- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646099
Sun Protection of Kidney Transplant Recipients
Internet-Based Sun Protection Program for Kidney Transplantation Recipients
Study Overview
Status
Intervention / Treatment
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:
- 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.
- To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
- To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Faculty Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sun Protection Education
Distribution of the internet-based sun protection educational program.
|
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.
|
No Intervention: Control
Distribution of general skin care information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of sun protection
Time Frame: 6 weeks
|
Use of sun protection will be measured using 10 questions about what a person regularly does in summer during a warm sunny day and during a cloudy day regarding: 1) use of sunscreen; 2) wearing hat; 3) shirt with sleeves; 4) sunglasses; and 5) staying in the shade.
The scores for these questions will be summed to derive a dichotomous measure of sun protection use (1= use of sun protection often or always; 0 otherwise).
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of sun burn or skin irritation from the sun
Time Frame: 6 weeks
|
Three telephone interviews will be done on Mondays after at least 2 holiday weekends in which the weather is reported as sunny or partly sunny by the national weather service (Memorial Day, 4th of July and Labor Day) as well as one sunny non-holiday weekend.
The KTR will be asked if they experienced a sunburn or skin irritation.
The response will be dichotomous (yes/no).
|
6 weeks
|
Forearm skin pigment
Time Frame: 6 weeks
|
Skin pigment as measured by reflectance spectrophotometry, ranging from limited [225 area-under-the-curve (AUIC)] to dense (75 AUIC).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: June K. Robinson, M.D., Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00058220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Disorder Related to Renal Transplantation
-
Ajou University School of MedicineCompletedDisorder Related to Renal TransplantationKorea, Republic of
-
University Hospital FreiburgRoche Pharma AG; Genzyme, a Sanofi Company; Astellas Pharma GmbHCompletedDisorder Related to Renal TransplantationGermany
-
Centre Hospitalier Universitaire de BesanconUnknownDisorder Related to Renal TransplantationFrance
-
Bristol-Myers SquibbCompletedDisorder Related to Renal TransplantationItaly, United States, Spain
-
Hospital Universitário São JoséUnknownDisorder Related to Renal TransplantationBrazil
-
Centre Hospitalier Universitaire de BesanconCompletedDisorder Related to Renal TransplantationFrance
-
Ajou University School of MedicineUnknownDisorder Related to Renal TransplantationKorea, Republic of
-
Centre Hospitalier Universitaire de BesanconUniversity Hospital, Lille; University Hospital, ToursRecruitingCancer | Disorder Related to Renal TransplantationFrance
-
Prof. Dr. Petra ReinkeCompletedDisorder Related to Renal Transplantation | Effects of Immunosuppressant TherapyGermany, France, Spain, Czechia, Netherlands, United Kingdom
-
Josep M CruzadoTerminatedMuscle Strength | Disorder Related to Renal Transplantation | Exercise, AerobicSpain
Clinical Trials on Internet-based sun protection education
-
Dana-Farber Cancer InstituteHarvard Medical School (HMS and HSDM); Brigham and Women's Hospital; University... and other collaboratorsCompleted
-
Northwestern UniversityCompletedSkin Cancer | Sun Sensitivity | Sun ProtectionUnited States
-
Ulla WalfridssonDept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.; Dept of...UnknownQuality of Life | Atrial Fibrillation | Signs and Symptoms | Health EconomySweden
-
Agency for Healthcare Research and Quality (AHRQ)Unknown
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); University of Alabama at Birmingham; Oregon...RecruitingProstate CarcinomaUnited States
-
University of OsloCompleted
-
NovoBliss Research Pvt LtdCompletedValidation of the Process of Skin TanningIndia
-
Akdeniz UniversityCompletedParents | Skin Neoplasms | Child Behavior | Health Behavior | Behavior and Behavior MechanismsTurkey
-
Centre Hospitalier Universitaire de la RéunionCompleted
-
Universidade Cidade de Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknown