A Mobile Health Intervention Among Hispanics

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389332
Collaborator
(none)
210
1
4
58
3.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile-based and user-centered intervention
  • Behavioral: Baseline survey and post-intervention survey.
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Developing and Testing a Mobile Health Intervention to Promote Sun Protection Behaviors and Skin Examination Among Hispanics
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interviews and focus groups

This arm will employ a user-centered approach to conduct interviews/focus groups among Hispanics to explore factors associated with their sun protection and SSE such as barriers and knowledge. The interviews/focus groups will help to identify additional relevant factors associated with both sun protection and SSE among Hispanics.

Behavioral: Mobile-based and user-centered 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.

Experimental: Testing

Conduct formative testing of the intervention and collect feasibility and acceptability data, and qualitative feedback on improving the intervention.

Behavioral: Mobile-based and user-centered 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.

Experimental: 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.

Behavioral: Mobile-based and user-centered 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.

Active Comparator: 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.

Behavioral: Baseline survey and post-intervention survey.
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.

Outcome Measures

Primary Outcome Measures

  1. Sun protection behavior by self-report [The change is being assessed at baseline, three month and six month follow-up intervals]

    Mean score of use sunscreen with an SPF 30 or higher, seek shade, wear protective clothing, wear wide-brimmed hat, wear sunglasses

Secondary Outcome Measures

  1. Seek shade behavior by self-report [The change is being assessed at baseline, three month and six month follow-up intervals]

    Seek shaded areas

  2. Wear protective clothing behavior by self-report [The change is being assessed at baseline, three month and six month follow-up intervals]

    Wear protective clothing

  3. Wear wide-brimmed hat behavior by self-report [The change is being assessed at baseline, three month and six month follow-up intervals]

    Waer a wide brim hat

  4. Wear sunglasses behavior by self-report [The change is being assessed at baseline, three month and six month follow-up intervals]

    Wear sunglasses

  5. Skin self-examination [Changes at baseline, three month and six month follow-up intervals]

    Skin examination by oneself

  6. Skin examination by a health care professional [Changes at baseline, three month and six month follow-up intervals]

    skin examination by a health care professional

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Zhaomeng Niu, PhD, Rutgers Cancer Institute of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhaomeng Niu, Research Associate, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT05389332
Other Study ID Numbers:
  • CINJ132206
First Posted:
May 25, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhaomeng Niu, Research Associate, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022