Clinical trial NCT05389332: A Mobile Health Intervention Among Hispanics
Official title: Developing and Testing a Mobile Health Intervention to Promote Sun Protection Behaviors and Skin Examination Among Hispanics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Skin
Keywords: Mobile health
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

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

Primary outcomes:
measure: Sun protection behavior by self-report
timeFrame: The change is being assessed at baseline, three month and six month follow-up intervals
Secondary outcomes:
measure: Seek shade behavior by self-report
timeFrame: The change is being assessed at baseline, three month and six month follow-up intervals
measure: Wear protective clothing behavior by self-report
timeFrame: The change is being assessed at baseline, three month and six month follow-up intervals
measure: Wear wide-brimmed hat behavior by self-report
timeFrame: The change is being assessed at baseline, three month and six month follow-up intervals
measure: Wear sunglasses behavior by self-report
timeFrame: The change is being assessed at baseline, three month and six month follow-up intervals
measure: Skin self-examination
timeFrame: Changes at baseline, three month and six month follow-up intervals
measure: Skin examination by a health care professional
timeFrame: Changes at baseline, three month and six month follow-up intervals
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Zhaomeng Niu, PhD
role: PRINCIPAL_INVESTIGATOR
References: