Clinical trial NCT01646099: Sun Protection of Kidney Transplant Recipients
Official title: Internet-Based Sun Protection Program for Kidney Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Complication of Kidney Transplant
Disorder Related to Renal Transplantation
Keywords: Kidney transplant
Renal transplant
Sun protection
Skin cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of sun protection
timeFrame: 6 weeks
Secondary outcomes:
measure: Level of sun burn or skin irritation from the sun
timeFrame: 6 weeks
measure: Forearm skin pigment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Faculty Foundation
state: Illinois
Study officials:
affiliation: Northwestern University
name: June K. Robinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.