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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02321982
• Other study ID #: D15025
• Status: Withdrawn
• Phase: N/A
• First received: December 17, 2014
• Last updated: July 3, 2017
• Start date: February 2015
• Est. completion date: June 29, 2017

Study information

• Verified date: July 2017
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Non-melanoma Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma of Skin

Intervention

Other:
• Same-day preoperative consultation
Preoperative consultation occurs on the same day as Mohs surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment	Assess the total amount of time elapsed between skin cancer diagnosis and defect repair	Eight weeks
Primary	Time to consultation with other specialties	Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties	Eight weeks
Primary	Time to repair	Assess the amount of time elapsed between cancer removal and defect repair	Eight weeks
Primary	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	Eight weeks
Secondary	Utilization rate of Mohs surgery	Assess the percentage of patients who actually proceed with undergoing Mohs surgery in each arm	Eight weeks
Secondary	Rate of case cancellation	Assess the number of cases that are cancelled due to site discrepancy, anticoagulation or other medical issues in each arm	Eight weeks
Secondary	Travel cost	Assess the total distance traveled by each patient coming and going to Mohs appointment(s)	Eight weeks