Website Application Based Education and Text Messaging in Improving Skin Wound Care in Patients Undergoing Mohs Surgery

Web App Based Patient Education in Mohs Surgery

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.

Study Overview

• Status: Completed
• Conditions: Malignant Skin Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Procedure: Mohs Surgery; Other: Internet-Based Intervention; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient is undergoing Mohs surgery
• Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
• The subject is able to complete the study and comply with study instructions, including attending all study visits
• The patient has a cell phone capable of receiving text messages

Exclusion Criteria:

• The patient is not indicated for Mohs surgery
• Inability to complete all study-related visits
• Non-English speaking patients
• The patient cannot receive text messages

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (video, text message); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive text messages; Procedure: Mohs Surgery; Undergo Mohs surgery; Other: Internet-Based Intervention; Watch website application based educational video; Other: Educational Intervention; Watch website application based educational video; Other Names: Education for Intervention; Intervention, Educational; Behavioral: Exercise Intervention; Use Fitbit; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Applied to the wound area; Other Names: Aquaphor
Experimental: Group II (educational video); 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	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Procedure: Mohs Surgery; Undergo Mohs surgery; Other: Internet-Based Intervention; Watch website application based educational video; Other: Educational Intervention; Watch website application based educational video; Other Names: Education for Intervention; Intervention, Educational; Behavioral: Exercise Intervention; Use Fitbit; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Applied to the wound area; Other Names: Aquaphor
Experimental: Group III (text message); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive text messages; Procedure: Mohs Surgery; Undergo Mohs surgery; Behavioral: Exercise Intervention; Use Fitbit; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Applied to the wound area; Other Names: Aquaphor
Experimental: Group IV (control); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Procedure: Mohs Surgery; Undergo Mohs surgery; Behavioral: Exercise Intervention; Use Fitbit; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Applied to the wound area; Other Names: Aquaphor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Daniel Pearce, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms; Dermatologic Agents; Emollients; Petrolatum; Mineral Oil
• Other Study ID Numbers: IRB00028840; P30CA012197 (U.S. NIH Grant/Contract); NCI-2015-00217 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 01714 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No