Randomized Controlled Trial of the MySmartSkin to Promote Sun Protection

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Introduction

There are approximately 90,000 cases of malignant melanoma that require diagnosis, making it the fifth most diagnosed cancer, with incidents typically increasing over time.

Purpose

The goal of this research is to conduct a randomized controlled trial to a new intervention (MySmartSkin) to determine skincare behavior amongst cancer patients

Project Overview

We conducted this project into 2 phases:

  • Phase 1 focuses on the development the MySmartSkin intervention
  • Phase 2 focuses on a randomized controlled trial of the MySmartSkin

Phase 1

The MySmartSkin intervention underwent development and refinement, incorporating a web-based online survey where participants provide information about their cancer status.

Phase 2

The goal is to assess the outcomes of MySmartSkin compared to the standard care for skin cancer patients. Patients were selected based on specific characteristics and assigned to randomized groups for the study.

Process Summary

Patients are chosen based on their stage of skin-cancer and are randomized to either the treatment or control groups

Flowchart of alignment and allocation

Stages of Melanoma

Treatment group gets the MySmartSkin whereas control group gets the usual-care treatment on their skin cancer. Results were measured through surveys every 8 weeks, 24 weeks, and 48 weeks later.

The statistical methods employed in this trial include Randomized Controlled trial, T-tests, and Chi-Squared tests aimed at examining differences in demographic and clinical characteristics among individuals.

Results

  • Total (N = 287 )
  • mySmartSkin intervention (n = 139 )
  • Usual care (n = 148 )
Body AreaExamined (%)Examined (n)Examined (%)Examined (n)Examined (%)Examined (n)
Scalp37.910839.65536.353
Face98.328299.313897.3144
Neck89.825690.712689.0130
Shoulders88.225387.812288.5131
Front of arms97.928098.613797.3143
Back of arms79.822978.410981.1120
Chest93.726894.213093.2138
Stomach87.725087.712187.8129
Upper back54.915755.17654.781
Lower back48.813950.06947.670
Front of legs94.026693.412894.5138
Back of legs72.620471.39773.8107
Bottom of feet41.611940.65642.663
Buttocks40.411639.65541.261
Genitals44.412742.05846.669

Of the 441 patients that consented to the trial

  • N1=224 were placed into the treatment group, assigned MySmartSkin
  • N2=217 patients were placed in the control group which is basically standard treatment

From the results of the intervention (MySmartSkin), we see that certain body parts showed a reduction in tumor size; however, the difference is not too significant

Conclusion

While there is some reduction in skin tumor size for the treatment group, the observed difference is not too significant; further research is needed on MySmartSkin to comprehensively test and evaluate its effectiveness.