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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Behavioral | Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis P West, PhD | Northwestern University | Study Chair |
| June K Robinson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21339418 | Result | 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. | |
| 36472416 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit. |
| FG001 | Intervention | Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit. |
| BG001 | Intervention | Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol | Posted | Apr 2011 | Number | Participants | 1 month |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| June Robinson, MD | Northwestern University | 312-695-6624 | june-robinson@northwestern.edu |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Placebo | Behavioral | Completed surveys |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Intervention | Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs. | 0 | 38 | 0 | 38 |
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| D018307 |
| Neoplasms, Squamous Cell |
| D011314 | Preventive Health Services |