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NCT04936906 Clinical Trial

Mohs Surgery: Patient Satisfaction & Quality of Life (QOL)

Quality of Life Clinical Trial

Official title:
Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04936906
Other study ID # 20180626
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2019
Est. completion date June 3, 2020

Study information
Verified date June 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine whether there is significant difference between two groups: extra care (EC) and usual care (UC) in improvement of patients' quality-of-life (QoL) scores between the baseline and 90-day post-surgery in patients undergoing Mohs micrographic surgery (MMS).

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 3, 2020
Est. primary completion date June 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female and/or male subjects undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) and/or Squamous Cell Carcinoma (SCC). 2. Subjects must be at least 18 years of age. Exclusion Criteria: 1. Subjects who are not able to complete the surveys (pre-surgery, 1 week post-surgery, and 3 months post- surgery) 2. Subjects under the age 18 3. Subjects unable to consent 4. Subjects who are not undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC).

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Extra Care (EC) Intervention
The EC intervention includes pre- and post- procedure calls from the surgeon, written educational material, personalized music during the operation, post-procedure skin cancer protection education, and are allowed to bring a guest into the procedure room.
Other:
• Usual Care (UC)
Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in PSQ Scores Patient Satisfaction Questionnaire (PSQ) is a 7 item questionnaire with a total score ranging from 7 to 35 with the higher score indicating greater satisfaction Baseline, 3 months
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