Sun Protection of Kidney Transplant Recipients
|ClinicalTrials.gov Identifier: NCT01646099|
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : April 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Complication of Kidney Transplant Disorder Related to Renal Transplantation||Behavioral: Internet-based sun protection education||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||335 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Internet-Based Sun Protection Program for Kidney Transplantation Recipients|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Sun Protection Education
Distribution of the internet-based sun protection educational program.
Behavioral: Internet-based sun protection education
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.
No Intervention: Control
Distribution of general skin care information.
- Use of sun protection [ Time Frame: 6 weeks ]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).
- Level of sun burn or skin irritation from the sun [ Time Frame: 6 weeks ]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).
- Forearm skin pigment [ Time Frame: 6 weeks ]Skin pigment as measured by reflectance spectrophotometry, ranging from limited [225 area-under-the-curve (AUIC)] to dense (75 AUIC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646099
|United States, Illinois|
|Northwestern Memorial Faculty Foundation|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||June K. Robinson, M.D.||Northwestern University|