Breast CancerNCT04426019
Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women
A study testing CLS Intervention and No CLS intervention 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 primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- CLS Intervention and No CLS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,025 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2012to 16 May 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women who identify as Hispanic/Latina ancestry or descent and live in the Greater Houston Area in Texas
- no previous diagnosis of breast or cervical cancer
Who cannot join
- Pregnant women, and women who are adherent to screening guidelines
- prior or current 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: Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston
The primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. The adaptation and delivery of the CLS intervention program focuses on meeting the needs and supporting of CHWs and Hispanic/Latina women in the Greater Houston Area. Finally, this study aims to evaluate the process and effect of the adapted CLS program (renamed Salud en Mis Manos (SEMM) on increasing mammography and cervical cancer screening.
Read the detailed description
CHWs identify women in the community in need of breast and/or cervical cancer screening. Based on their screening needs, they invite women to participate in the CLS behavioral intervention. Women are randomized to intervention and usual care comparison (delayed intervention) groups. After women are consented to participate in the study, the study team administers the baseline survey. After the baseline survey is administered, the CLS-adapted intervention (renamed Salud en Mis Manos), is delivered to participants randomized to the intervention group. After the follow-up survey is administered to the participants, women in the comparison group are offered the CLS (SEMM) intervention.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- CLS Intervention, No CLS intervention
- 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.
CLS InterventionBehavioural
Also called CHW-delivered education
Community health workers (or promotoras) will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening
No CLS interventionBehavioural
Also called Usual Care
This control arm will receive only usual practice care (print education) and will not receive the CLS intervention. They may receive the intervention after the study has been completed
| Study group | Role | What they receive |
|---|---|---|
| CLS intervention | Experimental | Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver behavioral education designed to increase breast and/or cervical cancer screening. After completing the education, CHWs provide women with clinic referrals to local and affordable screening services. Participants also are offered telephone-delivered navigation support, which focuses on helping women overcome logistic and personal barriers to accessing screening services. Receives: Behavioral: CLS Intervention |
| No CLS intervention | Active comparator | Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines. Receives: Behavioral: No CLS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report.
Outcomes based on self-report on follow-up survey
Measured: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
The primary outcome for cervical cancer screening outcome based on Pap screening behavior measured among participants using self-report.
Outcomes based on self-report on follow-up survey
Measured: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start12 Jan 2012
- Primary completion16 May 2014
- Study completion16 May 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,025 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, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426019
- Sponsor's protocol ID
- HSC-SPH-11-0179
- Status last verified
- Oct 2023
- First submitted
- 27 May 2020
- Last updated
- 12 Oct 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston
- ClinicalTrials.gov ID
- NCT04426019
- Acronym / sponsor ID
- HSC-SPH-11-0179
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Mammogram, Pap test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 12 Jan 2012 (actual)
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 16 May 2014 (actual)
- First posted
- 11 Jun 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 primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. The adaptation and delivery of the CLS intervention program focuses on meeting the needs and supporting of CHWs and Hispanic/Latina women in the Greater Houston Area. Finally, this study aims to evaluate the process and effect of the adapted CLS program (renamed Salud en Mis Manos (SEMM) on increasing mammography and cervical cancer screening.
Detailed description
CHWs identify women in the community in need of breast and/or cervical cancer screening. Based on their screening needs, they invite women to participate in the CLS behavioral intervention. Women are randomized to intervention and usual care comparison (delayed intervention) groups. After women are consented to participate in the study, the study team administers the baseline survey. After the baseline survey is administered, the CLS-adapted intervention (renamed Salud en Mis Manos), is delivered to participants randomized to the intervention group. After the follow-up survey is administered to the participants, women in the comparison group are offered the CLS (SEMM) intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLS intervention | Experimental | Behavioral: CLS InterventionCommunity health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver behavioral education designed to increase breast and/or cervical cancer screening. After completing the education, CHWs provide women with clinic referrals to local and affordable screening services. Participants also are offered telephone-delivered navigation support, which focuses on helping women overcome logistic and personal barriers to accessing screening services. |
| No CLS intervention | Active comparator | Behavioral: No CLS interventionCommunity health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women who identify as Hispanic/Latina ancestry or descent and live in the Greater Houston Area in Texas
- no previous diagnosis of breast or cervical cancer
Key exclusion criteria (2 listed)
- Pregnant women, and women who are adherent to screening guidelines
- prior or current 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 |
|---|---|---|
| CLS InterventionAlso: CHW-delivered educationCommunity health workers (or promotoras) will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening | Behavioural | CLS intervention |
| No CLS interventionAlso: Usual CareThis control arm will receive only usual practice care (print education) and will not receive the CLS intervention. They may receive the intervention after the study has been completed | Behavioural | No CLS intervention |
Primary outcome
The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report.
Time frame: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
Outcomes based on self-report on follow-up survey
The primary outcome for cervical cancer screening outcome based on Pap screening behavior measured among participants using self-report.
Time frame: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
Outcomes based on self-report on follow-up survey
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 12 Oct 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 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 CLS Intervention and No CLS intervention 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 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 12 Oct 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?
The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report. (time frame: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).). The study lists 2 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 Oct 2023.