Sun Protection of Kidney Transplant Recipients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University
ClinicalTrials.gov Identifier:
NCT01646099
First received: July 13, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Unspecified Complication of Kidney Transplant
Disorder Related to Renal Transplantation
Behavioral: Internet-based sun protection education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Internet-Based Sun Protection Program for Kidney Transplantation Recipients

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 367
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646099

Contacts
Contact: Francisco Acosta, MS 312-926-7426 francisco.acosta@northwestern.edu
Contact: Yanina Guevara, BA 312-926-7428 yanina.guevara@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Faculty Foundation Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Francisco Acosta, MS    312-926-7426    francisco.acosta@northwestern.edu   
Contact: Yanina Guevara    312-694-7787    yanina.guevara@northwestern.edu   
Principal Investigator: June K. Robinson, M.D.         
Sub-Investigator: Elisa J. Gordon, Ph.D., MPH         
Sub-Investigator: Marla L. Clayman, Ph.D.         
Sub-Investigator: Jenna Duffecy, PhD         
Sub-Investigator: John J. Friedewald, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: June K. Robinson, M.D. Northwestern University
  More Information

No publications provided

Responsible Party: June Robinson, Research Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01646099     History of Changes
Other Study ID Numbers: STU00058220
Study First Received: July 13, 2012
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Kidney transplant
Renal transplant
Sun protection
Skin cancer

ClinicalTrials.gov processed this record on July 23, 2014