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

H. Setyowibowo, Marit Sijbrandij, A. Iskandarsyah, Joke A.M. Hunfeld, Sawitri Supardi Sadarjoen, Dharmayanti Badudu, D.R. Suardi, J. Passchier

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article number284
Pages (from-to)1-8
Number of pages8
JournalBMC Cancer
Volume17
DOIs
Publication statusPublished - 20 Apr 2017

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Indonesia
Randomized Controlled Trials
Breast Neoplasms
Education
Neoplasms
Breast
Health Education
Cause of Death
Therapeutics
Anxiety
Quality of Life
Depression
Pathology
Biopsy
Mortality

VU Research Profile

  • Human Health and Life Sciences

Cite this

@article{ec35d70b8502474f899f4183a6fffc80,
title = "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 registrationISRCTN12570738. Date: November 19th, 2016.",
author = "H. Setyowibowo and Marit Sijbrandij and A. Iskandarsyah and Hunfeld, {Joke A.M.} and Sadarjoen, {Sawitri Supardi} and Dharmayanti Badudu and D.R. Suardi and J. Passchier",
year = "2017",
month = "4",
day = "20",
doi = "10.1186/s12885-017-3268-7",
language = "English",
volume = "17",
pages = "1--8",
journal = "BMC Cancer",
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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. / Setyowibowo, H.; Sijbrandij, Marit; Iskandarsyah, A.; Hunfeld, Joke A.M.; Sadarjoen, Sawitri Supardi; Badudu, Dharmayanti; Suardi, D.R.; Passchier, J.

In: BMC Cancer, Vol. 17, 284, 20.04.2017, p. 1-8.

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - Setyowibowo, H.

AU - Sijbrandij, Marit

AU - Iskandarsyah, A.

AU - Hunfeld, Joke A.M.

AU - Sadarjoen, Sawitri Supardi

AU - Badudu, Dharmayanti

AU - Suardi, D.R.

AU - Passchier, J.

PY - 2017/4/20

Y1 - 2017/4/20

N2 - 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 registrationISRCTN12570738. Date: November 19th, 2016.

AB - 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 registrationISRCTN12570738. Date: November 19th, 2016.

U2 - 10.1186/s12885-017-3268-7

DO - 10.1186/s12885-017-3268-7

M3 - Article

VL - 17

SP - 1

EP - 8

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

M1 - 284

ER -