeated
The HADS is a 14-item self-report questionnaire that
measures nested in person, and persons nested in clus-
was developed to assess psychological distress in people
ters. Time (pre, post, follow-up) will be considered as
with medical illness. It consists of 2 subscales: 7 items to
level 1, the individual persons will be considered as level
measure anxiety (HADS-A) and 7 items to measure de-
2 and the clusters (intervention-control group) will be
pressive symptoms (HADS-D). Psychometric properties
considered as level 3. HLM analysis using a similar
of the Indonesian version of the HADS were adequate,
model will also be carried out to evaluate potential
with values of Cronbach’s coefficient (alpha) being 0.77
changes in the scores of secondary outcomes: Quality of
and 0.74, respectively [13].
Life (WHOQOL-BREF and EQ-5D 5L), HADS, and
Quality of life will be measured using the WHOQOL-
BCKT respectively. HLM analysis will be carried out
BREF ([25]; in the Indonesian version with a 4 week-
separately for each phase before and after crossover.
time frame). This tool is a self-report questionnaire that
Demographic variables will be entered as additional
consists of 26 items and each item represents one facet
predictors including SES, educational levels, and
of life that is considered to have a contribution to a per-
patients’ locations to explore potential impact on the
son’s quality of life. Two items measure quality of life
effect of the interventions.
and health satisfaction in general. Twenty-four items
measure four broad domains, namely physical health (7
items), psychological health (6 items), social relation- Ethics
ships (3 items) and environmental (8 items). The The project has been approved locally by the Health Re-
WHOQOL-BREF has been validated, and indicates high search Ethics Committee of Dr. Hasan Sadikin General
Setyowibowo et al. BMC Cancer (2017) 17:284 Page 7 of 8

Hospital Bandung on December 23rd, 2013, Document Those who agreed will be asked to sign the form. The study does not
No: LB.04.01/A05/EC/127/XII/2013 (Additional file 1). expect any negative effects; however if participants feel uncomfortable, they
can cancel or withdraw their participation at any time. In case the participant
is illiterate or has difficulties, the trained research staff will help her to
Discussion comprehend the study and other related issues.
Delivering self-help psycho-education materials, expli-
citly aimed at diagnosis delay – like our PERANTARA - Publisher’s Note
may be an effective way to offer psycho-educational in- Springer Nature remains neutral with regard to jurisdictional claims in
terventions. Therefore, this study has been designed to published maps and institutional affiliations.
evaluate the effectiveness of self-help psycho-education Author details
materials in reducing the delay of breast cancer diagno- 1
Department of Educational Psychology, Faculty of Psychology, Universitas
sis in women who visit the hospital with BC symptoms Padjadjaran, Bandung, Indonesia. 2Clinical, Neuro-and Developmental
Psychology, Faculty of Behavioural and Movement Sciences, VU University,
prior to formal BC diagnosis based on pathological Amsterdam, the Netherlands. 3Department of Clinical Psychology, Faculty of
examination. If proven effective, PERANTARA will be Psychology, Universitas Padjadjaran, Bandung, Indonesia. 4Department of
evaluated and implemented in a diversity of settings of Psychiatry, section Medical Psychology and Psychotherapy, Erasmus MC
University Medical Center, Rotterdam, the Netherlands. 5Department of
primary care (such as in PUSKESMAS, POSYANDU), Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.
which provide health education/psycho-education for
women with breast symptoms who are liable to BC diag- Received: 13 January 2017 Accepted: 5 April 2017
nosis delay.
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