Trial Outcomes & Findings for Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients (NCT NCT01127737)

NCT ID: NCT01127737

Last Updated: 2015-04-03

Results Overview

The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2015-04-03

Participant Flow

Subjects were recruited from Northwestern University's kidney transplant recipient population. Participants were returning for routine care to their nephrologists 1 to 1.2 years or 3 to 7 years after transplantation.

Participant milestones

Measure	Control Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.	Intervention Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
Overall Study STARTED	37	38
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control n=37 Participants Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.	Intervention n=38 Participants Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.	Total n=75 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	61 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Per protocol

The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.

Outcome measures

Measure	Intervention n=38 Participants Educational intervention consisting of a mnemonic and a workboook	Placebo n=37 Participants
Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention	34 Participants	8 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

June Robinson, MD

Northwestern University

Phone: 312-695-6624

Email: june-robinson@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place