Sun Protection of Kidney Transplant Recipients

NCT ID: NCT01646099

Last Updated: 2015-04-23

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

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unspecified Complication 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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Sun Protection Education

Distribution of the internet-based sun protection educational program.

Group Type EXPERIMENTAL

Internet-based sun protection education

Intervention Type BEHAVIORAL

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.

Control

Distribution of general skin care information.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
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

Research Professor of Dermatology

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

References

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Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

Reference Type DERIVED
PMID: 36472416 (View on PubMed)

Robinson JK, Friedewald JJ, Desai A, Gordon EJ. Response Across the Health-Literacy Spectrum of Kidney Transplant Recipients to a Sun-Protection Education Program Delivered on Tablet Computers: Randomized Controlled Trial. JMIR Cancer. 2015 Aug 18;1(2):e8. doi: 10.2196/cancer.4787.

Reference Type DERIVED
PMID: 28410176 (View on PubMed)

Robinson JK, Guevara Y, Gaber R, Clayman ML, Kwasny MJ, Friedewald JJ, Gordon EJ. Efficacy of a sun protection workbook for kidney transplant recipients: a randomized controlled trial of a culturally sensitive educational intervention. Am J Transplant. 2014 Dec;14(12):2821-9. doi: 10.1111/ajt.12932. Epub 2014 Nov 13.

Reference Type DERIVED
PMID: 25395386 (View on PubMed)

Guevara Y, Gaber R, Clayman ML, Gordon EJ, Friedewald J, Robinson JK. Sun protection education for diverse audiences: need for skin cancer pictures. J Cancer Educ. 2015 Mar;30(1):187-9. doi: 10.1007/s13187-014-0661-7.

Reference Type DERIVED
PMID: 24788983 (View on PubMed)

Other Identifiers

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STU00058220

Identifier Type: -

Identifier Source: org_study_id

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