Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
114 participants
INTERVENTIONAL
2025-04-20
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This pre-pilot will inform intervention and procedural refinements for the pilot.
Hypothesis: Participants who receive the intervention (n=57) will report more skin cancer-related preventive behaviors (e.g., mean of summed score of sun protection behaviors such as use of sunscreen, etc.) at three month and six month follow-up compared to those in the control condition (n=57, who will receive general information about physical activity and nutrition).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim 2: Employing a user-centered approach to develop a WhatsApp intervention to promote skin cancer risk-reduction behaviors among Hispanics and encourage engagement in the intervention. Use an iterative qualitative (focus groups with Hispanics, n=32; individual interviews with key stakeholders e.g., health care providers and community leaders, n=10-12) process to incorporate input from Hispanics and relevant stakeholders to develop a mobile WhatsApp intervention that is theory- and culturally-guided.
Aim 3: The investigators will evaluate the feasibility and acceptability of this mobile intervention in a single-arm pre-, post-test pilot study among at-risk Hispanics.
Aim 4: Refine the intervention and conduct a pilot RCT (n = 114) using this mobile program among Hispanics at risk for skin cancer and assess the preliminary effects of the mobile intervention at 3-month (intervention completion) and 6-month follow-ups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Aim 2: We anticipate recruiting four focus groups (2 English, 2 Spanish) with six to eight participants each for a 60-minute audio-recorded focus group. Ten to twelve individual interviews for a 30-60 minute interview via Zoom and recorded.
Aim 3: A single-arm design: participants will receive WhatsApp messages about skin cancer for three months. The participants will need to complete a survey with the same questions in the pre-survey along with the acceptability and feasibility measures at three-month and six-month follow-ups.
Aim 4: A pilot RCT comparing two groups: skin cancer and physical activity and nutrition information. Survey at baseline, three-month and six-month follow-ups.
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mobile skin cancer intervention
Conduct a pilot of the refined intervention among Hispanics to evaluate the preliminary efficacy of the user-centered mobile skin cancer intervention program.
Hispanics Skin Cancer intervention
With the insights from the community, the investigators will then develop the mobile intervention targeting Hispanics at risk for skin cancer to promote sun protection and SSE and get feedback to optimize the intervention. After the random allocation participants will receive instructions on how to use WhatsApp and then the intervention. They will receive WhatsApp messages about skin cancer for three months with optimal frequencies determined by prior aims and complete a post-intervention survey which contains the same questions in the pre-survey. The pilot RCT will be conducted around the spring/summer of Year four of the R00 when UVR is generally the highest in the US. The participants will be contacted at six months after the baseline survey to complete another survey similar to the post-intervention survey.
Control group: physical activity and nutrition information
Participants will complete a baseline survey first; and then they will be randomly assigned into either the intervention group or the control group. After the random allocation participants will receive instructions on how to use WhatsApp and then the intervention. The participants will receive WhatsApp messages about skin cancer for three months with optimal frequencies determined by prior aims and complete a post-intervention survey which contains the same questions in the pre-survey. The participants will be contacted at six months after the baseline survey to complete another survey similar to the post-intervention survey.
Control group: physical activity and nutrition for Hispanics
Content will be developed from established websites such as CDC's Division of Nutrition, Physical Activity and Obesity. We selected these topics because they are also of concern among Hispanics and provide an unrelated attention control.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hispanics Skin Cancer intervention
With the insights from the community, the investigators will then develop the mobile intervention targeting Hispanics at risk for skin cancer to promote sun protection and SSE and get feedback to optimize the intervention. After the random allocation participants will receive instructions on how to use WhatsApp and then the intervention. They will receive WhatsApp messages about skin cancer for three months with optimal frequencies determined by prior aims and complete a post-intervention survey which contains the same questions in the pre-survey. The pilot RCT will be conducted around the spring/summer of Year four of the R00 when UVR is generally the highest in the US. The participants will be contacted at six months after the baseline survey to complete another survey similar to the post-intervention survey.
Control group: physical activity and nutrition for Hispanics
Content will be developed from established websites such as CDC's Division of Nutrition, Physical Activity and Obesity. We selected these topics because they are also of concern among Hispanics and provide an unrelated attention control.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years or older
* No personal history of skin cancer
* Report more than one skin cancer risk factor
* Do not engage in sufficient sun protection behaviors
* Have not conducted a SSE in the past three months
* Own a smartphone and will be willing to use WhatsApp
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rutgers, The State University of New Jersey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhaomeng Niu
Research Associate
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhaomeng Niu, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro2022000533
Identifier Type: OTHER
Identifier Source: secondary_id
132206
Identifier Type: -
Identifier Source: org_study_id