NCT03485937

Brief Summary

The purpose of this research is to look at how educational videos might affect patient satisfaction and anxiety before Mohs surgery day. Patients will be randomized to either: 1) a group that receives educational videos before the visit in addition to standard-of-care written and verbal instructions OR 2) a group that receives only standard-of-care written and verbal instructions.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

March 27, 2018

Last Update Submit

October 21, 2019

Conditions

Keywords

anxietypatient satisfactionvideo educationskin cancerlinear closure on the face

Outcome Measures

Primary Outcomes (2)

  • Difference in mean Likert scale rating of subject satisfaction score

    For subject satisfaction score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a six item instrument with individual scores ranging from 1-5 (total score 6-30). Higher scores indicate greater satisfaction.

    Up to 8 weeks after visit

  • Difference in mean Likert scale rating of subject anxiety score

    For subject anxiety score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a seven item instrument with individual scores ranging from 1-5 with positive worded items scored in reverse (total score 7-35). Higher scores indicate greater anxiety

    Up to 8 weeks after visit

Study Arms (2)

Pre-Operative Videos + verbal/written instructions

EXPERIMENTAL

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions.

Behavioral: Pre-Operative VideosBehavioral: verbal instructionsBehavioral: written instructions

verbal/written instructions

ACTIVE COMPARATOR

This arm will receive the standard-of-care verbal/written instructions and the pre-operative video explanation. These instructions contain the same content as in the pre-operative videos

Behavioral: verbal instructionsBehavioral: written instructions

Interventions

Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions. The videos will be split into two modules: 1) preparing for Mohs Surgery 2) Mohs Surgery Walk through. The intervention, in the form of a video walk through, will be provided to the patient via email prior to their surgical procedure once they schedule an appointment with the Mohs clinic for their surgery day.

Pre-Operative Videos + verbal/written instructions

As part of the standard of care for patients receiving Mohs surgery, patients are told about the day of their surgery and what to expect

Pre-Operative Videos + verbal/written instructionsverbal/written instructions

As part of the standard of care for patients receiving Mohs surgery, patients receive written material about the day of their surgery and what to expect

Pre-Operative Videos + verbal/written instructionsverbal/written instructions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are at the University Hospitals Cleveland Medical Center Mohs Clinic to undergo a linear closure on the face.
  • Fluent English speakers

You may not qualify if:

  • Non-fluent English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersPatient SatisfactionSkin Neoplasms

Condition Hierarchy (Ancestors)

Mental DisordersTreatment Adherence and ComplianceHealth BehaviorBehaviorNeoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeremy S. Bordeaux, MD, MPH

    University Hospitals, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

June 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10