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A Mobile Health Intervention Among Hispanics

Primary Purpose

Cancer of Skin

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hispanics Skin Cancer intervention
Control group: physical activity and nutrition for Hispanics
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer of Skin focused on measuring Mobile health

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New JerseyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile skin cancer intervention

Control group: physical activity and nutrition information

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Seek shade behavior by self-report
Seek shaded areas
Wear protective clothing behavior by self-report
Wear protective clothing
Wear wide-brimmed hat behavior by self-report
Waer a wide brim hat
Wear sunglasses behavior by self-report
Wear sunglasses
Skin self-examination
Skin examination by oneself
Skin examination by a health care professional
skin examination by a health care professional

Full Information

First Posted
May 17, 2022
Last Updated
July 6, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05389332
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
April 15, 2026 (Anticipated)
Study Completion Date
April 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Skin
Keywords
Mobile health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile skin cancer intervention
Arm Type
Experimental
Arm Description
Conduct a pilot of the refined intervention among Hispanics to evaluate the preliminary efficacy of the user-centered mobile skin cancer intervention program.
Arm Title
Control group: physical activity and nutrition information
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hispanics Skin Cancer intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group: physical activity and nutrition for Hispanics
Intervention Description
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 Measure Information:
Title
Sun protection behavior by self-report
Description
Mean score of use sunscreen with an SPF 30 or higher, seek shade, wear protective clothing, wear wide-brimmed hat, wear sunglasses
Time Frame
The change is being assessed at baseline, three month and six month follow-up intervals
Secondary Outcome Measure Information:
Title
Seek shade behavior by self-report
Description
Seek shaded areas
Time Frame
The change is being assessed at baseline, three month and six month follow-up intervals
Title
Wear protective clothing behavior by self-report
Description
Wear protective clothing
Time Frame
The change is being assessed at baseline, three month and six month follow-up intervals
Title
Wear wide-brimmed hat behavior by self-report
Description
Waer a wide brim hat
Time Frame
The change is being assessed at baseline, three month and six month follow-up intervals
Title
Wear sunglasses behavior by self-report
Description
Wear sunglasses
Time Frame
The change is being assessed at baseline, three month and six month follow-up intervals
Title
Skin self-examination
Description
Skin examination by oneself
Time Frame
Changes at baseline, three month and six month follow-up intervals
Title
Skin examination by a health care professional
Description
skin examination by a health care professional
Time Frame
Changes at baseline, three month and six month follow-up intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaomeng Niu, PhD
Phone
509-339-3076
Email
zhaomeng.niu@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaomeng Niu, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaomeng Niu, PhD
Phone
732-235-7921
Email
zhaomeng.niu@rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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A Mobile Health Intervention Among Hispanics

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