NCT01452984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

October 13, 2011

Last Update Submit

March 18, 2015

Conditions

Keywords

Non-Melanoma skin cancer patients who have undergone or about to undergo Mohs surgerywho are treated within the University of Pennsylvania Health System

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Sarah Kagan, PhD, RN

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 17, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations