Sun Protection of Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.

Detailed Description
-----------------
Cognitive interviews about an internet-based sun protection strategies program will be performed with up to 45 kidney transplant recipients (KTRs) who have participated in past surveys. A second group of 150 KTRs will be asked to evaluate the internet-based module for the effectiveness of information. A third group of 12 KTRs will be asked to evaluate the internet-based module for usability. A fourth group of 160 KTRs will be asked to take part in a randomized controlled trial evaluating the fully developed internet-based sun protection strategies program. Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients. (National Kidney Foundation 2006) The NKF supported standard, formal, well timed skin cancer prevention information and sending reminders to KTRs at the beginning of summer. Aims: To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photoprotective pigment in the skin. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.

Official Title
-----------------
Internet-Based Sun Protection Program for Kidney Transplantation Recipients

Conditions
-----------------
Unspecified Complication of Kidney Transplant, Disorder Related to Renal Transplantation

Intervention / Treatment
-----------------
* Behavioral: Internet-based sun protection education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a history of kidney transplantation within the last 5 years Speaks English Can see to read Lives in the greater Chicago area and can attend a cognitive interview session 18-85 years old Exclusion Criteria: Unable to speak English Cognitive impairment or neurologic disease Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level Has had a skin cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sun Protection Education<br>Distribution of the internet-based sun protection educational program. | Behavioral: Internet-based sun protection education<br>* Prior to summer, KTRs who agree to participate will receive a text message with their access code to the Internet intervention to access from their homes on a personal device. After online completion of baseline assessments, participants will be randomized to receive the intervention or general skin care information (control). Following the initial use, the participants may revisit the Internet intervention on a personal device or at the doctor's office on a tablet PC. Over the next 6 weeks, sun protection text reminders will be sent to intervention KTRs' cell phones and they will respond that they read the message. Control participants will receive text messages about general skin care.<br>|
| No Intervention: Control<br>Distribution of general skin care information. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of sun protection | Use of sun protection will be measured using 10 questions about what a person regularly does in summer during a warm sunny day and during a cloudy day regarding: 1) use of sunscreen; 2) wearing hat; 3) shirt with sleeves; 4) sunglasses; and 5) staying in the shade. The scores for these questions will be summed to derive a dichotomous measure of sun protection use (1= use of sun protection often or always; 0 otherwise). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of sun burn or skin irritation from the sun | Three telephone interviews will be done on Mondays after at least 2 holiday weekends in which the weather is reported as sunny or partly sunny by the national weather service (Memorial Day, 4th of July and Labor Day) as well as one sunny non-holiday weekend. The KTR will be asked if they experienced a sunburn or skin irritation. The response will be dichotomous (yes/no). | 6 weeks | 
| Forearm skin pigment | Skin pigment as measured by reflectance spectrophotometry, ranging from limited [225 area-under-the-curve (AUIC)] to dense (75 AUIC). | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant, Renal transplant, Sun protection, Skin cancer