NCT02321982

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.

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 Feb 2015

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

December 17, 2014

Last Update Submit

July 3, 2017

Conditions

Non-melanoma Skin CancerSquamous Cell Carcinoma of SkinBasal Cell Carcinoma

Keywords

Mohs surgeryPreoperative consultation

Outcome Measures

Primary Outcomes (4)

  • Time to treatment

    Assess the total amount of time elapsed between skin cancer diagnosis and defect repair

    Eight weeks

  • Time to consultation with other specialties

    Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties

    Eight weeks

  • Time to repair

    Assess the amount of time elapsed between cancer removal and defect repair

    Eight weeks

  • 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 Outcomes (3)

  • Utilization rate of Mohs surgery

    Eight weeks

  • Rate of case cancellation

    Eight weeks

  • Travel cost

    Eight weeks

Study Arms (2)

Separate-day preoperative consultation

NO INTERVENTION

Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation in advance of the day of the procedure.

Same-day preoperative consultation

EXPERIMENTAL

Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation on the day same day as the procedure.

Other: Same-day preoperative consultation

Interventions

Same-day preoperative consultationOTHER

Preoperative consultation occurs on the same day as Mohs surgery

Same-day preoperative consultation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Faramarz Samie, MD, PhD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

February 1, 2015

Primary Completion

June 29, 2017

Study Completion

June 29, 2017

Last Updated

July 6, 2017

Record last verified: 2017-07