Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Using focus group and cognitive interviews with organ transplant recipients, the investigators developed interactive workbooks: a) prevention by sun protection b) early detection by skin self-examination (SSE). The investigators hypothesis is if the patient learns by acquiring skills in a favorable environment, then the patient may reduce their anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The investigators also evaluate existing internet sources of primary and secondary prevention of skin cancer for organ transplant recipients.

Official Title
-----------------
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients

Conditions
-----------------
Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Behavioral: Educational Intervention
* Behavioral: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with a history of solid organ transplantation within the last 2 years Speaks English Can see to do SSE, capable of seeing to read a newspaper Stable health, patients report a general state of well being Exclusion Criteria: Unable to speak English Insufficient vision to see their own skin as determined by their ability to read a newspaper Comorbid debilitating disease Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Behavioral: Placebo<br>* Completed surveys<br>|
| Active Comparator: Intervention<br>Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs. | Behavioral: Educational Intervention<br>* Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.<br>Behavioral: Placebo<br>* Completed surveys<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention | The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCCs, Squamous Cell Carcinoma, Skin Self Exam, SSE, Organ Transplant, Performance of SSE with our written educational intervention, Time after organ transplantation to deliver intervention, Evaluate internation information