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ProSalud in Latinos Living in Rural/Agricultural Communities Within Moffitt's Catchment Area

NCT ID: NCT07218848

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-22

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ProSalud

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.

Group Type EXPERIMENTAL

Aim 1 Workshops

Intervention Type OTHER

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 Groups

Intervention Type OTHER

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.

Interventions

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Aim 1 Workshops

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.

Intervention Type OTHER

Aim 2 Focus Groups

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.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Kanetsky, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Marilyn Stern, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marilyn Stern, PhD

Role: CONTACT

Phone: 813-974-0966

Email: [email protected]

Other Identifiers

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MCC-23665

Identifier Type: -

Identifier Source: org_study_id