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

Primary Purpose

Malignant Skin Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mohs Surgery
Internet-Based Intervention
Telephone-Based Intervention
Educational Intervention
Exercise Intervention
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Questionnaire Administration
Survey Administration
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Skin Neoplasm

Eligibility Criteria

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

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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group I (video, text message)

Group II (educational video)

Group III (text message)

Group IV (control)

Arm Description

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.

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

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Medication adherence
The mean number of times the medication was applied will be compared for the three intervention groups versus the control group.

Secondary Outcome Measures

Patient satisfaction score
Patient satisfaction scores across the four randomization groups will be compared using analysis of variance (ANOVA) methods.
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.
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.

Full Information

First Posted
February 23, 2015
Last Updated
June 29, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02373722
Brief Title
Website Application Based Education and Text Messaging in Improving Skin Wound Care in Patients Undergoing Mohs Surgery
Official Title
Web App Based Patient Education in Mohs Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Skin Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (video, text message)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (educational video)
Arm Type
Experimental
Arm Description
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
Arm Title
Group III (text message)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group IV (control)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mohs Surgery
Intervention Description
Undergo Mohs surgery
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Watch website application based educational video
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive text messages
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Watch website application based educational video
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Use Fitbit
Intervention Type
Other
Intervention Name(s)
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Other Intervention Name(s)
Aquaphor
Intervention Description
Applied to the wound area
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Preoperative anxiety score
Description
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.
Time Frame
Before surgery
Title
Patient knowledge score
Description
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.
Time Frame
Up to 1 week after completion of study
Title
Medication adherence
Description
The mean number of times the medication was applied will be compared for the three intervention groups versus the control group.
Time Frame
Up to 1 week after completion of study
Secondary Outcome Measure Information:
Title
Patient satisfaction score
Description
Patient satisfaction scores across the four randomization groups will be compared using analysis of variance (ANOVA) methods.
Time Frame
Up to 1 week after completion of study
Title
Mobility adherence as measured by Fitbit monitor
Description
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.
Time Frame
Up to 1 week after completion of study
Title
Incidence of adverse events
Description
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.
Time Frame
Up to 1 week after completion of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pearce
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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