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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT04936906
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	Behavioral: Extra Care (EC) Intervention; Other: Usual Care (UC)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery
• Actual Study Start Date: Jul 2, 2019
• Actual Primary Completion Date: Jun 3, 2020
• Actual Study Completion Date: Jun 3, 2020

Arms and Interventions

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.	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.
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.	Other: Usual Care (UC); Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.

Outcome Measures

Primary Outcome Measures

1. Change in PSQ Scores [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Keyvan Nouri, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keyvan Nouri, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04936906
• Other Study ID Numbers: 20180626
• First Posted: Jun 23, 2021
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 23, 2021