Evaluation of Sun Protection Education for Kidney Transplant Recipients

July 30, 2014 updated by: June Robinson, Northwestern University
This study is being done to evaluate the effectiveness of a Sun Protection Strategies workbook for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at an increased risk of developing skin cancer. The program will help people learn about how to practice effective sun protection after the transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cognitive interview about the Sun Protection Strategies workbook will be performed with up to 25 kidney transplant recipients (KTR) who have participated in past surveys. A second phase of the study involves 156 KTRs that will be asked to take part in a randomized controlled trial evaluating the fully developed sun protective strategies workbook.

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).

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 photo-protective pigment in the skin.
  2. To pilot test the sun protection workbook with English speaking KTRs representing the 3 ethnic groups: White, Black and Hispanic.
  3. To assess the effectiveness of an education intervention encouraging the use of sun protection strategies.
  4. To explore understanding of the importance of sun protection and the KTRs confidence in their being able to practice sun protection.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Faculty Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a history of kidney transplantation within the last 2-24 months
  • Speaks English
  • Can see to read
  • Lives in the greater Chicago area and can attend two study visits
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Workbook
Distribution of the sun protection educational workbook
Behavioral: Workbook
Subjects will read a workbook about sun protection
No Intervention: Control
Distribution of general skin care information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
use of sun protection
Time Frame: An average of 1 year
Subjects will complete self-report surveys of behavior prior to educational intervention and 6- 8 weeks after the educational intervention
An average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: June K. Robinson, M.D., Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00069552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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