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Recruiting NCT05389332

A Mobile Health Intervention Among Hispanics

No phase Interventional Cancer of Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hispanics Skin Cancer intervention, Control group: physical activity and nutrition for Hispanics.
Who it may be relevant to
Registry conditions: Cancer of Skin. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Detailed 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.

Interventions

  • 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
  • Behavioral 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.

Primary outcome measures

  • Sun protection behavior by self-report [Time frame: The change is being assessed at baseline, three month and six month follow-up intervals]
Secondary outcome measures (6)
  • Seek shade behavior by self-report [Time frame: The change is being assessed at baseline, three month and six month follow-up intervals]
  • Wear protective clothing behavior by self-report [Time frame: The change is being assessed at baseline, three month and six month follow-up intervals]
  • Wear wide-brimmed hat behavior by self-report [Time frame: The change is being assessed at baseline, three month and six month follow-up intervals]
  • Wear sunglasses behavior by self-report [Time frame: The change is being assessed at baseline, three month and six month follow-up intervals]
  • Skin self-examination [Time frame: Changes at baseline, three month and six month follow-up intervals]
  • Skin examination by a health care professional [Time frame: Changes at baseline, three month and six month follow-up intervals]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Rutgers Cancer Institute of New Jersey — New Brunswick

Identifiers

NCT: NCT05389332 · 132206 · Pro2022000533

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗