Breast Neoplasm FemalemBLISS-BNCT06293508
mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public
A study testing Standard Health Communication Intervention and Behavioural Change Health Communication Intervention in people with Breast Neoplasm Female, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial summary
Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy… Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Standard Health Communication Intervention and Behavioural Change Health Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Apr 2024to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Malaysian women aged 40 years and above
- Possess a smartphone with the predetermined social messaging application (derived from Phase 1 of study) installed.
- Have not been diagnosed with cancer before.
Who cannot join
- Underwent Clinical Breast Examination in the past 12 months.
- Mammogram screening in the past 2 years.
- Subjects who are deemed to have cognitive impairment and unable to provide consent to the study.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Institute for Clinical Research, National Institutes of Health, Malaysia
Shah Alam, Selangor, 40170
About this study
Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,
Based on this promising prospect, a randomized controlled trial will be designed to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. The investigators hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group.
Read the detailed description
This study involves a randomized controlled trial to asses the effectiveness of a health communication program using specifically designed materials using behavior science and behavior change principles. Materials were designed based on findings derived from a scoping review and interviewing Malaysian women through a series of qualitative interviews to determine the barriers and facilitators of attending breast cancer screening. The interview also investigated women's preferences for certain characteristics in a health message and health communication program that would motivate them to attend screening.
Participants in the main experimental group will be compared with a control group, and another group which undergoes a standard health communication program.
- Conditions
- Breast Neoplasm Female
- Being tested
- Standard Health Communication Intervention, Behavioural Change Health Communication Intervention
- Keywords
- mHealth, breast cancer screening, behaviour, health communication, randomised controlled trial, behaviour change communication, persuasive communication, social messaging
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Health Communication InterventionBehavioural
Participants in this group will receive links and materials related to breast cancer screening from official sources (e.g. MOH, Non-governmental organizations (NGOs), etc.) that is already readily available and accessible by the Malaysian public. Frequency, duration, and platform of dissemination will be based on findings from Phase 1 of this study.
Behavioural Change Health Communication InterventionBehavioural
Participants receive health communication materials designed using persuasive behavioural change communication principles and behavior science to promote breast cancer screening. Frequency, duration, and platform of dissemination will be based on findings from Phase 1 of this study.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants do not receive any message throughout the study period. |
| Experimental Arm 1 | Experimental | Participants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp. Receives: Behavioral: Standard Health Communication Intervention |
| Experimental Arm 2 | Experimental | Participants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp. Receives: Behavioral: Behavioural Change Health Communication Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).
Self-reported attendance of breast cancer screening
Measured: 2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Secondary outcomes (4)
Health literacy level
Scored via a validated instrument
Measured: At baseline
Perception based on domains in Health Belief Model
Scored via a validated revised Champion Health Belief Model Scale instrument
Measured: 3 time points: Baseline, 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Perceived acceptance and usefulness of health communication program
Scored via a validated instrument
Measured: 3 months after 6 month intervention period has ended.
Reasons behind participants not participating in breast cancer screening.
Determined via a multiple choice question
Measured: 2 time points: Baseline, and 3 months after 6 month intervention period has ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start30 Apr 2024
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Why it stopped: Project was halted due to administrative complications arising while seeking for a vendor to assist with subject recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia, National University of Malaysia, Institute for Health Behavioral Research, Malaysia
- Responsible party
- Principal investigator, Nicholas Hing Yee Liang, Clinical Research Centre, Malaysia
- Investigators
- Nicholas Yee Liang Hing, MSc, Principal investigator, Institute for Clinical Research, National Institutes of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293508
- Sponsor's protocol ID
- NMRR ID-22-02616-I2I
- Acronym
- mBLISS-B
- Status last verified
- Nov 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public
- ClinicalTrials.gov ID
- NCT06293508
- Acronym / sponsor ID
- mBLISS-B / NMRR ID-22-02616-I2I
- Conditions
- Breast Neoplasm Female
- Keywords
- mHealth, breast cancer screening, behaviour, health communication, randomised controlled trial, behaviour change communication, persuasive communication, social messaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project was halted due to administrative complications arising while seeking for a vendor to assist with subject recruitment.
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia, National University of Malaysia, Institute for Health Behavioral Research, Malaysia
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,
Based on this promising prospect, a randomized controlled trial will be designed to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. The investigators hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group.
Detailed description
This study involves a randomized controlled trial to asses the effectiveness of a health communication program using specifically designed materials using behavior science and behavior change principles. Materials were designed based on findings derived from a scoping review and interviewing Malaysian women through a series of qualitative interviews to determine the barriers and facilitators of attending breast cancer screening. The interview also investigated women's preferences for certain characteristics in a health message and health communication program that would motivate them to attend screening.
Participants in the main experimental group will be compared with a control group, and another group which undergoes a standard health communication program.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants do not receive any message throughout the study period. |
| Experimental Arm 1 | Experimental | Behavioral: Standard Health Communication InterventionParticipants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp. |
| Experimental Arm 2 | Experimental | Behavioral: Behavioural Change Health Communication InterventionParticipants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Malaysian women aged 40 years and above
- Possess a smartphone with the predetermined social messaging application (derived from Phase 1 of study) installed.
- Have not been diagnosed with cancer before.
Key exclusion criteria (3 listed)
- Underwent Clinical Breast Examination in the past 12 months.
- Mammogram screening in the past 2 years.
- Subjects who are deemed to have cognitive impairment and unable to provide consent to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Health Communication InterventionParticipants in this group will receive links and materials related to breast cancer screening from official sources (e.g. MOH, Non-governmental organizations (NGOs), etc.) that is already readily available and accessible by the Malaysian public. Frequency, duration, and platform of dissemination will be based on findings from Phase 1 of this study. | Behavioural | Experimental Arm 1 |
| Behavioural Change Health Communication InterventionParticipants receive health communication materials designed using persuasive behavioural change communication principles and behavior science to promote breast cancer screening. Frequency, duration, and platform of dissemination will be based on findings from Phase 1 of this study. | Behavioural | Experimental Arm 2 |
Primary outcome
Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).
Time frame: 2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Self-reported attendance of breast cancer screening
4 secondary outcomes
Health literacy level
Time frame: At baseline
Perception based on domains in Health Belief Model
Time frame: 3 time points: Baseline, 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Perceived acceptance and usefulness of health communication program
Time frame: 3 months after 6 month intervention period has ended.
Reasons behind participants not participating in breast cancer screening.
Time frame: 2 time points: Baseline, and 3 months after 6 month intervention period has ended.
Results and safety
The study was stopped early (reason given: Project was halted due to administrative complications arising while seeking for a vendor to assist with subject recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. No plans to share IPD.
Related trials for Breast Neoplasm Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Yee Liang Hing, MSc principal investigator
Institute for Clinical Research, National Institutes of Health, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Health Communication Intervention and Behavioural Change Health Communication Intervention in people with Breast Neoplasm Female, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Project was halted due to administrative complications arising while seeking for a vendor to assist with subject recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram). (time frame: 2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.