Community education and navigation to improve breast cancer screening uptake in Malaysia
| ISRCTN | ISRCTN15196866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15196866 |
| Secondary identifying numbers | 537084059 |
- Submission date
- 08/08/2022
- Registration date
- 10/08/2022
- Last edited
- 08/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer screening uptake in Malaysia is low and a high number of cases present at a late stage. Community navigation and mobile health (mHealth) may increase screening attendance, particularly by women from rural communities. This randomized controlled study evaluated an intervention that used mHealth and community health workers to educate women about breast cancer screening (i.e. clinical breast examination - CBE) and navigate them to CBE services in the context of the COVID-19 pandemic.
Who can participate?
The target population comprised residents from Sungai Segamat and Jabi who were recorded in the South East Asia Community Observatory (SEACO) database, completed the SEACO health survey in 2018, and, previously, gave consent to be contacted about participating in research studies. Thus, we contacted women aged 40-74 years who had registered their phone number with SEACO. Only women who had a mobile phone number via which they could be contacted were able to participate in the study. BC patients and survivors, and women who reported to the research team at the time of the interview that they were experiencing BC symptoms were excluded from the research and encouraged to seek help from their local doctor as soon as possible.
What does the study involve?
Women from the two sub-districts in the SEACO database were randomized to the intervention group (IG) or comparator group (CG) with a 1:1 allocation prior to being contacted. Women who were randomized to the IG received an intervention consisting of mHealth education and community navigation by community health workers (CHWs). CHWs called the women to whom they had been assigned during the same week that the baseline assessment interview had been completed to discuss breast cancer symptoms and breast self-examination, address barriers to screening, and ask them if they were interested in attending a CBE at the LPPKN clinic in Segamat. CBE appointments were arranged to occur the following week at a time that suited interested participants. CHWs discussed with participants who did not want to avail of the offer of screening their concerns and fears, but respected the decision of women who reiterated that they did not want to attend the CBE. Women with normal CBE results were asked by LPPKN nurses to attend screening biannually, either at the LPPKN or at a health clinic, as recommended in the clinical practice guidelines. A doctor at the LPPKN clinic met with women who received an abnormal CBE finding and referred them for a mammogram at the hospital as soon as possible after their CBE, free of charge.
The SEACO-trained data collectors contacted (via phone) women who were randomised to the CG - during this call, they informed women who agreed to participate that BC is the most common cancer amongst women in Malaysia and about the importance of early detection. Women in the CG did not receive the intervention (described above) but they could avail of ‘usual’ screening via their local clinic – however, elective procedures were stopped at the local government clinics to facilitate COVID-19 vaccinations and patients. In addition, CG participants were offered a scheduled free CBE at the LPPKN clinic after the follow-up data collection phase had been completed.
Information about gender, age, ethnicity, household income, marital status, education, occupation and study sub-district were extracted from the most recent health survey (2018) recorded in the SEACO database in order to present a profile of study participants. Participants were asked questions about mobile phone ownership/usage and internet usage during a baseline telephone survey. baseline and follow-up survey interviews were completed over the phone. Trained SEACO data collectors conducted telephone interviews with participants from the IG and CG that took approximately 15-20 minutes. The follow-up survey took between 20-25 min for the IG and 15-20 min for the CG. The survey interview comprised a number of previously adapted and validated questionnaires. LPPKN nurses were asked to record CBE attendance in a spreadsheet that was shared with SEACO on a weekly basis.
What are the possible benefits and risks of participating?
There were no immediate and direct benefits to participants; but the collected information will help to identify factors that may affect public awareness of breast cancer. Discussing and recollecting unpleasant feelings, fears, or worries about a sensitive topic such as breast cancer may have caused discomfort and distress. If participants felt upset at any stages of the study and wanted to talk about their concerns, we provided them with contact details of the Chief Investigator or encouraged them to call the National Cancer Society Malaysia hotline at 1800-88-1000. We do not expect any long-term risks associated with participating in a clinical breast examination.
Where is the study run from?
Queen's University Belfast (UK)
Monash Univerisity (Malaysia)
When is the study starting and how long is it expected to run for?
January 2021 to March 2022
Who is funding the study?
Newton Fund Impact Scheme which involved MRC from the UK and MIGHT from Malaysia.
Medical Research Council (UK) (Ref: 537084059) funded Prof Michael Donnelly as Principal Investigator on this project.
Malaysian Industry-Government Group for High Technology (MIGHT) (Ref: 2500235-122-00) funded Prof Tin Tin Su as Principal Investigator on this project.
Who is the main contact?
Prof. Michael Donnelly, michael.donnelly@qub.ac.uk
Prof. Tin Tin Su, TinTin.Su@monash.edu
Contact information
Principal Investigator
Centre for Public Health
Institute of Clinical Sciences
Block B, Royal Victory Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
 ORCID ID |
0000-0001-8380-7413 |
|---|---|
| Phone | +44 2890978993 |
| michael.donnelly@qub.ac.uk |
Principal Investigator
Monash University Malaysia
Jeffrey Cheah School of Medicine & Health Sciences
Jalan Lagoon Selatan
Bandar Sunway
Subang Jaya
47500
Malaysia
| ORCID ID |
0000-0003-0387-6406 |
|---|---|
| Phone | +603-5514 4472 |
| tintin.su@monash.edu |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Improving early detection of breast cancer in Malaysia during the COVID-19 pandemic - the use of mHealth to improve community education and navigation: a study protocol |
| Study acronym | CENP |
| Study objectives | Our main aim was to design, implement and evaluate an intervention to improve uptake of Clinical Breast Examination (CBE) screening in Malaysia and breast cancer symptom recognition in the context of the COVID-19 pandemic. |
| Ethics approval(s) | Approved 01/09/2021, Monash University Human Research Ethics Committee (Monash University, Malaysia; muhrec@monash.edu; +61 3 990 52052), ref: 29682 |
| Health condition(s) or problem(s) studied | Clinical Breast Examination (CBE) screening for breast cancer early detection |
| Intervention | This study was a randomised controlled trial and participants were randomised to either an intervention group (IG) or a control group (CG). Participant enrolment was conducted by trained data collectors. All women who were randomised to the IG or CG were invited to participate by trained data collectors over the phone. The resources for this study did not permit separation of enrollment and data collection procedures and, so, data collectors were aware of the group to which women were assigned. Participants and data collectors were not blinded during the enrollment and surveys. The IG received a multi-component mHealth intervention i.e. information about breast cancer was provided through an educational website, and telephone calls and text messages from community health workers (CHWs) raised breast cancer awareness and offered to navigate women to CBE services. The usual free opportunistic screening service was available for CG participants. It was not possible to ‘blind’ participants, data collectors and CHWs. |
| Intervention type | Behavioural |
| Primary outcome measure | Clinical breast examination (CBE) screening uptake measured using records from the LPPKN clinic at follow-up as well as self-reported data at baseline and follow-up. |
| Secondary outcome measures | 1. Breast cancer symptom recognition measured using the Breast Cancer Awareness Measure for Malaysia (B-CAM-M) at baseline and follow-up. 2. Intention to attend a CBE measured using the question ‘I intend to have a Clinical Breast Examination to check for breast cancer in the near future’ and a 5-point Likert scale for participants to rate their response at baseline and follow-up. 3. Beliefs and barriers regarding breast cancer and breast cancer screening measured using the Breast Cancer Awareness Measure for Malaysia (B-CAM-M) at baseline and follow-up. 4. Practice of breast self-examination measured using the Breast Cancer Awareness Measure for Malaysia (B-CAM-M) at baseline and follow-up. 5. Mammogram screening attendance (for CBE-positive women) measured using LPPKN clinic records at follow-up. |
| Overall study start date | 03/01/2021 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 932 |
| Total final enrolment | 483 |
| Key inclusion criteria | 1. Residents from Sungai Segamat and Jabi (Malaysia) who were recorded in the South East Asia Community Observatory (SEACO) database, completed the 2018 SEACO health survey and have previously given consent to be contacted about participating in other research studies. 2. Women aged 40 - 74 years 3. Registered a phone number with SEACO. Only women who were able to provide a mobile phone number when contacted were able to participate in the study. |
| Key exclusion criteria | 1. Breast cancer patients and survivors. 2. Women who reported to the researchers at the time of the interview that they are experiencing breast cancer symptoms were excluded from the research and encouraged to seek help from their local doctor as soon as possible. |
| Date of first enrolment | 02/09/2021 |
| Date of final enrolment | 14/11/2021 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Kampung Abdullah
Segamat District, Johor
85000
Malaysia
Jalan Muar
Segamat District, Johor
85000
Malaysia
Sponsor information
University/education
University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
| Phone | +44 28 9024 5133 |
|---|---|
| cph@qub.ac.uk | |
| Website | http://www.qub.ac.uk/ |
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
No information available
Government organisation / National government
- Alternative name(s)
- The Newton Fund, NF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings of our study will be disseminated to LMICs through publications and presentations at conferences as well as to advocacy groups and stakeholder groups and professional networks in Malaysia. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (South East Asia Community Observatory; mum.seaco@monash.edu; quantitative data; available from 01/01/2023 until 01/01/2028; information on how to request data can be found here: https://www.monash.edu.my/seaco/research-and-training/how-to-collaborate-with-seaco; participants consented for their data to be analysed anonymously for research purposes, identifying information will kept strictly confidential by only using SEACO ID numbers). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (other) | 18/01/2022 | 09/08/2022 | No | No | |
| Results article | 05/10/2023 | 08/11/2023 | Yes | No |
Editorial Notes
08/11/2023: Publication reference added.
09/08/2022: Trial's existence confirmed by Monash University
