Cervical CancerSEMM1NCT06082505
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1
A study testing Education and Navigation to clinic in people with Cervical Cancer and Breast Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose is to evaluate implementation of a community-based prevention project aimed at increasing 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 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Breast Cancer
- What is being tested?
- Education and Navigation to clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,262 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 29 May 2019
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self identifies as Hispanic or Latina
- Lives in Texas
- Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older
- Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older
- HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series
- Age limit for breast cancer screening group: 40 years and older
- Age limit for cervical cancer screening group (Pap test): 21 years and older
- Age limit for HPV vaccination group: 21-26 years
Who cannot join
- Current pregnancy
- 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 is to evaluate implementation of a community-based prevention project aimed at increasing 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 Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion 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 (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).
- Conditions
- Cervical Cancer, Breast Cancer
- Being tested
- Education, Navigation to clinic
- Keywords
- Cervical cancer prevention, Breast cancer detection, HPV vaccination
- Medical subject headings
- Uterine Cervical Neoplasms, Breast 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 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed scheduled session twice (education materials would be printed and mailed).
Navigation to clinicBehavioural
Continue telephone based navigation tailored to participants' barriers using the 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 deliver behavioral education and referrals to low-cost services. Deliver 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 deliver behavioral education and referrals to low-cost services. 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 years and older who complete mammogram screening
Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Measured: Between baseline and end of study (about 9 months)
Number of women 21-65 years old who complete Pap test screening
Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.
Measured: Between baseline and end of study (about 9 months)
Number of women 21-26 years old who initiate their HPV vaccination series.
Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.
Measured: between baseline and end of study (about 9 months)
Secondary outcomes (3)
Number of participants who received the second dose of HPV vaccine
Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Measured: between baseline and end of study (about 9 months)
Number of participants who received the third dose of HPV vaccine
Among women 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)
Number of participants who received a clinical breast exam
Among women that have not had a mammogram in the past two years, 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 start1 Nov 2016
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,262 participants (actual)
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
- NCT06082505
- Sponsor's protocol ID
- HSC-SPH-16-0159
- Other IDs
- PP160047
- Acronym
- SEMM1
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 1 Dec 2023
- 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 1 Dec 2023. 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
- NCT06082505
- Acronym / sponsor ID
- SEMM1 / HSC-SPH-16-0159
- Conditions
- Cervical Cancer, Breast Cancer
- Keywords
- Cervical cancer prevention, Breast cancer detection, HPV vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,262 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- 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 is to evaluate implementation of a community-based prevention project aimed at increasing 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 Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion 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 (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Delivered Breast and Cervical Cancer Behavioral Intervention | Experimental | Behavioral: Education, Behavioral: Navigation to clinicCommunity health worker deliver behavioral education and referrals to low-cost services. Deliver 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 deliver behavioral education and referrals to low-cost services. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self identifies as Hispanic or Latina
- Lives in Texas
- Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older
- Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older
- HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series
Key exclusion criteria (2 listed)
- Current pregnancy
- 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 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed 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 |
| Navigation to clinicContinue telephone based navigation tailored to participants' barriers using the 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 |
Primary outcome
Number of women 40 years and older who complete mammogram screening
Time frame: Between baseline and end of study (about 9 months)
Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Number of women 21-65 years old who complete Pap test screening
Time frame: Between baseline and end of study (about 9 months)
Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.
Number of women 21-26 years old who initiate their HPV vaccination series.
Time frame: between baseline and end of study (about 9 months)
Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.
3 secondary outcomes
Number of participants who received the second dose of HPV vaccine
Time frame: between baseline and end of study (about 9 months)
Number of participants who received the third dose of HPV vaccine
Time frame: between baseline and end of study (about 9 months)
Number of participants who received a clinical breast exam
Time frame: between baseline and end of study (about 9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- 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 Cervical Cancer and Breast 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 8 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: finished, as of the sponsor's last update on 1 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 years 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 1 Dec 2023.