Non-melanoma Skin CancerNCT02321982
Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery
A study testing Same-day preoperative consultation in people with Non-melanoma Skin Cancer and Squamous Cell Carcinoma of Skin, run by Dartmouth-Hitchcock Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-melanoma Skin Cancer, Squamous Cell Carcinoma of Skin, Basal Cell Carcinoma
- What is being tested?
- Same-day preoperative consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to 29 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- Same-day preoperative consultation
- Keywords
- Mohs surgery, Preoperative consultation
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day preoperative consultationOther
Preoperative consultation occurs on the same day as Mohs surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Same-day preoperative consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment
Assess the total amount of time elapsed between skin cancer diagnosis and defect repair
Measured: Eight weeks
Time to consultation with other specialties
Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties
Measured: Eight weeks
Time to repair
Assess the amount of time elapsed between cancer removal and defect repair
Measured: 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
Measured: Eight weeks
Secondary outcomes (3)
Utilization rate of Mohs surgery
Assess the percentage of patients who actually proceed with undergoing Mohs surgery in each arm
Measured: Eight weeks
Rate of case cancellation
Assess the number of cases that are cancelled due to site discrepancy, anticoagulation or other medical issues in each arm
Measured: Eight weeks
Travel cost
Assess the total distance traveled by each patient coming and going to Mohs appointment(s)
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Why it stopped: Study topic is no longer being pursued by study team members
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faramarz Samie, MD, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321982
- Sponsor's protocol ID
- D15025
- Status last verified
- Jul 2017
- First submitted
- 17 Dec 2014
- Last updated
- 6 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery
- ClinicalTrials.gov ID
- NCT02321982
- Acronym / sponsor ID
- D15025
- Keywords
- Mohs surgery, Preoperative consultation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study topic is no longer being pursued by study team members
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Same-day preoperative consultationPatients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation on the day same day as the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same-day preoperative consultationPreoperative consultation occurs on the same day as Mohs surgery | Other | Same-day preoperative consultation |
Primary outcome
Time to treatment
Time frame: Eight weeks
Assess the total amount of time elapsed between skin cancer diagnosis and defect repair
Time to consultation with other specialties
Time frame: Eight weeks
Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties
Time to repair
Time frame: Eight weeks
Assess the amount of time elapsed between cancer removal and defect repair
Patient satisfaction
Time frame: Eight weeks
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
3 secondary outcomes
Utilization rate of Mohs surgery
Time frame: Eight weeks
Rate of case cancellation
Time frame: Eight weeks
Travel cost
Time frame: Eight weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faramarz Samie, MD, PhD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Same-day preoperative consultation in people with Non-melanoma Skin Cancer and Squamous Cell Carcinoma of Skin, run by Dartmouth-Hitchcock Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment (time frame: Eight weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.