search
Back to results

Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients (SCCs in OTRs)

Primary Purpose

Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Squamous Cell Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Intervention

Arm Description

Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2010
Last Updated
March 17, 2015
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT01127737
Brief Title
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Acronym
SCCs in OTRs
Official Title
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Intervention Description
Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Completed surveys
Primary Outcome Measure Information:
Title
Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention
Description
The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis P West, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
June K Robinson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21339418
Citation
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 Jun;147(6):689-95. doi: 10.1001/archdermatol.2011.10. Epub 2011 Feb 21.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs