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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01127737
Other study ID # JKR-090607
Secondary ID
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


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
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