Condition category
Cancer
Date applied
04/11/2016
Date assigned
19/11/2016
Last edited
24/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Indonesia breast cancer is the most common cancer and the leading cause of cancer deaths among women. Delay in breast cancer diagnosis leads to a worse prognosis (outcome). Many Indonesian women with breast cancer are already at an advanced stage when they start treatment. Therefore, the delay in diagnosis has become a serious problem that needs to be addressed. The aim of this study is to find out whether a newly developed self-help psycho-educational programme, PERANTARA, reduces the delay of breast cancer diagnosis.

Who can participate?
Women aged 18 or older with breast cancer symptoms

What does the study involve?
In the first period the four participating hospitals are randomly allocated to deliver PERANTARA or treatment as usual. In the second period the hospitals cross over (swap) to deliver the other treatment. PERANTARA consists of both printed and audiovisual material that provides a brief explanation of breast cancer, treatment and its side effects, and a guide to a healthy lifestyle. In addition to regular medical procedures, treatment-as-usual is very limited and consists of incidental supportive talks with the nurses. Data is collected at the start of the study, 7 days after, and at 3 months follow-up. Diagnostic delay, breast cancer knowledge, anxiety, depression and quality of life are assessed.

What are the possible benefits and risks of participating?
Participants may benefit from expressing their thoughts, feelings and experiences about their health condition. Their participation will be useful to develop programs and tools to improve the quality of Indonesian women's health, especially those with breast cancer symptoms. Participants who receive PERANTARA may benefits from better understanding and adherence to the cancer treatment. There is no risk for participants’ physical health because it only requires answering some questions and reading the PERANTARA materials if they are allocated to PERANTARA. However, some of the information presented or questions asked by the research assistants may be distressing or uncomfortable, in which case additional support may be arranged. Information will be kept confidential and each participant will be anonymous.

Where is the study run from?
1. Rumah Sakit Al Ihsan Baleendah (Indonesia)
2. RSAU Salamun (Indonesia)
3. RSUD Cibabat (Indonesia)
4. RS Al Islam Bandung (Indonesia)

When is the study starting and how long is it expected to run for?
December 2013 to August 2018

Who is funding the study?
KWF, The Dutch Cancer Society (Netherlands)

Who is the main contact?
Mr Hari Setyowibowo
h.setyowibowo@unpad.ac.id

Trial website

Contact information

Type

Scientific

Primary contact

Mr Hari Setyowibowo

ORCID ID

http://orcid.org/0000-0001-5091-3180

Contact details

Jl. Gagak Barat No. 42 Sadang Serang
Bandung
40135
Indonesia
+62 (0)818 215 053
h.setyowibowo@unpad.ac.id

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KWF2012

Study information

Scientific title

A cluster-randomized controlled trial of a self-help psycho-education programme to reduce diagnosis delay in women with breast cancer symptoms in Indonesia

Acronym

PERANTARA

Study hypothesis

The aims of this study are to evaluate the effectiveness of PERANTARA in reducing the delay of breast cancer diagnosis in women who visit the hospital with the symptoms prior to formal diagnosis based on pathological examination.

Ethics approval

Ethics Review Committee of Hasan Sadikin Hospital, 23/12/2013, ref: LB.04.01/A05/EC/127/XII/2013

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Early stage breast cancer

Intervention

The study will be a multi-center, cluster randomized trial (cRCT), with hospitals as the unit of randomization (clusters). Four hospitals have agreed to participate in this study. Because of the limited number of hospitals, a cross-over design will be used in which each hospital will be given PERANTARA or treatment as usual (TAU) control at successive periods. This study uses two predefined periods. We will randomize the two hospitals on a 1:1 basis into either PERANTARA+TAU or TAU only. The two hospitals that are randomized into PERANTARA+TAU for the first period, will be assigned to TAU only for the second period and vice versa.

PERANTARA + treatment as usual
PERANTARA is a psycho-education material package that consists of both printed and audiovisual material. This package provides information and persuades the patients to follow doctors’ recommendations to prevent patient delay and facilitates them to improve the quality of the relationship with healthcare providers and her caregivers. The following information is provided in the material:
1. A brief explanation of breast cancer in order for the patients to have an accurate understanding and stimulation to seek information from reliable sources (oncologist)
2. Information on various kinds of breast cancer treatment and its side effects to inform the patients that the treatment may cause some side effects but they are all treatable so they don’t have to worry. It is also suggested that the patients to follow doctors’ recommendations regarding which treatment is best
3. Spirituality, to help the patients to employ a reframing coping strategy so they may see their conditions from a different point of view
4. Recommendation to seek social support to make them feel cared for
5. Guide to a healthy lifestyle to ensure the patients to stay healthy after receiving the diagnosis.

Treatment as usual only
In addition to regular medical procedures, treatment-as usual is very limited and consists of incidental supportive talks with the nurses.

Data will be collected at baseline (pre-assessment), 7 days after the intervention (post-assessment), and at 3 months (follow-up assessments). Total duration of treatment is 7 days and the follow-up time is three months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Diagnostic delay, defined as the number of days between the date of the first consultation at the hospital and the date of final breast cancer diagnosis based on pathological examination

Secondary outcome measures

1. Breast cancer knowledge measured using the Breast Cancer Knowledge Test (BCKT) at baseline, 7 days and 3 months after finishing PERANTARA
2. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 7 days and 3 months after finishing PERANTARA
3. Quality of life measured using the WHO Quality Of Life-BREF (WHOQOL-BREF) and the European Quality of Life 5D-5L at baseline, 7 days and 3 months after finishing PERANTARA

Overall trial start date

01/12/2013

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female outpatients who visit to the hospital with breast symptoms, suspected of having breast cancer
2. Age 18 years or older

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

106 patients

Participant exclusion criteria

1. Presence of major psychiatric disorders (presence of consultation history/record with the psychiatric department)
2. Inadequate command of the Indonesian language.

Recruitment start date

01/12/2016

Recruitment end date

31/08/2017

Locations

Countries of recruitment

Indonesia

Trial participating centre

Rumah Sakit Al Ihsan Baleendah
Jl. Kiastramanggala Baleendah
Bandung
40381
Indonesia

Trial participating centre

RSAU Salamun
Jl. Ciumbuleuit No.203 Ciumbuleuit Cidadap
Bandung
40142
Indonesia

Trial participating centre

RSUD Cibabat
Jl. Jend. H. Amir Machmud No.140 Cigugur Tengah Cimahi Tengah
Cimahi
40522
Indonesia

Trial participating centre

RS Al Islam Bandung
Jl. Soekarno-Hatta No. 644 RT. 001 RW. 001 Kel. Manjahlega Kec. Rancasari
Bandung
40286
Indonesia

Sponsor information

Organisation

KWF, The Dutch Cancer Society

Sponsor details

Delflandlaan 17
Amsterdam
1062EA
Netherlands
+31 (0)20 570 05 00
international@dutch-cancersociety.org

Sponsor type

Charity

Website

https://www.kwf.nl/english/pages/default.aspx

Funders

Funder type

Charity

Funder name

KWF Kankerbestrijding

Alternative name(s)

Dutch Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

31/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28427373

Publication citations

Additional files

Editorial Notes

24/04/2017: Publication reference added.