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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Withdrawn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
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 17, 2014
    Last Updated
    July 3, 2017
    Sponsor
    Dartmouth-Hitchcock Medical Center
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    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

    Learn more about this trial

    Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery

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