Skin NeoplasmsNCT02230462
Patient Satisfaction After Facial Reconstruction
A study testing Viewing of cancer excision defect in people with Skin Neoplasms, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Neoplasms
- What is being tested?
- Viewing of cancer excision defect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dermatology & Skin Science (UBC), The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
Bryce J Cowan, MD, PhD, 604-875-4888, skinsurg@gmail.com
Jorga Zabojova, MD, PhD, jorga.zabojova@gmail.com
About this study
Official title: Effects of Visualization of Pre-operative Defects on Patient Satisfaction After Facial Reconstruction for Skin Cancer Resection.
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.
Read the 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.
- Conditions
- Skin Neoplasms
- Being tested
- Viewing of cancer excision defect
- Keywords
- patient satisfaction, Mohs surgery
- Medical subject headings
- Skin Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viewing of cancer excision defectOther
Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Viewing of cancer excision defect | Experimental | 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. Receives: Other: Viewing of cancer excision defect |
| No viewing of cancer excision defect | No intervention | Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The day of reconstruction.
Secondary outcomes (3)
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).
Measured: 3 months after reconstruction
Symptomatic scarring
Patients will complete survey questions to determine whether they are bothered by their scar appearance, texture or any neuropathic symptoms.
Measured: 3 months after reconstruction
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.
Measured: 2 weeks, and 3 months after reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryce J Cowan, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230462
- Sponsor's protocol ID
- H13-02922
- Status last verified
- Oct 2014
- First submitted
- 16 Jul 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visualization of Pre-operative Defects on Patient Satisfaction After Facial Reconstruction for Skin Cancer Resection.
- ClinicalTrials.gov ID
- NCT02230462
- Acronym / sponsor ID
- H13-02922
- Conditions
- Skin Neoplasms
- Keywords
- patient satisfaction, Mohs surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 3 Sep 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viewing of cancer excision defect | Experimental | Other: Viewing of cancer excision defectPatients 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. |
| No viewing of cancer excision defect | No intervention | –Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Viewing of cancer excision defectPatients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction. | Other | Viewing of cancer excision defect |
Primary outcome
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
Time frame: The day of 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.
3 secondary outcomes
Ability to recall cancer excision defect size.
Time frame: 3 months after reconstruction
Symptomatic scarring
Time frame: 3 months after reconstruction
Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
Time frame: 2 weeks, and 3 months after reconstruction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
Related trials for Skin Neoplasms
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Dermatology & Skin Science (UBC), The Skin Care Centre
Vancouver, Canada
Bryce J Cowan, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viewing of cancer excision defect in people with Skin Neoplasms, run by University of British Columbia at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction. (time frame: The day of reconstruction.). 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 Oct 2014.