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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452984
Other study ID # UPCC 07311
Secondary ID
Status Completed
Phase N/A
First received October 13, 2011
Last updated March 18, 2015
Start date July 2011
Est. completion date December 2013

Study information

Verified date March 2015
Source Abramson Cancer Center of the University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient participants must have an upcoming Mohs surgery scheduled or have already undergone Mohs surgery within the University of Pennsylvania Health System.

- All participants must read and speak English.

- For those patient participants with communication impairments due to surgery and treatment, accomodations for alternate methods of communication, including typing responses to the interview guide into a laptop computer or writing responses with a pen on paper, will be provided.

- Both male and female

- Must read and speak English

- Be over the age 18 and able to give consent.

Exclusion Criteria:

- This study excludes patients and their partners who are incapacitated or not old enough to give consent, more specifically those under the age of 18.

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events
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