NCT01844713

Brief Summary

This study is being done to evaluate the effectiveness of a Sun Protection Strategies workbook for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at an increased risk of developing skin cancer. The program will help people learn about how to practice effective sun protection after the transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

April 29, 2013

Last Update Submit

July 30, 2014

Conditions

Unspecified Complications of Kidney TransplantDisorder Related to Renal Transplantation

Keywords

Kidney transplantRenal transplantSun protectionSkin cancer

Outcome Measures

Primary Outcomes (1)

  • use of sun protection

    Subjects will complete self-report surveys of behavior prior to educational intervention and 6- 8 weeks after the educational intervention

    An average of 1 year

Study Arms (2)

Experimental: Workbook

EXPERIMENTAL

Distribution of the sun protection educational workbook

Behavioral: Workbook

Control

NO INTERVENTION

Distribution of general skin care information

Interventions

WorkbookBEHAVIORAL

Subjects will read a workbook about sun protection

Experimental: Workbook

Eligibility Criteria

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

You may qualify if:

  • Subjects with a history of kidney transplantation within the last 2-24 months
  • Speaks English
  • Can see to read
  • Lives in the greater Chicago area and can attend two study visits
  • years old

You may not qualify if:

  • Unable to speak English
  • Cognitive impairment or neurologic disease
  • Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level
  • Has had a skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Faculty Foundation

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • June K. Robinson, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 1, 2014

Record last verified: 2014-07

Locations

US(1)