- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936906
Mohs Surgery: Patient Satisfaction & Quality of Life (QOL)
June 15, 2021 updated by: Keyvan Nouri, University of Miami
Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PSQ Scores
Time Frame: Baseline, 3 months
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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
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Baseline, 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2019
Primary Completion (Actual)
June 3, 2020
Study Completion (Actual)
June 3, 2020
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 15, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 20180626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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