Breast CancerNCT04397744
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
A study testing Unidas por Vida y Salud prevention program 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 develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently… Read more about this study
- Who is it for?
- Ages 21 to 64 years, women only
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Unidas por Vida y Salud prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2015to 17 Oct 2017
- 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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- overdue for a repeat mammogram
- overdue for repeat cervical screening
Who cannot join
- -
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
The purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- Unidas por Vida y Salud prevention program
- Keywords
- Mammogram, Pap test
- 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.
Unidas por Vida y Salud prevention programBehavioural
The Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers.
| Study group | Role | What they receive |
|---|---|---|
| Unidas por Vida y Salud prevention program | Experimental | Unidas por Vida y Salud (United for Life and Health) prevention program Receives: Behavioral: Unidas por Vida y Salud prevention program |
| No intervention control | No intervention | The control arm will not receive the Unidas por Vida y Salud (United for Life and Health) prevention program during the study analysis period (though, the control arm will receive the intervention after study has been completed). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who uptake clinical breast exam (CBE)
Measured: 6 months
Number of participants who uptake mammography
Measured: 6 months
Number of participants who uptake pap test
Measured: 6 months
Number of participants who repeat mammography
Measured: 6 months
Number of participants who repeat pap test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start16 Jan 2015
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Maria E Fernandez, The University of Texas Health Science Center, Houston
- Investigators
- Maria E Fernandez, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397744
- Sponsor's protocol ID
- HSC-SPH-12-0677
- Status last verified
- May 2020
- First submitted
- 17 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Savas LS, Atkinson JS, Figueroa-Solis E, Valdes A, Morales P, Castle PE, Fernandez ME. A lay health worker intervention to improve breast and cervical cancer screening among Latinas in El Paso, Texas: A randomized control trial. Prev Med. 2021 Apr;145:106446. doi: 10.1016/j.ypmed.2021.106446. Epub 2021 Feb 4.
PubMed 33548363
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
- ClinicalTrials.gov ID
- NCT04397744
- Acronym / sponsor ID
- HSC-SPH-12-0677
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Mammogram, Pap test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 16 Jan 2015 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 21 May 2020 (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 develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unidas por Vida y Salud prevention program | Experimental | Behavioral: Unidas por Vida y Salud prevention programUnidas por Vida y Salud (United for Life and Health) prevention program |
| No intervention control | No intervention | –The control arm will not receive the Unidas por Vida y Salud (United for Life and Health) prevention program during the study analysis period (though, the control arm will receive the intervention after study has been completed). |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- overdue for a repeat mammogram
- overdue for repeat cervical screening
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Unidas por Vida y Salud prevention programThe Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers. | Behavioural | Unidas por Vida y Salud prevention program |
Primary outcome
Number of participants who uptake clinical breast exam (CBE)
Time frame: 6 months
Number of participants who uptake mammography
Time frame: 6 months
Number of participants who uptake pap test
Time frame: 6 months
Number of participants who repeat mammography
Time frame: 6 months
Number of participants who repeat pap test
Time frame: 6 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 21 May 2020.
- Derived from this study: PubMed 33548363Savas LS, Atkinson JS, Figueroa-Solis E, Valdes A, Morales P, Castle PE, Fernandez ME. A lay health worker intervention to improve breast and cervical cancer screening among Latinas in El Paso, Texas: A randomized control trial. Prev Med. 2021 Apr;145:106446. doi: 10.1016/j.ypmed.2021.106446. Epub 2021 Feb 4.
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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.
Maria E Fernandez 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 Unidas por Vida y Salud prevention program 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 2 inclusion and 1 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 21 May 2020. 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 participants who uptake clinical breast exam (CBE) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397744, which also lists 1 linked publication.
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 21 May 2020.