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

Abstract

BackgroundBreast 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.MethodsA 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.DiscussionIf 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-017-3268-7) contains supplementary material, which is available to authorized users.

Determinants of Breast Cancer Screening Practice among Women in Indonesia: A Nationwide Study

“…In Indonesia, a significant number of women are diagnosed for breast cancer in the advanced stage of the disease due to lack of knowledge and awareness, insufficient social support, numerous psychosocial factors, and, often times, the socio-characteristics of breast cancer patients (Setyowibowo et al, 2017;Anwar et al, 2018;Solikhah et al, 2020). A large-scale study in Ghana found that the educational background of a breast cancer patient is significantly associated with breast cancer screening (Agyemang et al, 2020).…”

A self‐help intervention for reducing time to diagnosis in Indonesian women with breast cancer symptoms

“…The study protocol has been published elsewhere . The study was approved by the Health Research Ethics Committee of Dr. Hasan Sadikin General Hospital in Bandung on 23 December 2013 (Document No: LB.04.01/A05/EC/127/XII/2013).…”

“…The inclusion criteria were as follows: (a) newly admitted female outpatients who visited the hospitals with BC symptoms before obtaining a definitive diagnosis; (b) age 18 years and older; (c) adequate command of the Indonesian language; and (d) no previous psychiatric consultations, as determined by medical records. Power calculations suggested a minimum sample size of 41 participants per group (power = 0.80, alpha = 0.05 two‐sided) . To account for 30% attrition at follow‐up, we aimed to include at least 106 participants (53 per group).…”

“…PERANTARA is a self‐help intervention that combines printed and audio‐visual health education and psychoeducation materials . The printed material covers three core themes: (a) “What is in my breast?,” providing a brief explanation of BC symptoms to promote an accurate understanding of BC and consulting a doctor as a credible source; (b) “Why should you immediately consult a doctor?,” offering a brief explanation of breast examination procedures to raise awareness about BC symptoms and increases motivation to follow diagnostic procedures; and (c) “You are not alone,” recommending to seek support from significant persons and institutions.…”

The role of psychosocial variables in breast self‐examination practice: Results from focus group discussions in Surabaya, Indonesia

“…Some previous studies in LMICs identified psychosocial factors as the primary obstacles in early detection, that is, low perceived benefit and self‐efficacy, high perceived barriers, a lack of breast cancer awareness, social taboos of cancer, misconceptions about cancer treatments, and beliefs in traditional medication 14,16 . Although some research on breast cancer early presentation in Indonesia exists, this was conducted among women with breast cancer symptoms 17 . There is as yet no research about the identification of potential beliefs that motivate BSE to achieve early presentation among women without breast cancer symptoms.…”