A Mobile Health Intervention Among Hispanics

Cancer of Skin Clinical Trial

Official title:

Developing and Testing a Mobile Health Intervention to Promote Sun Protection Behaviors and Skin Examination Among Hispanics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389332
• Other study ID #: 132206
• Secondary ID: Pro2022000533
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2025
• Est. completion date: April 15, 2026

Study information

• Verified date: January 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Zhaomeng Niu, PhD
• Phone: 509-339-3076
• Email: zhaomeng.niu[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothesis: More than 80% of the participants (n=40) will complete the intervention at three month (intervention completion) and the six month follow-up (retention rate as feasibility). More than 70% of the participants will report high overall study satisfaction (acceptability) with the intervention and study.

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).

Description:

Aim 1: The investigator will conduct individual interviews among key stakeholders such as health care providers and community leaders to plan a mobile skin cancer intervention among Hispanics. Data will be collected from individual interviews (n=10-12) among key stakeholders and triangulated with data from a funded pilot grant (focus groups and surveys with Hispanic community members) to gather information regarding Hispanics perceptions and behaviors related to skin cancer and suggestions for a WhatsApp intervention.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Self-report as Hispanics

• 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:

• Currently being treated for melanoma or nonmelanoma skin cancer

Related Conditions & MeSH terms

• Cancer of Skin
• Skin Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sun protection behavior by self-report	Mean score of use sunscreen with an SPF 30 or higher, seek shade, wear protective clothing, wear wide-brimmed hat, wear sunglasses	The change is being assessed at baseline, three month and six month follow-up intervals
Secondary	Seek shade behavior by self-report	Seek shaded areas	The change is being assessed at baseline, three month and six month follow-up intervals
Secondary	Wear protective clothing behavior by self-report	Wear protective clothing	The change is being assessed at baseline, three month and six month follow-up intervals
Secondary	Wear wide-brimmed hat behavior by self-report	Waer a wide brim hat	The change is being assessed at baseline, three month and six month follow-up intervals
Secondary	Wear sunglasses behavior by self-report	Wear sunglasses	The change is being assessed at baseline, three month and six month follow-up intervals
Secondary	Skin self-examination	Skin examination by oneself	Changes at baseline, three month and six month follow-up intervals
Secondary	Skin examination by a health care professional	skin examination by a health care professional	Changes at baseline, three month and six month follow-up intervals