Mohs Surgery: Patient Satisfaction & Quality of Life (QOL)
Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery
1 other identifier
interventional
40
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Jul 2019
1 active site
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 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedFirst Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedJune 23, 2021
June 1, 2021
11 months
June 15, 2021
June 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Extra Care (EC) Treatment Group
EXPERIMENTALParticipants in this group will receive the EC intervention pre and post standard of care (SoC) scheduled Mohs Surgery.
Usual Care (UC) Group
ACTIVE COMPARATORParticipants in this group will receive the usual care provided to patients undergoing standard of care (SoC) scheduled Mohs Surgery.
Interventions
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.
Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.
Eligibility Criteria
You may qualify if:
- Female and/or male subjects undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) and/or Squamous Cell Carcinoma (SCC).
- Subjects must be at least 18 years of age.
You may not qualify if:
- Subjects who are not able to complete the surveys (pre-surgery, 1 week post-surgery, and 3 months post- surgery)
- Subjects under the age 18
- Subjects unable to consent
- Subjects who are not undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keyvan Nouri, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2021
First Posted
June 23, 2021
Study Start
July 2, 2019
Primary Completion
June 3, 2020
Study Completion
June 3, 2020
Last Updated
June 23, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share