Squamous Cell CarcinomaSCCs in OTRsNCT01127737
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
A study testing Educational Intervention in people with Squamous Cell Carcinoma, run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Educational Intervention, Placebo
- 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
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.
PlaceboBehavioural
Completed surveys
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: 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. Receives: Behavioral: Educational Intervention; Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startSep 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- Dennis P West, PhD, Study chair, Northwestern UniversityJune K Robinson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127737
- Sponsor's protocol ID
- JKR-090607
- Acronym
- SCCs in OTRs
- Status last verified
- Mar 2015
- First submitted
- 19 May 2010
- Last updated
- 3 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21339418Campbell 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.
PubMed 36472416
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT01127737
- Acronym / sponsor ID
- SCCs in OTRs / JKR-090607
- Conditions
- Squamous Cell Carcinoma
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Posted 1 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Placebo |
| Intervention | Active comparator | Behavioral: Educational Intervention, Behavioral: PlaceboEducational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionMnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs. | Behavioural | Intervention |
| PlaceboCompleted surveys | Behavioural | Control, Intervention |
Primary outcome
Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention
Time frame: 1 month
The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21339418Robinson 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.
- Derived from this study: PubMed 36472416Campbell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis P West, PhD study chair
Northwestern University
June K Robinson, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Squamous Cell Carcinoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.