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Patient Satisfaction After Facial Reconstruction

Primary Purpose

Skin Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Viewing of cancer excision defect
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Neoplasms focused on measuring patient satisfaction, Mohs surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients recruited for this study must undergo Mohs resection of skin cancer of the face with negative margins at the completion of their cancer resection.
  • Patients recruited for this study must have a post cancer resection defect on the face at least 1.5 centimeters in size in the greatest dimension.
  • Patients recruited for this study must undergo single stage repair of their post cancer resection defect with primary closure or local flaps.
  • Patients must be from the Greater Vancouver area.

Exclusion Criteria:

  • Patients with insufficient visual acuity to be able to appreciate wound and scarring changes to their face post-operatively will be excluded.
  • Patients lacking the cognitive capacity to complete the data collection forms utilized in this study will be excluded.
  • Patients suffering from significant psychiatric conditions will be excluded.

Sites / Locations

  • Dermatology & Skin Science (UBC), The Skin Care Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Viewing of cancer excision defect

No viewing of cancer excision defect

Arm Description

Patients in this arm of the study will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.

Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction.

Outcomes

Primary Outcome Measures

Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be assessed on a ten point scale on the day of surgery.

Secondary Outcome Measures

Ability to recall cancer excision defect size.
Patients will be asked to draw what they recall to be the size of their cancer excision defect prior to its reconstruction. This will be done at the final routine surgical follow up appointment (3 months after surgery).
Symptomatic scarring
Patients will complete survey questions to determine whether they are bothered by their scar appearance, texture or any neuropathic symptoms.
Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be reassessed on a ten point scale at the two week and 3 month routine followup appointments.

Full Information

First Posted
July 16, 2014
Last Updated
October 2, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02230462
Brief Title
Patient Satisfaction After Facial Reconstruction
Official Title
Effects of Visualization of Pre-operative Defects on Patient Satisfaction After Facial Reconstruction for Skin Cancer Resection.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effects of visualization of skin cancer resection defects on the face on the post-operative satisfaction of patients after their reconstruction. To achieve this aim, patients invited to participate in this study will be randomized to either seeing or not seeing their skin cancer excision defect prior to reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to determine if visualization of the defect prior to reconstruction has any effect on patient satisfaction and if any detected effect has durability over time.
Detailed Description
Purpose: The purpose of this study is to assess patient satisfaction after reconstruction of Mohs skin cancer resection defects in the face, with the resection defect either seen or unseen by the patient. In this way, the investigators will determine the effects of visualization of the pre-operative defects on patient satisfaction after facial reconstruction. Any effects on patient satisfaction that are identified will then be tracked over time. Hypothesis: The null hypothesis for this study is that patient satisfaction after reconstruction of Mohs defects on the face is unaffected by the opportunity to visualize the defect prior to reconstruction, and that this observation persists over time. Furthermore, patients are able to recall the size of their cancer resection defect as accurately from a detailed description as from seeing the defect in a mirror. Justification: This study will address whether visualization of a defect prior to its reconstruction affects patient satisfaction. Visualization of a defect prior to reconstruction is not standardized and is occasionally, but by no means necessarily, a portion of their consent for the reconstruction procedure. For the excision and reconstruction procedure in this study, all patients will be receiving the gold standard treatment for skin cancer. This includes a Mohs excision of their cancer and subsequent reconstruction of the excision defect using either primary closure or local flaps. Alternative treatments to this approach include various forms of excision and reconstruction where cancer free margins cannot be immediately determined. Objectives: The objectives of this study are to determine whether visualization of a cancer excision defect on the face, prior to its reconstruction, improves post-reconstruction patient satisfaction. The satisfaction measures sought will primarily be satisfaction with the cosmetic result but will also include measures pertaining to symptomatic scarring, skin related quality of life and ability to recall defect size will also be collected. Research Method: Patients meeting research criteria will be recruited to this study. These patients will all undergo cancer excision and reconstruction of the skin cancer defect during the same clinic visit. After their cancer excision is complete, they will be and randomized to either viewing or not-viewing their skin cancer excision defect prior to its reconstruction. After reconstruction they will be provided a series of surveys that assess the research questions posed by this study. Surveys will be distributed in the clinic on the day of surgery and at routine follow-up appointments at one week and two to three months. Statistical Analysis: The planned sample size for this study is eighty patients randomized to two groups of forty. Study end points will be sought from patient answers to three sets of surveys that determine patient satisfaction with the cosmetic appearance of their reconstruction, ranked on an ordinal scale, as a primary end-point. Secondary end points using ordinal and binary measures will also be sought and include skin related quality of life (as measured by the Skindex 16), scarring, and the ability to accurately recall the size of the skin cancer excision defect. A chi-squared analysis of the data will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasms
Keywords
patient satisfaction, Mohs surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Viewing of cancer excision defect
Arm Type
Experimental
Arm Description
Patients in this arm of the study will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.
Arm Title
No viewing of cancer excision defect
Arm Type
No Intervention
Arm Description
Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction.
Intervention Type
Other
Intervention Name(s)
Viewing of cancer excision defect
Intervention Description
Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.
Primary Outcome Measure Information:
Title
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
Description
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be assessed on a ten point scale on the day of surgery.
Time Frame
The day of reconstruction.
Secondary Outcome Measure Information:
Title
Ability to recall cancer excision defect size.
Description
Patients will be asked to draw what they recall to be the size of their cancer excision defect prior to its reconstruction. This will be done at the final routine surgical follow up appointment (3 months after surgery).
Time Frame
3 months after reconstruction
Title
Symptomatic scarring
Description
Patients will complete survey questions to determine whether they are bothered by their scar appearance, texture or any neuropathic symptoms.
Time Frame
3 months after reconstruction
Title
Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
Description
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be reassessed on a ten point scale at the two week and 3 month routine followup appointments.
Time Frame
2 weeks, and 3 months after reconstruction.
Other Pre-specified Outcome Measures:
Title
Skindex -16
Description
Patient quality of life relating to their skin cancer will be assessed using the Skindex-16 (a validated tool for this purpose).
Time Frame
The day of reconstruction, 2 weeks, and 3 months after reconstruction.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients recruited for this study must undergo Mohs resection of skin cancer of the face with negative margins at the completion of their cancer resection. Patients recruited for this study must have a post cancer resection defect on the face at least 1.5 centimeters in size in the greatest dimension. Patients recruited for this study must undergo single stage repair of their post cancer resection defect with primary closure or local flaps. Patients must be from the Greater Vancouver area. Exclusion Criteria: Patients with insufficient visual acuity to be able to appreciate wound and scarring changes to their face post-operatively will be excluded. Patients lacking the cognitive capacity to complete the data collection forms utilized in this study will be excluded. Patients suffering from significant psychiatric conditions will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryce J Cowan, MD, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology & Skin Science (UBC), The Skin Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryce J Cowan, MD, PhD
Phone
604-875-4888
Email
skinsurg@gmail.com
First Name & Middle Initial & Last Name & Degree
Jorga Zabojova, MD, PhD
Email
jorga.zabojova@gmail.com
First Name & Middle Initial & Last Name & Degree
Bryce J Cowan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jorga Zabojova, MD, PhD

12. IPD Sharing Statement

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Patient Satisfaction After Facial Reconstruction

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