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

NCT02373722 | Completed

• 4 other identifiers: IRB00028840NCI-2015-00217CCCWFU 01714P30CA012197
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Skin Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient satisfaction score

  Up to 1 week after completion of study

• Mobility adherence as measured by Fitbit monitor

  Up to 1 week after completion of study

• Incidence of adverse events

  Up to 1 week after completion of study

Study Arms (4)

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.

Procedure: Mohs Surgery; Other: Internet-Based Intervention; Behavioral: Telephone-Based Intervention; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Questionnaire Administration; Other: Survey Administration

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

Procedure: Mohs Surgery; Other: Internet-Based Intervention; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Questionnaire Administration; Other: Survey Administration

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.

Procedure: Mohs Surgery; Behavioral: Telephone-Based Intervention; Behavioral: Exercise Intervention; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Questionnaire Administration; Other: Survey Administration

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.

Procedure: Mohs Surgery; Behavioral: Exercise Intervention; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Mohs Surgery PROCEDURE

Undergo Mohs surgery

Group I (video, text message); Group II (educational video); Group III (text message); Group IV (control)

Internet-Based Intervention OTHER

Watch website application based educational video

Group I (video, text message); Group II (educational video)

Telephone-Based Intervention BEHAVIORAL

Receive text messages

Group I (video, text message); Group III (text message)

Educational Intervention OTHER

Watch website application based educational video

Also known as: Education for Intervention, Intervention, Educational

Group I (video, text message); Group II (educational video)

Exercise Intervention BEHAVIORAL

Use Fitbit

Group I (video, text message); Group II (educational video); Group III (text message); Group IV (control)

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment OTHER

Applied to the wound area

Also known as: Aquaphor

Group I (video, text message); Group II (educational video); Group III (text message); Group IV (control)

Questionnaire Administration OTHER

Ancillary studies

Group I (video, text message); Group II (educational video); Group III (text message); Group IV (control)

Survey Administration OTHER

Ancillary studies

Group I (video, text message); Group II (educational video); Group III (text message); Group IV (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Mohs Surgery; Early Intervention, Educational; Educational Status; Methods; Petrolatum

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microsurgery; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Hydrocarbons; Organic Chemicals

Study Officials

• Daniel Pearce

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

US (1)