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Sun Protection of Kidney Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University
ClinicalTrials.gov Identifier:
NCT01646099
First received: July 13, 2012
Last updated: July 30, 2014
Last verified: July 2014

July 13, 2012
July 30, 2014
November 2013
October 2014   (final data collection date for primary outcome measure)
Use of sun protection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01646099 on ClinicalTrials.gov Archive Site
  • Level of sun burn or skin irritation from the sun [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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: 1 year ] [ Designated as safety issue: No ]
    Skin pigment as measured by reflectance spectrophotometry, ranging from limited [225 area-under-the-curve (AUIC)] to dense (75 AUIC).
Same as current
Not Provided
Not Provided
 
Sun Protection of Kidney Transplant Recipients
Internet-Based Sun Protection Program for Kidney Transplantation Recipients

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.

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:

  1. 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.
  2. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
  3. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Unspecified Complication of Kidney Transplant
  • Disorder Related to Renal Transplantation
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.
  • Experimental: Sun Protection Education
    Distribution of the internet-based sun protection educational program.
    Intervention: Behavioral: Internet-based sun protection education
  • No Intervention: Control
    Distribution of general skin care information.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
367
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Francisco Acosta, MS 312-926-7426 francisco.acosta@northwestern.edu
Contact: Yanina Guevara, BA 312-926-7428 yanina.guevara@northwestern.edu
United States
 
NCT01646099
STU00058220
No
June Robinson, Northwestern University
Northwestern University
Not Provided
Principal Investigator: June K. Robinson, M.D. Northwestern University
Northwestern University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP