Experience of Non-Melanoma Skin Cancer (NMSC) Mohs Surgery Project

This study is currently recruiting participants.
Verified May 2012 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01452984
First received: October 13, 2011
Last updated: February 25, 2013
Last verified: May 2012
  Purpose

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.


Condition
Non-Melanoma Skin Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Experience of Patients With Non-Melanoma Skin Cancer of the Head and Neck Undergoing Mohs Surgery

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single Retrospective Interviews
Each retrospective interview will be conducted by the Principal Investigator and/or Project Manager to collect denmographic information and experiential narratives from the patient, using open-ended questions and structured probes based on individual responses. Retrospective interviews will be recorded and scheduled at the patients' convenience either in the clinic, at the home, or at a place that is convenient to them.
Prospective Observations
Prospective Observations of clinic visits will be combined with informal interview to document conversations with their treating physicians about concerns emerging from appearance, function, and other factors that may impinge on clinical decision making and experience including quality of life. The Project Manager will be present for the clinical visit during which the Mohs surgery takes place and record field observations as well as informal interview notes in a notebook.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452984

Contacts
Contact: Sarah Kagan, PhD, RN 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sarah Kagan, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Sarah Kagan, PhD, RN         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Sarah Kagan, PhD, RN Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01452984     History of Changes
Other Study ID Numbers: UPCC 07311
Study First Received: October 13, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Non-Melanoma skin cancer patients who have undergone or about to undergo Mohs surgery
who are treated within the University of Pennsylvania Health System

Additional relevant MeSH terms:
Skin Neoplasms
Head and Neck Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on April 23, 2014