NCT01127737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2 months until next milestone

Results Posted

Study results publicly available

June 1, 2011

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

3.6 years

First QC Date

May 19, 2010

Results QC Date

April 13, 2011

Last Update Submit

March 17, 2015

Conditions

Squamous Cell Carcinoma

Keywords

SCCsSquamous Cell CarcinomaSkin Self ExamSSEOrgan TransplantPerformance of SSE with our written educational interventionTime after organ transplantation to deliver interventionEvaluate internation information

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

PLACEBO COMPARATOR
Behavioral: Placebo

Intervention

ACTIVE COMPARATOR

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

Behavioral: Educational InterventionBehavioral: Placebo

Interventions

Educational InterventionBEHAVIORAL

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

Intervention
PlaceboBEHAVIORAL

Completed surveys

ControlIntervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • 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.

    PMID: 21339418RESULT

  • 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.

    PMID: 36472416DERIVED

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Limitations and Caveats

* Small sample at a single center for a limited period of follow-up * The dermatologists' assessment of the participants' concerning lesions was not performed

Results Point of Contact

Title
June Robinson, MD
Organization
Northwestern University
june-robinson@northwestern.edu
312-695-6624

Study Officials

  • Dennis P West, PhD

    Northwestern University

    STUDY CHAIR

  • June K Robinson, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dermatology

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 21, 2010

Study Start

September 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 3, 2015

Results First Posted

June 1, 2011

Record last verified: 2015-03

Locations

US(1)