NCT04612491

Brief Summary

To determine if in-office pre-operative consultation has a significant effect on the anxiety level and overall post-operative satisfaction of patients undergoing first time Mohs surgery

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

September 6, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

October 27, 2020

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The score on the PSQ-18 survey following the Mohs procedure

    The PSQ-18 (aka patient satisfaction questionaire-18) is a validated assessment tool developed to measure holistic patient satisfaction with the aspects of clinical care (assessing six domains of patient satisfaction: technical quality, interpersonal manner, communication, financial aspects of care, accessibility of care and time spent with the physician), and by virtue of its brevity (18 questions taking an average of 3-4 minutes to complete) has great utility for measuring patient satisfaction in the clinical setting. Each question ranges from 1-5. Lower scores are better. The primary null hypothesis for this study is that mean PSQ-18 survey scores do not differ between patients receiving pre-operative consultation versus those not receiving this intervention.

    2 years

Secondary Outcomes (1)

  • Patient anxiety as measured on the 10-point VAS scale for anxiety

    2 years

Study Arms (2)

Pre-operative Consultation

Behavioral: Pre-operative Consultation

No consultation

Interventions

Pre-operative consultation will be given before Mohs surgery

Pre-operative Consultation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at r the UC Davis Dermatology Clinic who are scheduled for the Mohs procedure.

You may qualify if:

  • Adults 18 years old or older
  • Able to provide consent for participation
  • Fluency in English
  • Presenting for first-time Mohs surgery for treatment of a cutaneous malignancy

You may not qualify if:

  • Patients under 18 years old
  • Prisoners
  • Patients unable to provide consent
  • History of prior Mohs surgery
  • Patients requiring multi-disciplinary care (i.e. Involvement of other surgical specialties such as Plastic Surgery or Ophthalmology for reconstruction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 3, 2020

Study Start

September 6, 2019

Primary Completion

June 3, 2020

Study Completion

March 15, 2024

Last Updated

June 14, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations