Squamous Cell Carcinoma
Conditions
Keywords
SCCs, Squamous Cell Carcinoma, Skin Self Exam, SSE, Organ Transplant, Performance of SSE with our written educational intervention, Time after organ transplantation to deliver intervention, Evaluate internation information
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.
Interventions
BEHAVIORALEducational Intervention
Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.
BEHAVIORALPlacebo
Completed surveys
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention | 1 month | The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit. | 37 |
| Intervention Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs. | 38 |
| Total | 75 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 58 years | 61 years | 60 years |
| Region of Enrollment United States | 37 participants | 38 participants | 75 participants |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 32 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
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.
Time frame: 1 month
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention | 34 Participants |
| Placebo | Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention | 8 Participants |