Evaluation of Sun Protection Education for Kidney Transplant Recipients

Disorder Related to Renal Transplantation Clinical Trial

Official title:

Evaluation of Sun Protection Education for Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844713
• Other study ID #: STU00069552
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: July 30, 2014
• Start date: May 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation
• Unspecified Complications of Kidney Transplant

Intervention

Behavioral:
• Workbook
Subjects will read a workbook about sun protection

Locations

Country	Name	City	State
United States	Northwestern Memorial Faculty Foundation	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of sun protection	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	No