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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00217 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 01714 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies how well website application (web app) based education and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a surgical procedure used to treat skin cancer). Website application and text messaging based education may help patients stick to wound care instructions before and after surgery, lower anxiety level, and may help monitor their activity.
PRIMARY OBJECTIVES:
I. To create a web application which will educate dermatologic surgery patients prior to their operations with educational videos.
SECONDARY OBJECTIVES:
I. To create and evaluate a web based system to send wound care instructions to patients by text message after their operation.
II. Qualitative comments from participants and research staff concerning the feasibility of this approach and the use of Fitbit activity trackers as a means to monitor movement restriction.
III. The rate of adverse events.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP I: Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly twice daily (BID) to the wound area.
GROUP II: Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area.
GROUP III: Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.
GROUP IV: Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.
After completion of study, patients are followed up at 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (video, text message) | Experimental | Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area. |
|
| Group II (educational video) | Experimental | Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area |
|
| Group III (text message) | Experimental | Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mohs Surgery | Procedure | Undergo Mohs surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative anxiety score | The preoperative anxiety scores of patients randomized to receive or not receive the educational video will be compared using a t-test or appropriate non-parametric test (Wilcoxon Rank Sum or Sign test) based on the distribution of the scores. | Before surgery |
| Patient knowledge score | Patient knowledge scores of patients randomized to receive or not receive the educational video will be compared using a t-test or appropriate non-parametric test (Wilcoxon Rank Sum or Sign test) based on the distribution of the scores. | Up to 1 week after completion of study |
| Medication adherence | The mean number of times the medication was applied will be compared for the three intervention groups versus the control group. | Up to 1 week after completion of study |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction score | Patient satisfaction scores across the four randomization groups will be compared using analysis of variance (ANOVA) methods. | Up to 1 week after completion of study |
| Mobility adherence as measured by Fitbit monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Pearce | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| Group IV (control) | Experimental | Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area. |
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| Internet-Based Intervention | Other | Watch website application based educational video |
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| Telephone-Based Intervention | Behavioral | Receive text messages |
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| Educational Intervention | Other | Watch website application based educational video |
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| Exercise Intervention | Behavioral | Use Fitbit |
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| Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment | Other | Applied to the wound area |
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| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
|
Compare the average number of steps taken each day between groups and the cumulative number of steps taken over the whole week using ANOVA methods. Percentage of patients with average daily activity below 2500 steps will be compared using the Chi-Squared or Fisher's Exact test. All three intervention groups will be compared to the control group.
| Up to 1 week after completion of study |
| Incidence of adverse events | The proportion of patients reporting adverse events will be compared using chi-squared tests or Fisher's exact tests, depending on the expected frequency of events. Comparisons will be made for those given versus not given the surgery education mobile app and then for those given versus not given text messages. To look at all four groups independently, a global statistic will be initially calculated. If significant, comparisons between the four groups will be made. | Up to 1 week after completion of study |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015580 | Mohs Surgery |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D008866 | Microsurgery |
| D013514 | Surgical Procedures, Operative |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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