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

Squamous Cell Carcinoma Clinical Trial

— SCCs in OTRs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127737
• Other study ID #: JKR-090607
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: March 17, 2015
• Start date: September 2007
• Est. completion date: April 2011

Study information

• Verified date: March 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Behavioral:
• Educational Intervention
Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.
• Placebo
Completed surveys

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Robinson JK, Turrisi R, Mallett KA, Stapleton J, Boone SL, Kim N, Riyat NV, Gordon EJ. Efficacy of an educational intervention with kidney transplant recipients to promote skin self-examination for squamous cell carcinoma detection. Arch Dermatol. 2011 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No