Web-based app to raise awareness of breast and cervical cancer screening
| ISRCTN | ISRCTN10403163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10403163 |
| Secondary identifying numbers | FRGS/1/2020/SKK05/UPM/02/5 |
- Submission date
- 23/11/2021
- Registration date
- 24/11/2021
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast and cervical cancers are the two most common cancers among women in Malaysia.
Although screening has contributed significantly to reducing deaths due to these cancers in other countries, this has not been the case in Malaysia. Women still present with late-stage disease and very few attend screening, even when screening is offered for free or at hugely discounted rates. Our goal is to develop an interactive web app to promote early detection for breast and cervical cancers in Malaysian women and to determine the impact of the web app on the intention to uptake screening.
Who can participate?
Women aged 20 years and above and married or have a partner (sexually active), or aged 50-75 years old, regardless of previous/current sexual activities will be invited to participate in the study.
What does the study involve?
The participants will answer a questionnaire on the intention of breast and cervical cancer screening, awareness on breast and cervical cancer, and barriers to help-seeking as well as using the web-based MAwar app.
What are the possible benefits and risks of participating?
The possible benefits of the study included improved early detection of breast and cervical cancer among women in Malaysia and allow contribution to the development of an intervention to improve early detection of breast and cervical cancer which contribute to the larger body of medical knowledge in the field of cancer prevention and early detection. There is minimal risk involved in this study as the participants will only need to answer some questions that are related to using the application and about their intention to attend cancer screening which does not provoke any unpleasant feelings or any unnecessary concern to them. If any of the participants express worry about the potential outcome of the assessments, they will be counselled by the clinic’s registered nurse.
Where is the study run from?
Ministry of Higher Education, Malaysia
When is the study starting and how long is it expected to run for?
May 2021 to April 2024
Who is funding the study?
This study was funded by Fundamental Research Grant Scheme, Ministry of Higher Education, Malaysia
Who is the main contact?
Prof Dr Sazlina Shariff Ghazali, sazlina@upm.edu.my
Contact information
Scientific
Department of Family Medicine
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
UPM Serdang, Selangor
43400
Malaysia
 ORCID ID |
0000-0002-5737-7226 |
|---|---|
| Phone | +60 122325659 |
| sazlina@upm.edu.my |
Study information
| Study design | Quasi-experimental pre-post study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pre-post quasi-experimental study |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effectiveness of an interactive web application to motivate and raise awareness on screening of breast and cervical cancers (The MAwar study) |
| Study acronym | MAwar |
| Study objectives | 1. The Web app is a useful tool to be used in clinical practice to improve intention to uptake on cervical cancer and breast cancer screenings. 2. The Web app could significantly improve the intention to uptake on cervical cancer and breast cancer screenings among women. |
| Ethics approval(s) | Approved 04/05/2021, Medical Research Ethics Committee Ministry of Health, Malaysia (National Institute of Health, No.1, Jalan Setia Murni U13/52, Section U13 Bandar Setia Alam, 40170 Shah Alam, Selangor, Malaysia; +603-33628888/ 33628205; mrecsec@moh.gov.my) ref: NMRR-21-951-58339 (IIR) |
| Health condition(s) or problem(s) studied | Screening for breast and cervical cancers |
| Intervention | Participants will be systematically recruited. Eligible and agreed participants will use a web-based application called MAwar app upon recruitment. Primary and secondary outcomes will be measured at 3 and 6 months after being introduced to the web-based application. |
| Intervention type | Behavioural |
| Primary outcome measure | Intention for screening will be measured using the using the stages of readiness to go for screening that will be adopted from the Transtheoretical Model Stages of Change (Prochaska & DiClemente, 1984; Krok-Schoen et al., 2016) at baseline, 3 and 6-months follow up |
| Secondary outcome measures | 1. Awareness of breast cancer risk factors will be measured using the Breast Cancer Awareness Measure at baseline, 3 and 6-months follow up (Cancer Research UK, 2014; Linsell et al., 2010; Htay et al., 2020). 2. Awareness on cervical cancer risk factors will be measured using measured using the Cervical Cancer Awareness Measure (Cancer Research UK, 2014; Simon et al., 2012) at baseline, 3 and 6-months follow up |
| Overall study start date | 04/05/2021 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 650 |
| Key inclusion criteria | Women aged 20 years and above and married or have a partner (sexually active), OR aged 50-75 years old, regardless of previous/current sexual activities |
| Key exclusion criteria | 1. Those on regular follow up for breast and/or cervical cancer screening 2. Those who attended the health clinics to investigate for symptoms or signs related to cervical or breast cancers 3. Age 20 years and above with painless lump, persistent rash around nipple, bleeding or unusual discharge from nipple, changes of skin (swollen, dimpling, puckering), nipple retraction, 4. Age 30 years and older with history of benign breast disease with atypical hyperplasia 5. Does not reside in Klang District 6. Acutely ill patient |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Klang
42000
Malaysia
Kawasan 10
Klang
42000
Malaysia
Kawasan 15
Klang
41300
Malaysia
Sponsor information
Government
Research Fund Secretariat
IPT Excellence Planning Division
Department of Higher Education
Level 7, No. 2, Tower 2, Jalan P5/9, Precinct 5
Putrajaya
62200
Malaysia
| Phone | +603-8000 8000 |
|---|---|
| 80008000@mygcc.gov.my | |
| Website | https://www.mohe.gov.my/utama://ufm.dk/ |
"ROR" |
https://ror.org/05mcs2t73 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
15/08/2022: The intention to publish date has been changed from 31/10/2023 to 30/03/2025.
12/08/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/02/2022 to 01/09/2022.
2. The recruitment end date has been changed from 31/08/2022 to 31/01/2023.
3. The overall trial end date has been changed from 31/03/2023 to 30/04/2024 and the plain English summary updated accordingly.
24/11/2021: Trial's existence confirmed by Medical Research Ethics Committee Ministry of Health, Malaysia.
