Malignant Skin Neoplasm
Conditions
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.
Interventions
BEHAVIORALTelephone-Based Intervention
Receive text messages
PROCEDUREMohs Surgery
Undergo Mohs surgery
OTHERInternet-Based Intervention
Watch website application based educational video
OTHEREducational Intervention
Watch website application based educational video
BEHAVIORALExercise Intervention
Use Fitbit
Applied to the wound area
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative anxiety score | Before surgery | 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 | Up to 1 week after completion of study | 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 | Up to 1 week after completion of study | The mean number of times the medication was applied will be compared for the three intervention groups versus the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | Up to 1 week after completion of study | Patient satisfaction scores across the four randomization groups will be compared using analysis of variance (ANOVA) methods. |
| Mobility adherence as measured by Fitbit monitor | Up to 1 week after completion of study | 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 | Up to 1 week after completion of study | 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. |
Countries
United States
Outcome results
None listed