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Malignant Skin NeoplasmNCT02373722

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

A study testing Mohs Surgery, Internet-Based Intervention and Telephone-Based Intervention in people with Malignant Skin Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Skin Neoplasm
What is being tested?
Mohs Surgery, Internet-Based Intervention and Telephone-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
Mar 2015to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To create a web application which will educate dermatologic surgery patients prior to their operations with educational videos.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Mohs Surgery, Internet-Based Intervention, Telephone-Based Intervention, Educational Intervention, Exercise Intervention
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mohs SurgeryProcedure or surgery

    Undergo Mohs surgery

  • Internet-Based InterventionOther

    Watch website application based educational video

  • Telephone-Based InterventionBehavioural

    Receive text messages

  • Educational InterventionOther

    Also called Education for Intervention, Intervention, Educational

    Watch website application based educational video

  • Exercise InterventionBehavioural

    Use Fitbit

  • Petrolatum-Mineral Oil-Lanolin-Ceresin OintmentOther

    Also called Aquaphor

    Applied to the wound area

  • Questionnaire AdministrationOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT02373722
Study groupRoleWhat they receive
Group I (video, text message)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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
Receives: 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)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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.
Receives: Procedure: Mohs Surgery; Behavioral: Exercise Intervention; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Questionnaire Administration; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before surgery

  2. 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.

    Measured: Up to 1 week after completion of study

  3. Medication adherence

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

    Measured: Up to 1 week after completion of study

Secondary outcomes (3)

  1. Patient satisfaction score

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

    Measured: Up to 1 week after completion of study

  2. 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.

    Measured: Up to 1 week after completion of study

  3. 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.

    Measured: Up to 1 week after completion of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02373722
Sponsor's protocol ID
IRB00028840
Other IDs
NCI-2015-00217, CCCWFU 01714, P30CA012197
Status last verified
Jun 2018
First submitted
23 Feb 2015
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mohs Surgery, Internet-Based Intervention and Telephone-Based Intervention in people with Malignant Skin Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative anxiety score (time frame: Before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02373722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.

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