Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery
Primary Purpose
Non-melanoma Skin Cancer, Squamous Cell Carcinoma of Skin, Basal Cell Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Same-day preoperative consultation
Sponsored by
About this trial
This is an interventional health services research trial for Non-melanoma Skin Cancer focused on measuring Mohs surgery, Preoperative consultation
Eligibility Criteria
Inclusion Criteria:
- Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer
Exclusion Criteria:
- Patients would be excluded if there is a lack of indication for Mohs
- Significant comorbidities, or
- In the case of a high-risk location or tumor size, for which in advance it is known that they will need consultation with other specialties
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Separate-day preoperative consultation
Same-day preoperative consultation
Arm Description
Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation in advance of the day of the procedure.
Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation on the day same day as the procedure.
Outcomes
Primary Outcome Measures
Time to treatment
Assess the total amount of time elapsed between skin cancer diagnosis and defect repair
Time to consultation with other specialties
Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties
Time to repair
Assess the amount of time elapsed between cancer removal and defect repair
Patient satisfaction
Administer a survey to assess patient's perception of convenience, level of comfort with the procedure, and self-evaluation of knowledge regarding the diagnosis and treatment
Secondary Outcome Measures
Utilization rate of Mohs surgery
Assess the percentage of patients who actually proceed with undergoing Mohs surgery in each arm
Rate of case cancellation
Assess the number of cases that are cancelled due to site discrepancy, anticoagulation or other medical issues in each arm
Travel cost
Assess the total distance traveled by each patient coming and going to Mohs appointment(s)
Full Information
NCT ID
NCT02321982
First Posted
December 17, 2014
Last Updated
July 3, 2017
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02321982
Brief Title
Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery
Official Title
Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study topic is no longer being pursued by study team members
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether separate- versus same-day preoperative consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of case cancellations, cost, and patient satisfaction. The investigators hypothesize that patients with same-day preoperative consultation will have a shorter time between cancer diagnosis and removal but, only when coordination of care is needed, longer time between removal and consultation with other specialists, as compared to patients with separate-day consultation. The investigators anticipate that patients with same-day preoperative consultation will have a decrease in travel cost as compared to patients with separate-day consultation. The investigators expect that there will be no difference in various satisfaction matters between groups, with the exception of potentially greater convenience reported by patients in the same-day preoperative consultation group. Finally, the investigators hypothesize that there will be no difference between groups in regards to rates of surgery cancellation.
Detailed Description
Procedure: Prospective trial which randomly assigns patients to either separate- or same-day preoperative consultation for Mohs surgery. A phone consultation will take place, which will assist in determining whether the patient is appropriate for enrollment into the study. If so, the patient will be randomized to either separate-day or same-day preoperative consultation.
Materials: Patient survey
Methods of data collection: The patient-specific data obtained from the medical record will include: Patient age, number of previous skin cancers, preoperative size, history of cutaneous surgery, employment status, and distance between home address and dermatology facility. Outcome measures that will be obtained from the medical record will include: Time between cancer diagnosis, removal and defect repair, rate of proceeding with Mohs as opposed to other treatment options, and rate of cancelling surgery (due to site discrepancy, anticoagulation issues). A survey will be used to assess patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer, Squamous Cell Carcinoma of Skin, Basal Cell Carcinoma
Keywords
Mohs surgery, Preoperative consultation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Separate-day preoperative consultation
Arm Type
No Intervention
Arm Description
Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation in advance of the day of the procedure.
Arm Title
Same-day preoperative consultation
Arm Type
Experimental
Arm Description
Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation on the day same day as the procedure.
Intervention Type
Other
Intervention Name(s)
Same-day preoperative consultation
Intervention Description
Preoperative consultation occurs on the same day as Mohs surgery
Primary Outcome Measure Information:
Title
Time to treatment
Description
Assess the total amount of time elapsed between skin cancer diagnosis and defect repair
Time Frame
Eight weeks
Title
Time to consultation with other specialties
Description
Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties
Time Frame
Eight weeks
Title
Time to repair
Description
Assess the amount of time elapsed between cancer removal and defect repair
Time Frame
Eight weeks
Title
Patient satisfaction
Description
Administer a survey to assess patient's perception of convenience, level of comfort with the procedure, and self-evaluation of knowledge regarding the diagnosis and treatment
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Utilization rate of Mohs surgery
Description
Assess the percentage of patients who actually proceed with undergoing Mohs surgery in each arm
Time Frame
Eight weeks
Title
Rate of case cancellation
Description
Assess the number of cases that are cancelled due to site discrepancy, anticoagulation or other medical issues in each arm
Time Frame
Eight weeks
Title
Travel cost
Description
Assess the total distance traveled by each patient coming and going to Mohs appointment(s)
Time Frame
Eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer
Exclusion Criteria:
Patients would be excluded if there is a lack of indication for Mohs
Significant comorbidities, or
In the case of a high-risk location or tumor size, for which in advance it is known that they will need consultation with other specialties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faramarz Samie, MD, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery
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