NCT00374062

Brief Summary

The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

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

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

September 7, 2006

Last Update Submit

July 14, 2014

Conditions

Basal Cell CarcinomaSquamous Cell Carcinoma

Keywords

Mohs Surgery

Outcome Measures

Primary Outcomes (1)

  • Patient anxiety

    1 day

Secondary Outcomes (1)

  • Scar appearance

    12 weeks

Study Arms (3)

I

EXPERIMENTAL

relaxation tape 1

Behavioral: relaxation therapy 1

II

EXPERIMENTAL

relaxation tape 2

Behavioral: relaxation therapy 2

III

PLACEBO COMPARATOR

relaxation tape 3

Behavioral: relaxation therapy 3

Interventions

relaxation therapy 1BEHAVIORAL

relaxation therapy 1

I
relaxation therapy 2BEHAVIORAL

relaxation therapy 2

II
relaxation therapy 3BEHAVIORAL

relaxation therapy 3

III

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25 and older
  • Subjects are undergoing micrographic Mohs surgery for facial basal and squamous cell carcinoma.
  • The subjects are in good health.
  • The subjects have willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

You may not qualify if:

  • Subjects who have wound healing problems.
  • Subjects who have had prior Mohs surgery.
  • Subjects who are smokers.
  • Subjects who are currently using anticoagulation therapy
  • Subjects who have a history of bleeding disorders.
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders.
  • Subjects who are taking medications that may affect healing such as prednisone, or any immunosuppressants.
  • Subjects who are immunocompromised.
  • Subjects who have Diabetes Mellitus or any other condition determined by the PI to affect healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Murad Alam, MD

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous Cell

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

December 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

US(1)