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

NCT ID: NCT04936906

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-02

Study Completion Date

2020-06-03

Brief Summary

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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).

Detailed Description

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Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Extra Care (EC) Treatment Group

Participants in this group will receive the EC intervention pre and post standard of care (SoC) scheduled Mohs Surgery.

Group Type EXPERIMENTAL

Extra Care (EC) Intervention

Intervention Type BEHAVIORAL

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.

Usual Care (UC) Group

Participants in this group will receive the usual care provided to patients undergoing standard of care (SoC) scheduled Mohs Surgery.

Group Type ACTIVE_COMPARATOR

Usual Care (UC)

Intervention Type OTHER

Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care (UC)

Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Keyvan Nouri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keyvan Nouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20180626

Identifier Type: -

Identifier Source: org_study_id

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