CancerNCT07218848
ProSalud in Latinos Living in Rural/Agricultural Communities Within Moffitt's Catchment Area
A study testing Aim 1 Workshops and Aim 2 Focus Groups in people with Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of the study is to find out if Latino families living in rural parts of Florida are interested in learning about cancer prevention through our ProSalud program and whether it helps them make healthier choices to lower their risk of cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Aim 1 Workshops and Aim 2 Focus Groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2025to 26 Oct 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We will include adults of any age and sex who are parents of a 6- to 12-year-old child. Parents must speak Spanish and be able to read and write at the 4th-grade level. Parents who speak English in addition to Spanish can also take part in the study, always considering that the workshop will be conducted in Spanish.
- Individuals who are wards of the state will be excluded from participation in this study.
- If a participant chooses not to take part at any point, they may do so without any consequences or loss of services provided through RCMA. This ensures that their rights are protected, and their decision will not affect their access to any services or support.
- We may, by chance, include students and employees. However, we do not plan on collecting information that would indicate any of these statuses. No wards will be included in the study. Wards will not be included as research participants. Because recruitment will happen through RCMA, we anticipate most participants to be socially and/or economically disadvantaged. Participation in this study is entirely voluntary.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Moffitt Cancer Center
Tampa, Florida, 33612
University of South Florida
Tampa, Florida, 33612
About this study
Official title: ProSalud: A Health Promotion Project to Reduce Cancer Risk in Latinos Living in Rural/Agricultural Communities Within Moffitt's Catchment Area
The purpose of the study is to find out if Latino families living in rural parts of Florida are interested in learning about cancer prevention through our ProSalud program and whether it helps them make healthier choices to lower their risk of cancer. The study will also gather people's opinions about the program to find ways to improve it in the future. For the first part of our study, Latino parents with children between the ages of 6 and 12 will be invited to take part in a one-hour (or one-and-a-half-hour) workshop. The workshop will teach about healthy habits like eating well, being active, and protecting skin from the sun. For the second part of the study, some parents who participated in the workshops will be randomly chosen to join a focus group. In the focus group, they'll be asked questions to help us make the workshop better and make sure it fits the culture, needs, and preferences of Latino families in rural communities.
- Conditions
- Cancer
- Being tested
- Aim 1 Workshops, Aim 2 Focus Groups
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 1 WorkshopsOther
Eligible Latino parents of 6 to 12-years-old will participate in a one hour (hour and a half) workshop focused on increasing rural Latino community members' knowledge about modifiable behaviors, such as healthy eating, physical activity, and sun protection. Participants will complete a baseline assessment a week before the workshop and a 2-month follow-up assessment. The assessments will be administered by research staff in person or over Zoom/telephone and will assess the acceptability and feasibility of the workshop and key modifiable health behaviors associated with cancer risk reduction.
Aim 2 Focus GroupsOther
Parents for Aim 2 focus groups will be randomly selected from each of the Aim 1 cohorts from those completing all Aim 1 components. Participating parents in the focus groups will be asked semi-structured questions derived from Aim 1 quantitative findings. These questions will further assess the content presented in ProSalud to refine and optimize our culturally tailored health promotion and cancer prevention workshop to best meet the needs and preferences of Latino community members.
| Study group | Role | What they receive |
|---|---|---|
| ProSalud | Experimental | Aim 1: Quantitatively assess feasibility and acceptability of ProSalud and explore changes in cancer risk reduction behaviors.
Aim 2: Qualitatively examine ways to optimize ProSalud. After Aim 1 follow-up is completed, we will recruit a subgroup of parent participants and conduct focus groups to further assess ProSalud with the goal of refining and optimizing our culturally tailored health promotion and cancer prevention workshop to best meet needs and preferences of Latino community members. Semi-structured focus group questions will derive from our quantitative findings in Aim 1. Receives: Other: Aim 1 Workshops; Other: Aim 2 Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability will be confirmed if ≥80% of enrolled participants indicate an intention to implement behavioral recommendations.
Measured: 1 year
Demand feasibility and adherence
The study will be considered feasible if ≥75% of eligible parents approached to participate in the study agree to enroll.
Measured: 1 year
Implementation feasibility
Implementation feasibility will be established if 100% of data collection is completed in the 1-year timeframe.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start22 May 2025
- Primary completion26 Oct 2026
- Study completion26 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kanetsky, MPH, PhD, Principal investigator, Moffitt Cancer CenterMarilyn Stern, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218848
- Sponsor's protocol ID
- MCC-23665
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProSalud: A Health Promotion Project to Reduce Cancer Risk in Latinos Living in Rural/Agricultural Communities Within Moffitt's Catchment Area
- ClinicalTrials.gov ID
- NCT07218848
- Acronym / sponsor ID
- MCC-23665
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 26 Oct 2026 (actual)
- Study completion
- 26 Oct 2026 (actual)
- First posted
- 20 Oct 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.
The purpose of the study is to find out if Latino families living in rural parts of Florida are interested in learning about cancer prevention through our ProSalud program and whether it helps them make healthier choices to lower their risk of cancer. The study will also gather people's opinions about the program to find ways to improve it in the future. For the first part of our study, Latino parents with children between the ages of 6 and 12 will be invited to take part in a one-hour (or one-and-a-half-hour) workshop. The workshop will teach about healthy habits like eating well, being active, and protecting skin from the sun. For the second part of the study, some parents who participated in the workshops will be randomly chosen to join a focus group. In the focus group, they'll be asked questions to help us make the workshop better and make sure it fits the culture, needs, and preferences of Latino families in rural communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProSalud | Experimental | Other: Aim 1 Workshops, Other: Aim 2 Focus GroupsAim 1: Quantitatively assess feasibility and acceptability of ProSalud and explore changes in cancer risk reduction behaviors. Aim 2: Qualitatively examine ways to optimize ProSalud. After Aim 1 follow-up is completed, we will recruit a subgroup of parent participants and conduct focus groups to further assess ProSalud with the goal of refining and optimizing our culturally tailored health promotion and cancer prevention workshop to best meet needs and preferences of Latino community members. Semi-structured focus group questions will derive from our quantitative findings in Aim 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- We will include adults of any age and sex who are parents of a 6- to 12-year-old child. Parents must speak Spanish and be able to read and write at the 4th-grade level. Parents who speak English in addition to Spanish can also take part in the study, always considering that the workshop will be conducted in Spanish.
- Individuals who are wards of the state will be excluded from participation in this study.
- If a participant chooses not to take part at any point, they may do so without any consequences or loss of services provided through RCMA. This ensures that their rights are protected, and their decision will not affect their access to any services or support.
- We may, by chance, include students and employees. However, we do not plan on collecting information that would indicate any of these statuses. No wards will be included in the study. Wards will not be included as research participants. Because recruitment will happen through RCMA, we anticipate most participants to be socially and/or economically disadvantaged. Participation in this study is entirely voluntary.
Key exclusion criteria (0 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 |
|---|---|---|
| Aim 1 WorkshopsEligible Latino parents of 6 to 12-years-old will participate in a one hour (hour and a half) workshop focused on increasing rural Latino community members' knowledge about modifiable behaviors, such as healthy eating, physical activity, and sun protection. Participants will complete a baseline assessment a week before the workshop and a 2-month follow-up assessment. The assessments will be administered by research staff in person or over Zoom/telephone and will assess the acceptability and feasibility of the workshop and key modifiable health behaviors associated with cancer risk reduction. | Other | ProSalud |
| Aim 2 Focus GroupsParents for Aim 2 focus groups will be randomly selected from each of the Aim 1 cohorts from those completing all Aim 1 components. Participating parents in the focus groups will be asked semi-structured questions derived from Aim 1 quantitative findings. These questions will further assess the content presented in ProSalud to refine and optimize our culturally tailored health promotion and cancer prevention workshop to best meet the needs and preferences of Latino community members. | Other | ProSalud |
Primary outcome
Acceptability
Time frame: 1 year
Acceptability will be confirmed if ≥80% of enrolled participants indicate an intention to implement behavioral recommendations.
Demand feasibility and adherence
Time frame: 1 year
The study will be considered feasible if ≥75% of eligible parents approached to participate in the study agree to enroll.
Implementation feasibility
Time frame: 1 year
Implementation feasibility will be established if 100% of data collection is completed in the 1-year timeframe.
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 29 Oct 2026.
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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.
Peter Kanetsky, MPH, PhD principal investigator
Moffitt Cancer Center
Marilyn Stern, PhD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aim 1 Workshops and Aim 2 Focus Groups in people with Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 0 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Acceptability (time frame: 1 year). 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 29 Oct 2026.