Breast CancerSEMM2NCT06082882
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2
A study testing Education and Navigation to clinic in people with Breast Cancer and Cervical Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Education and Navigation to clinic
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 31 Aug 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 18 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primarily residing in the Gulf Coast \& Lower Rio Grande Valley county areas (or other counties in Texas)
- Women 40 years of age and older with no mammogram in the past 2 years
- Women 21-65 years, with no Pap test in the past 3 years
- Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.
Who cannot join
- Current pregnancy
- Have a current or prior cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Community Based Program to Increase Breast and Cervical Cancer Screening and HPV Vaccination to Reduce the Impact of Breast and Cervical Cancer Among Latinas.
The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.
Read the detailed description
This is an evaluation of the implementation of the Salud en Mis Manos program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination using a one-group pre-post study design (2022-2024). The investigators also describe the implementation of the program during a longer time period (2020-.2024).
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- Education, Navigation to clinic
- Keywords
- Cervical cancer screening, Breast cancer detection, HPV vaccination
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education will be delivered in person in a group education setting or individually by phone. Group education will include a ~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
Navigation to clinicBehavioural
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Community health worker delivered behavioral education and referrals to low-cost services. Delivered in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. Receives: Behavioral: Education; Behavioral: Navigation to clinic |
| Telephone Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. Receives: Behavioral: Education; Behavioral: Navigation to clinic |
| Zoom Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. Receives: Behavioral: Education; Behavioral: Navigation to clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women 40 and older who complete mammogram screening
Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys
Measured: Between baseline and end of study (about 9 months)
Number of women 21-65 years who complete Pap test screening
Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.
Measured: Between baseline and end of study (about 9 months)
Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine
Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.
Measured: Between baseline and end of study (about 9 months)
Secondary outcomes (2)
Number of women 18-26 years who receive dose 2 of HPV vaccine
Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.
Measured: between baseline and end of study (about 9 months)
Number of women 18-26 years who receive dose 3 of HPV vaccine
Among women 18-26 years that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Measured: between baseline and end of study (about 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Feb 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Lara Savas, The University of Texas Health Science Center, Houston
- Investigators
- Lara Savas, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082882
- Sponsor's protocol ID
- HSC-SPH-19-0775
- Other IDs
- PP190061
- Acronym
- SEMM2
- Status last verified
- Dec 2024
- First submitted
- 9 Oct 2023
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Program to Increase Breast and Cervical Cancer Screening and HPV Vaccination to Reduce the Impact of Breast and Cervical Cancer Among Latinas.
- ClinicalTrials.gov ID
- NCT06082882
- Acronym / sponsor ID
- SEMM2 / HSC-SPH-19-0775
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Cervical cancer screening, Breast cancer detection, HPV vaccination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.
Detailed description
This is an evaluation of the implementation of the Salud en Mis Manos program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination using a one-group pre-post study design (2022-2024). The investigators also describe the implementation of the program during a longer time period (2020-.2024).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-Person Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Behavioral: Education, Behavioral: Navigation to clinicCommunity health worker delivered behavioral education and referrals to low-cost services. Delivered in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. |
| Telephone Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Behavioral: Education, Behavioral: Navigation to clinicCommunity health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. |
| Zoom Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Behavioral: Education, Behavioral: Navigation to clinicCommunity health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primarily residing in the Gulf Coast \& Lower Rio Grande Valley county areas (or other counties in Texas)
- Women 40 years of age and older with no mammogram in the past 2 years
- Women 21-65 years, with no Pap test in the past 3 years
- Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.
Key exclusion criteria (2 listed)
- Current pregnancy
- Have a current or prior cancer diagnosis
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 |
|---|---|---|
| EducationEducation will be delivered in person in a group education setting or individually by phone. Group education will include a ~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed). | Behavioural | In-Person Delivered Breast and Cervical Cancer Behavioral Intervention, Telephone Delivered Breast and Cervical Cancer Behavioral Intervention, Zoom Delivered Breast and Cervical Cancer Behavioral Intervention |
| Navigation to clinicContinue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services. | Behavioural | In-Person Delivered Breast and Cervical Cancer Behavioral Intervention, Telephone Delivered Breast and Cervical Cancer Behavioral Intervention, Zoom Delivered Breast and Cervical Cancer Behavioral Intervention |
Primary outcome
Number of women 40 and older who complete mammogram screening
Time frame: Between baseline and end of study (about 9 months)
Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys
Number of women 21-65 years who complete Pap test screening
Time frame: Between baseline and end of study (about 9 months)
Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.
Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine
Time frame: Between baseline and end of study (about 9 months)
Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.
2 secondary outcomes
Number of women 18-26 years who receive dose 2 of HPV vaccine
Time frame: between baseline and end of study (about 9 months)
Number of women 18-26 years who receive dose 3 of HPV vaccine
Time frame: between baseline and end of study (about 9 months)
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 12 Dec 2024.
- 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.
Lara Savas, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Navigation to clinic in people with Breast Cancer and Cervical Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 4 inclusion and 2 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 12 Dec 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 United States. 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?
Number of women 40 and older who complete mammogram screening (time frame: Between baseline and end of study (about 9 months)). The study lists 3 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 12 Dec 2024.