A Mobile Health Intervention Among Hispanics

NCT05389332 | Recruiting

• 2 other identifiers: 132206Pro2022000533
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer of Skin

Keywords

Mobile health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Seek shade behavior by self-report

  The change is being assessed at baseline, three month and six month follow-up intervals

• Wear protective clothing behavior by self-report

  The change is being assessed at baseline, three month and six month follow-up intervals

• Wear wide-brimmed hat behavior by self-report

  The change is being assessed at baseline, three month and six month follow-up intervals

• Wear sunglasses behavior by self-report

  The change is being assessed at baseline, three month and six month follow-up intervals

• Skin self-examination

  Changes at baseline, three month and six month follow-up intervals

Study Arms (2)

Mobile skin cancer intervention

EXPERIMENTAL

Conduct a pilot of the refined intervention among Hispanics to evaluate the preliminary efficacy of the user-centered mobile skin cancer intervention program.

Behavioral: Hispanics Skin Cancer intervention

Control group: physical activity and nutrition information

ACTIVE COMPARATOR

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.

Behavioral: Control group: physical activity and nutrition for Hispanics

Interventions

Hispanics Skin Cancer intervention BEHAVIORAL

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.

Mobile skin cancer intervention

Control group: physical activity and nutrition for Hispanics BEHAVIORAL

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.

Control group: physical activity and nutrition information

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report as Hispanics
• 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

You may not qualify if:

• Currently being treated for melanoma or nonmelanoma skin cancer

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Zhaomeng Niu, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaomeng Niu, PhD

CONTACT

509-339-3076; zhaomeng.niu@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Aim 1: Interviews with ten to twelve health care providers and community leaders for a 30-60 minute interview via Zoom and recorded. 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.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 25, 2022
• Study Start: April 20, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)