Overview

This trial is active, not recruiting.

Condition malignant skin neoplasm
Treatments mohs surgery, internet-based intervention, telephone-based intervention, educational intervention, exercise intervention, petrolatum-mineral oil-lanolin-ceresin ointment, questionnaire administration, survey administration
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date March 2015
End date March 2016
Trial size 90 participants
Trial identifier NCT02373722, CCCWFU 01714, NCI-2015-00217, P30CA012197

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(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.
mohs surgery
Undergo Mohs surgery
internet-based intervention
Watch website application based educational video
telephone-based intervention
Receive text messages
educational intervention Education for Intervention
Watch website application based educational video
exercise intervention
Use Fitbit
petrolatum-mineral oil-lanolin-ceresin ointment Aquaphor
Applied to the wound area
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
(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
mohs surgery
Undergo Mohs surgery
internet-based intervention
Watch website application based educational video
educational intervention Education for Intervention
Watch website application based educational video
exercise intervention
Use Fitbit
petrolatum-mineral oil-lanolin-ceresin ointment Aquaphor
Applied to the wound area
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
(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.
mohs surgery
Undergo Mohs surgery
telephone-based intervention
Receive text messages
exercise intervention
Use Fitbit
petrolatum-mineral oil-lanolin-ceresin ointment Aquaphor
Applied to the wound area
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
(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.
mohs surgery
Undergo Mohs surgery
exercise intervention
Use Fitbit
petrolatum-mineral oil-lanolin-ceresin ointment Aquaphor
Applied to the wound area
questionnaire administration
Ancillary studies
survey administration
Ancillary studies

Primary Outcomes

Measure
Preoperative anxiety score
time frame: Before surgery
Patient knowledge score
time frame: Up to 1 week after completion of study
Medication adherence
time frame: Up to 1 week after completion of study

Secondary Outcomes

Measure
Patient satisfaction score
time frame: Up to 1 week after completion of study
Mobility adherence as measured by Fitbit monitor
time frame: Up to 1 week after completion of study
Incidence of adverse events
time frame: Up to 1 week after completion of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Web App Based Patient Education in Mohs Surgery
Principal investigator Daniel Pearce
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in September 2016.