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).
Full Title of Study: “Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: June 3, 2020
- 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.
Arms, Groups and Cohorts
- Experimental: Extra Care (EC) Treatment Group
- Participants in this group will receive the EC intervention pre and post standard of care (SoC) scheduled Mohs Surgery.
- Active Comparator: Usual Care (UC) Group
- Participants in this group will receive the usual care provided to patients undergoing standard of care (SoC) scheduled Mohs Surgery.
Clinical Trial Outcome Measures
- Change in PSQ Scores
- Time Frame: Baseline, 3 months
- 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
Participating in This Clinical Trial
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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Miami
- Provider of Information About this Clinical Study
- Principal Investigator: Keyvan Nouri, Professor – University of Miami
- Overall Official(s)
- Keyvan Nouri, MD, Principal Investigator, University of Miami
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