Evaluation of Sun Protection Education for Kidney Transplant Recipients

NCT ID: NCT01844713

Last Updated: 2014-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unspecified Complications of Kidney Transplant Disorder Related to Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Workbook

Distribution of the sun protection educational workbook

Group Type EXPERIMENTAL

Workbook

Intervention Type BEHAVIORAL

Subjects will read a workbook about sun protection

Control

Distribution of general skin care information

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Workbook

Subjects will read a workbook about sun protection

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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June Robinson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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June K. Robinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Faculty Foundation

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00069552

Identifier Type: -

Identifier Source: org_study_id

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