Clinical trial NCT03756792: Assessing Patient Anxiety During Mohs Micrographic Surgery
Official title: Assessing Patient Anxiety During Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Mohs Micographic Surgery
skin cancer
melanoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will assess the anxiety that patients are experiencing during a Mohs micrographic surgery. The study will compare the feelings of anxiety experienced by patients returning for Mohs surgery after already undergoing the surgery at least one time to feelings experienced by patients who have never had Mohs surgery before. The study will also compare the feelings experienced by patients who have read a vignette about the typical Mohs experience to the feelings of patients who have not read a vignette.

Detailed description: There has been a continual increase in cases of nonmelanoma skin cancer and melanoma over the last several decades. With the increase in incidence, there is also the need for increased treatment. Mohs micrographic surgery (MMS) is highly efficacious, with cure rates in the upper 90% for both basal cell carcinoma and squamous cell carcinoma, the two most common forms of skin cancer. MMS is used for tumors in cosmetically sensitive areas or areas of recurrence.

While MMS is usually performed in the outpatient setting, it may be an anxiety provoking experience for patients, ranging from the fear of a cancer diagnosis, to concerns about the procedural events of the surgery and associated pain, to the anticipation of their final cosmetic result. During a MMS procedure, unlike many other types of surgery or procedures, the patient is awake and aware of his or her surroundings, with periods of waiting interspersed throughout the procedure. Such aspects can lead to the high level of perioperative anxiety in MMS patients. The effects of listening to music, watching preoperative informational videos, and the use of web-based applications have been used to attempt to decrease anxiety in MMS patients. However, causes for differences in anxiety level between first time MMS patients and patients returning for a subsequent MMS procedure are not well characterized.

One approach to reduce patient anxiety involves patient education, where patients are presented statistics about the small likelihood of complication from the MMS procedure. However, patients interpret these data very subjectively. The study team proposes an alternative approach to patient education through patient vignettes. A previous study explored using a narrative video that included patient testimonials, but this video also used patient-physician interaction and drawings. In this study, patients will be provided short vignettes, that would include information about the experience of a typical MMS patient.

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing Mohs micrographic surgery for cutaneous cancer, soft tissue tumors, and adnexal tumors
* Subjects with a working knowledge of English
* Age 18-80

Exclusion Criteria:

* Patients unable to fill out a paper or electronic survey or read a short pamphlet on prior patient experiences, or those unwilling to have either of the previously stated items read aloud to them.
* Individuals less than 18 or greater than 80 years old (line of questioning necessary for the study may be beyond understanding in this group)

Primary outcomes:
measure: Visual Analog Scale for Anxiety Scores
timeFrame: up to 10 minutes
measure: Visual Analog Scale Scores
timeFrame: up to 10 minutes
measure: Survey to identify factors that modify anxiety - Positive statements
timeFrame: up to 10 minutes
measure: Survey to identify factors that modify anxiety - Negative statements
timeFrame: up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
citation: Dubas LE, Ingraffea A. Nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2013 Feb;21(1):43-53. doi: 10.1016/j.fsc.2012.10.003.
citation: Kamangar F, Petukhova TA, Monico G, Mathis S, Joo J, Zhuang A, Li CS, Liu Y, Lee E, Eisen D. Anxiety levels of patients undergoing common dermatologic procedures versus those seeking general dermatologic care. Dermatol Online J. 2017 May 15;23(5):13030/qt64d8r1gq.
citation: Persichetti GB, Walling HW, Ceilley RI. Personalized music enhances patient perception of the Mohs surgery experience. Dermatol Surg. 2009 Feb;35(2):265-7. doi: 10.1111/j.1524-4725.2008.34422.x. No abstract available.
citation: Vachiramon V, Sobanko JF, Rattanaumpawan P, Miller CJ. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. Dermatol Surg. 2013 Feb;39(2):298-305. doi: 10.1111/dsu.12047. Epub 2013 Jan 24.
citation: Newsom E, Lee E, Rossi A, Dusza S, Nehal K. Modernizing the Mohs Surgery Consultation: Instituting a Video Module for Improved Patient Education and Satisfaction. Dermatol Surg. 2018 Jun;44(6):778-784. doi: 10.1097/DSS.0000000000001473.
citation: Hawkins SD, Koch SB, Williford PM, Feldman SR, Pearce DJ. Web App- and Text Message-Based Patient Education in Mohs Micrographic Surgery-A Randomized Controlled Trial. Dermatol Surg. 2018 Jul;44(7):924-932. doi: 10.1097/DSS.0000000000001489.
citation: Zhang J, Miller CJ, O'Malley V, Etzkorn JR, Shin TM, Sobanko JF. Patient quality of life fluctuates before and after Mohs micrographic surgery: A longitudinal assessment of the patient experience. J Am Acad Dermatol. 2018 Jun;78(6):1060-1067. doi: 10.1016/j.jaad.2018.02.065. Epub 2018 Mar 5.
citation: Locke MC, Wilkerson EC, Mistur RL, Nisar M, Love WE. 2015 Arte Poster Competition First Place Winner: Assessing the Correlation Between Patient Anxiety and Satisfaction for Mohs Surgery. J Drugs Dermatol. 2015 Sep;14(9):1070-2.