Evaluation of Sun Protection Education for Kidney Transplant Recipients

Northwestern University

Status: Completed

Conditions: Disorder Related to Renal Transplantation; Unspecified Complications of Kidney Transplant

Treatments: Behavioral: Workbook

Study type: Interventional

Funder types: Other

Identifiers

NCT01844713

STU00069552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

Experimental: Workbook

Experimental group

Description:

Distribution of the sun protection educational workbook

Treatment:

Behavioral: Workbook

Control

No Intervention group

Description:

Distribution of general skin care information