Experience of Non-Melanoma Skin Cancer (NMSC) Mohs Surgery Project
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 13, 2011 | ||||
| Last Updated Date | February 25, 2013 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01452984 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Experience of Non-Melanoma Skin Cancer (NMSC) Mohs Surgery Project | ||||
| Official Title ICMJE | Experience of Patients With Non-Melanoma Skin Cancer of the Head and Neck Undergoing Mohs Surgery | ||||
| Brief Summary | Mohs surgery excises non-melanoma skin cancer tumors of the head and neck while preserving maximum healthy tissue, an advantageous characteristic when dealing with the cosmetic and functional cervifacial region. Yet, treatment can result in changes to function and appearance with effects on quality of life. This project uses Grounded Theory to explore the Mohs surgery experience of NMSC patients who have head and neck lesions through interview and observation of the surgical appointment. |
||||
| Detailed Description | Mohs surgery offers significant benefits in excising NMSC tumors of the head and neck by precisely removing cancerous tissue while preserving the maximum amount of healthy tissue, a characteristic of particular advantage when dealing with NMSC in the highly cosmetic and functional cericofacial region. Despite this, few studies have explored the patient perspective on their experience with Mohs surgery. Futhermore, treatment for NMSC can result in scarring, disfigurement, and changes to function and appearance. Ramifications on identity and self, embodiment and aesthetics, interaction and relationships appear likely and consequences on function and quality of life might then follow. Using Grounded Theory, this project aims to explore the question "what is the experience of Mohs surgery for non-melanoma skin cancer patients who have lesions of the head and neck?" Potential patient participants are those diagnosed with non-melanoma skin cancer, who have undergone Mohs surgery or are scheduled to undergo Mohs surgery on skin located in any area above the shoulders, and are referred to the project by their surgeons. They will represent a range of disease, from those who have had a single Mohs surgery to those with recurrent NMSC and repeated Mohs. Patients will also read and speak English and be at least 18 years of age. Transcribed interviews and field notes will be analyzed using constant comparative technique to develop descriptive and theoretical understandings of how experience Mohs surgery for non-melanoma skin cancer of the head and nexk. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | This study involves non-melanoma skin cancer patients who have undergone or are about to undergo Mohs surgery, who are treated within the University of Pennsylvania Health System. |
||||
| Condition ICMJE | Non-Melanoma Skin Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01452984 | ||||
| Other Study ID Numbers ICMJE | UPCC 07311 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Abramson Cancer Center of the University of Pennsylvania | ||||
| Study Sponsor ICMJE | Abramson Cancer Center of the University of Pennsylvania | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Abramson Cancer Center of the University of Pennsylvania | ||||
| Verification Date | May 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||