A self-help psycho-education programme to reduce diagnosis delay in women with breast cancer symptoms in Indonesia
| ISRCTN | ISRCTN12570738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12570738 |
| Secondary identifying numbers | KWF2012 |
- Submission date
- 04/11/2016
- Registration date
- 19/11/2016
- Last edited
- 20/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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 years 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
Contact information
Scientific
Jl. Gagak Barat No. 42 Sadang Serang
Bandung
40135
Indonesia
 ORCID ID |
0000-0001-5091-3180 |
|---|---|
| Phone | +62 (0)818 215 053 |
| h.setyowibowo@unpad.ac.id |
Study information
| Study design | Cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | Ethics Review Committee of Hasan Sadikin Hospital, 23/12/2013, ref: LB.04.01/A05/EC/127/XII/2013 |
| 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 |
| Primary outcome measure | 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 study start date | 01/12/2013 |
| Overall study end date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 106 patients |
| Total final enrolment | 132 |
| 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 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
Study participating centres
Baleendah
Bandung
40381
Indonesia
Ciumbuleuit
Cidadap
Bandung
40142
Indonesia
Cigugur Tengah
Cimahi Tengah
Cimahi
40522
Indonesia
RT. 001 RW. 001
Kel. Manjahlega
Kec. Rancasari
Bandung
40286
Indonesia
Sponsor information
Charity
Delflandlaan 17
Amsterdam
1062EA
Netherlands
| Phone | +31 (0)20 570 05 00 |
|---|---|
| international@dutch-cancersociety.org | |
| Website | https://www.kwf.nl/english/pages/default.aspx |
"ROR" |
https://ror.org/0368jnd28 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Dutch Cancer Society, Koningin Wilhelmina Fonds, DCS, KWF
- Location
- Netherlands
Results and Publications
| Intention to publish date | 31/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/04/2017 | Yes | No | |
| Results article | results | 06/01/2020 | 12/02/2020 | Yes | No |
| Statistical Analysis Plan | 06/01/2020 | 20/12/2023 | No | No |
Editorial Notes
20/12/2023: Statistical analysis plan added.
12/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
24/04/2017: Publication reference added.
