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

NCT ID: NCT01127737

Last Updated: 2015-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Completed surveys

Intervention

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

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type BEHAVIORAL

Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.

Placebo

Intervention Type BEHAVIORAL

Completed surveys

Interventions

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Educational Intervention

Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.

Intervention Type BEHAVIORAL

Placebo

Completed surveys

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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June Robinson

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis P West, PhD

Role: STUDY_CHAIR

Northwestern University

June K Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21339418 (View on PubMed)

Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

Reference Type DERIVED
PMID: 36472416 (View on PubMed)

Other Identifiers

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JKR-090607

Identifier Type: -

Identifier Source: org_study_id

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