Breast CancerNCT06869759
"Effectiveness of Community Health Workers in Breast Cancer Prevention in Jumla: a Cluster Randomized Trials
A study testing Implementation strategy - Health Promotion and Education-based intervention in people with Breast Cancer and Prevention, run by Karnali Academy of Health Sciences at 1 site in Nepal.
Trial summary
Breast cancer is the second most prevalent cancer among Nepali females, accounting for 17.1% of cases and 7.7% of female cancer-related deaths. It is more common in younger, premenopausal women, often diagnosed at advanced stages. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prevention
- What is being tested?
- Implementation strategy - Health Promotion and Education-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNepal
- Study dates
- 25 Aug 2024to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married women >= 20 years of age group women of CNMP Jumla,
- FCHV, those who can read, write, and understand, and
- ANM
Who cannot join
- Married women >= 20 years age group women who had a positive existing case,
- Pregnant and lactating women of CNMP Jumla,
- FCHV those who cannot acquire the minimum skill of breast self-examination,
- ANM who untrained for BSE.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Karnali Academy of Health Sciences, Jumla, Karnali, Nepal
Jumla, Karnali
About this study
Official title: Effectiveness of Community Health Workers Induced Prevention of Breast Cancer by Community Health Promotion and Education Implementation Strategies in Jumla - a Cluster Randomised Controlled Trial
Breast cancer is the second most prevalent cancer among Nepali females, accounting for 17.1% of cases and 7.7% of female cancer-related deaths. It is more common in younger, premenopausal women, often diagnosed at advanced stages. Raising awareness through community education is crucial for promoting breast cancer screening, particularly in low-resource settings like Nepal, where clinical breast exams are essential early detection tools. Integrating breast cancer education into the health system can enhance knowledge, encourage screening, and promote healthy behaviors for prevention. Early detection significantly improves treatment outcomes and survival rates.
In remote areas, limited access to advanced detection technologies makes breast self-examination (BSE) the most feasible and cost-effective method, particularly in Jumla. This study evaluates the effectiveness of community health worker-led breast cancer prevention through health promotion and education strategies. It follows PROCTOR's framework and the Health Belief Model (HBM) A mixed-methods design will be employed, incorporating an embedded implementation science approach, a cluster-randomized trial, and mixed-method research. The study population includes married women of Jumla, female community health volunteers (FCHVs), and auxiliary nurse midwives (ANMs). Exclusion criteria include married women ≥20 years old with existing cases of cancer, pregnant or lactating women, FCHVs unable to acquire BSE skills, and untrained ANMs. The sample consists of 90 participants in both intervention and control groups.
Read more
Acceptability, Appropriateness, and Feasibility will be assessed using the Acceptability of Intervention Measure (AIM) tool. SOP-based checklists will evaluate fidelity, while FGDs and KIIs will collect qualitative data. Quantitative data will be analyzed using frequency, percentage, mean, and standard deviation. A paired t-test and mixed-effect linear regression will assess effectiveness, while qualitative data will undergo thematic analysis. Findings will be reported per CONSORT guidelines.
Ethical approval will be obtained from the Nepal Health Research Council. Expected outcomes include improved breast cancer knowledge, perception, and screening intention, leading to early detection and reduced prevalence. However, selection bias in cluster trials may limit generalizability.
- Conditions
- Breast Cancer, Prevention
- Being tested
- Implementation strategy - Health Promotion and Education-based intervention
- Keywords
- Health Promotion and Education Strategies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation strategy - Health Promotion and Education-based interventionBehavioural
Firstly, three broad strategies will be implemented in the intervention arm (use of advisory boards, sensitization, and linkage to care). The advisory board meetings will be held every month to discuss the progress and receive their feedback. Secondly, orientation and capacity building will be done by onsite coaching to community health workers at the health facility level on BSE. Those trained health workers will frequently capacitate FCHVs during monthly meetings. Then, FCHV will visit the community to be aware of BSE as well as they will be involved in a stigma reduction campaign. Sensitization to FCHVs through orientation and capacity building by providing 3 batch training to selected 3 wards, then FCHVs aware and practice the skills of BSE to the recruited participants during home visit and Thirdly, the suspected and identified cases will be linked by strengthening the referral mechanism of the health system and CHWs reminders for follow-up to cases.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Arm Description: Clusters will be based on the municipality's wards, to measure the effectiveness of implementation outcomes. There are nine wards in the study site, three of which will be selected for intervention group. Thirty samples will be obtained from each randomly selected cluster of intervention. Receives: Behavioral: Implementation strategy - Health Promotion and Education-based intervention |
| Control Arm | No intervention | Arm Description: Thirty samples will be obtained from each randomly selected cluster of control group who would not be given any intervention, this group consist of 90 participants. The usual work done by the health system of Nepal (i.e: PEN package); after the end line, will also capacitate the control group by radio jingle after seven month of intervention. A mass campaign will be conducted on the process and importance of BSE by airing a radio jingle on local FM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE).
Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE). The following indicators will measure this: participants' attitudes toward BSE, perception scores measured in the mean score and SD, and the percentage of women satisfied with BSE practices.
Measured: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Adoption
Adoption will be measured by the percentage of CHW and FCHVs willing to adopt BSE. It will also be measured by the extent to which FCHVs are eager and able to integrate BSE activities into their existing roles and responsibilities.
Measured: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Appropriateness
Appropriateness will be measured using indicators of the extent to which CNMP is suitably suited to the cultural, social, and economic context and aligned with the needs and preferences of the target population.
Measured: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Feasibility of implementing FCHV induced breast-self examination
Feasibility will be measured by assessing the practicality and ease of implementing FCHV in CNMP, quantified through the percentage of health facilities equipped with necessary resources, including training materials and equipment, as well as the proportion of FCHV implementation strategies successfully adopted
Measured: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Fidelity
Fidelity will be measured by evaluating the extent to which FCHVs and HFs adhere to the prescribed guidelines and protocols for BSE screening and referral, monitoring the consistency of FCHV discussed in the HMG meeting across different communities, and evaluating the extent to which women adhere to the prescribed guidelines for BSE.
Measured: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Effectiveness
Effectiveness outcomes will be measured using the following indicators: Perception, attitude, knowledge, coverage of BSE screening, and Follow-up rates for positive cases.
Measured: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start25 Aug 2024
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karnali Academy of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bharat Kafle, Karnali Academy of Health Sciences
- Investigators
- Bharat Kafle, Principal investigator, Karnali Academy of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869759
- Sponsor's protocol ID
- BC2024
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Community Health Workers Induced Prevention of Breast Cancer by Community Health Promotion and Education Implementation Strategies in Jumla - a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06869759
- Acronym / sponsor ID
- BC2024
- Conditions
- Breast Cancer, Prevention
- Keywords
- Health Promotion and Education Strategies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Karnali Academy of Health SciencesUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
Breast cancer is the second most prevalent cancer among Nepali females, accounting for 17.1% of cases and 7.7% of female cancer-related deaths. It is more common in younger, premenopausal women, often diagnosed at advanced stages. Raising awareness through community education is crucial for promoting breast cancer screening, particularly in low-resource settings like Nepal, where clinical breast exams are essential early detection tools. Integrating breast cancer education into the health system can enhance knowledge, encourage screening, and promote healthy behaviors for prevention. Early detection significantly improves treatment outcomes and survival rates.
In remote areas, limited access to advanced detection technologies makes breast self-examination (BSE) the most feasible and cost-effective method, particularly in Jumla. This study evaluates the effectiveness of community health worker-led breast cancer prevention through health promotion and education strategies. It follows PROCTOR's framework and the Health Belief Model (HBM) A mixed-methods design will be employed, incorporating an embedded implementation science approach, a cluster-randomized trial, and mixed-method research. The study population includes married women of Jumla, female community health volunteers (FCHVs), and auxiliary nurse midwives (ANMs). Exclusion criteria include married women ≥20 years old with existing cases of cancer, pregnant or lactating women, FCHVs unable to acquire BSE skills, and untrained ANMs. The sample consists of 90 participants in both intervention and control groups.
Acceptability, Appropriateness, and Feasibility will be assessed using the Acceptability of Intervention Measure (AIM) tool. SOP-based checklists will evaluate fidelity, while FGDs and KIIs will collect qualitative data. Quantitative data will be analyzed using frequency, percentage, mean, and standard deviation. A paired t-test and mixed-effect linear regression will assess effectiveness, while qualitative data will undergo thematic analysis. Findings will be reported per CONSORT guidelines.
Ethical approval will be obtained from the Nepal Health Research Council. Expected outcomes include improved breast cancer knowledge, perception, and screening intention, leading to early detection and reduced prevalence. However, selection bias in cluster trials may limit generalizability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Implementation strategy - Health Promotion and Education-based interventionArm Description: Clusters will be based on the municipality's wards, to measure the effectiveness of implementation outcomes. There are nine wards in the study site, three of which will be selected for intervention group. Thirty samples will be obtained from each randomly selected cluster of intervention. |
| Control Arm | No intervention | –Arm Description: Thirty samples will be obtained from each randomly selected cluster of control group who would not be given any intervention, this group consist of 90 participants. The usual work done by the health system of Nepal (i.e: PEN package); after the end line, will also capacitate the control group by radio jingle after seven month of intervention. A mass campaign will be conducted on the process and importance of BSE by airing a radio jingle on local FM. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Married women >= 20 years of age group women of CNMP Jumla,
- FCHV, those who can read, write, and understand, and
- ANM
Key exclusion criteria (4 listed)
- Married women >= 20 years age group women who had a positive existing case,
- Pregnant and lactating women of CNMP Jumla,
- FCHV those who cannot acquire the minimum skill of breast self-examination,
- ANM who untrained for BSE.
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 |
|---|---|---|
| Implementation strategy - Health Promotion and Education-based interventionFirstly, three broad strategies will be implemented in the intervention arm (use of advisory boards, sensitization, and linkage to care). The advisory board meetings will be held every month to discuss the progress and receive their feedback. Secondly, orientation and capacity building will be done by onsite coaching to community health workers at the health facility level on BSE. Those trained health workers will frequently capacitate FCHVs during monthly meetings. Then, FCHV will visit the community to be aware of BSE as well as they will be involved in a stigma reduction campaign. Sensitization to FCHVs through orientation and capacity building by providing 3 batch training to selected 3 wards, then FCHVs aware and practice the skills of BSE to the recruited participants during home visit and Thirdly, the suspected and identified cases will be linked by strengthening the referral mechanism of the health system and CHWs reminders for follow-up to cases. | Behavioural | Intervention Arm |
Primary outcome
The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE).
Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE). The following indicators will measure this: participants' attitudes toward BSE, perception scores measured in the mean score and SD, and the percentage of women satisfied with BSE practices.
Adoption
Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Adoption will be measured by the percentage of CHW and FCHVs willing to adopt BSE. It will also be measured by the extent to which FCHVs are eager and able to integrate BSE activities into their existing roles and responsibilities.
Appropriateness
Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Appropriateness will be measured using indicators of the extent to which CNMP is suitably suited to the cultural, social, and economic context and aligned with the needs and preferences of the target population.
Feasibility of implementing FCHV induced breast-self examination
Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Feasibility will be measured by assessing the practicality and ease of implementing FCHV in CNMP, quantified through the percentage of health facilities equipped with necessary resources, including training materials and equipment, as well as the proportion of FCHV implementation strategies successfully adopted
Fidelity
Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Fidelity will be measured by evaluating the extent to which FCHVs and HFs adhere to the prescribed guidelines and protocols for BSE screening and referral, monitoring the consistency of FCHV discussed in the HMG meeting across different communities, and evaluating the extent to which women adhere to the prescribed guidelines for BSE.
Effectiveness
Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Effectiveness outcomes will be measured using the following indicators: Perception, attitude, knowledge, coverage of BSE screening, and Follow-up rates for positive cases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Bharat Kafle principal investigator
Karnali Academy of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation strategy - Health Promotion and Education-based intervention in people with Breast Cancer and Prevention, run by Karnali Academy of Health Sciences at 1 site in Nepal.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. 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 Nepal. 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?
This study is still under way. Results are not available in the source record yet.
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?
The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE). (time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention). The study lists 6 primary outcomes in all. 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 11 Mar 2025.