Keratinocyte CarcinomaNCT04377971
Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen
A study testing SOC education, Ask-tell-ask education and Participant satisfaction survey in people with Keratinocyte Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine a different way to educate patients about taking care of their wound and see how this method affects patient satisfaction, compliance to the wound care regimen, and patient experience. The teach-back method is delivered using the ask-tell-ask method. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Keratinocyte Carcinoma
- What is being tested?
- SOC education, Ask-tell-ask education and Participant satisfaction survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 5 Jul 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to outpatient Mohs clinic at University Department of Dermatology, Two Chagrin Highlands for the first time
- Have excision(s) from Mohs Micrographic Surgery on the lower extremities that are left to heal by secondary intention
- English-speaking
Who cannot join
- Non-English speaking
- A clinical diagnosis of mental, learning, and visual disabilities
- A clinical diagnosis of dementia
- Those who have received Mohs Micrographic Surgery before regardless of area
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: The Effectiveness of the Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen After Mohs Micrographic Surgery: A Pilot Study
The purpose of this study is to examine a different way to educate patients about taking care of their wound and see how this method affects patient satisfaction, compliance to the wound care regimen, and patient experience.
The teach-back method is delivered using the ask-tell-ask method. Investigators will ask the patient about their knowledge of wound care healing, provide the patient educational component, then ask the patient to repeat what was said. If the answer is wrong or incomplete, the researcher will go over the information again with the patient to clear up any misunderstandings.
Read the detailed description
Patients undergoing Mohs Micrographic surgery for skin cancers on the lower extremities for the first time that are left to heal by secondary intention are randomized either to receive a scripted teach-back session or a standard of care wound care education. This study wishes to compare wound care adherence, patient experience, wound complications, and the number of phone calls made by patients to the office between the two cohorts
primary objective is to determine whether study participants who have received the teach-back method have an increase wound care adherence at one week post-operatively, compared to those who received the standard of care.
To characterize differences in the patient experience between the two interventional groups 2 weeks after surgery.
To determine whether the number of phone calls made post-operatively by patients will decrease in a 2 week follow-up time period.
To characterize the differences in patient wound care adherence at 2 weeks after surgery.
To determine whether there is a difference in complication incidence post-operatively
- Conditions
- Keratinocyte Carcinoma
- Being tested
- SOC education, Ask-tell-ask education, Participant satisfaction survey, Wound care adherence survey
- Keywords
- Mohs Micrographic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC educationBehavioural
Standard participant education from researcher
Ask-tell-ask educationBehavioural
Participant education using the ask-tell-ask method. First the researcher will ask a question about participant understanding of wound care and after hearing the participant's answer, the researcher will then proceed to tell the patient how to best take care of their wound using a standardized script. After the educational portion, the researcher will then ask the patient to repeat the information that was shared. If the participant's answer is wrong or incomplete, the researcher will then explain the instructions again to ensure that the participant understands the steps needed.
Participant satisfaction surveyOther
Participant satisfaction survey using components of the 16 item Skindex questionnaire and the 18 item version Patient Satisfaction Survey, adapted for treatment of skin cancer to characterize patient experience administered at two weeks post-operatively in person
Wound care adherence surveyOther
Wound care adherence survey administered at one week over the phone and at two weeks in person
| Study group | Role | What they receive |
|---|---|---|
| Ask-tell-ask method | Experimental | Study team will provide participant education using the ask-tell-ask method. Participants will receive a post-operative instruction sheet containing detailed information regarding wound care for reference and will receive a phone call at 1 week to inquire about wound care adherence. Participants will come to clinic at 2 weeks to have wounds assessed in addition to answering surveys regarding wound care adherence and participant experience. Receives: Behavioral: Ask-tell-ask education; Other: Participant satisfaction survey; Other: Wound care adherence survey |
| Standard of Care (SOC) | Active comparator | Participants will receive SOC education from the researcher. Participants will receive a post-operative instruction sheet containing detailed information regarding wound care for reference and will receive a phone call at 1 week to inquire about wound care adherence. Participants will come to clinic at 2 weeks to have wounds assessed in addition to answering surveys regarding wound care adherence and participant experience. Receives: Behavioral: SOC education; Other: Participant satisfaction survey; Other: Wound care adherence survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound care adherence as measured by wound care adherence survey
Wound care adherence as measured by a wound care adherence survey with scale values ranging from 3-15, with a higher score indicating greater compliance
Independent two-sample two-sided t-tests to compare wound care adherence scores between the intervention group (receiving the "teach-back method") and the control group (receiving the standard of care).
Measured: 1 week
Secondary outcomes (4)
Patient experience as measured by participant satisfaction survey
Patient experience as measured by participant satisfaction survey, which uses components of the 16 item Skindex questionnaire and the 18 item version Patient Satisfaction Survey, adapted for treatment of skin cancer to characterize patient experience. The survey scale ranges from 4-20, with a higher score indicating a greater patient experience.
Measured: At 2 weeks
Number of phone calls made post-operatively by participants
Number of phone calls made post-operatively by participants
Measured: At 2 weeks
Complication incidence post-operatively
Complication incidence post-operatively
Measured: At 2 weeks
Wound care adherence as measured by wound care adherence survey
Wound care adherence as measured by a wound care adherence survey with scale values ranging from 3-15, with higher scores indicating greater compliance.
Independent two-sample two-sided t-tests to compare wound care adherence scores between the intervention group (receiving the "teach-back method") and the control group (receiving the standard of care)
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start9 Nov 2020
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratinocyte CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Wong, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377971
- Sponsor's protocol ID
- CASE1620
- Status last verified
- Apr 2025
- First submitted
- 4 May 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD in order to protect the identity of the research participants
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Teach-back Method on Patient Satisfaction and Adherence to Wound Care Regimen After Mohs Micrographic Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT04377971
- Acronym / sponsor ID
- CASE1620
- Conditions
- Keratinocyte Carcinoma
- Keywords
- Mohs Micrographic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine a different way to educate patients about taking care of their wound and see how this method affects patient satisfaction, compliance to the wound care regimen, and patient experience.
The teach-back method is delivered using the ask-tell-ask method. Investigators will ask the patient about their knowledge of wound care healing, provide the patient educational component, then ask the patient to repeat what was said. If the answer is wrong or incomplete, the researcher will go over the information again with the patient to clear up any misunderstandings.
Detailed description
Patients undergoing Mohs Micrographic surgery for skin cancers on the lower extremities for the first time that are left to heal by secondary intention are randomized either to receive a scripted teach-back session or a standard of care wound care education. This study wishes to compare wound care adherence, patient experience, wound complications, and the number of phone calls made by patients to the office between the two cohorts
primary objective is to determine whether study participants who have received the teach-back method have an increase wound care adherence at one week post-operatively, compared to those who received the standard of care.
To characterize differences in the patient experience between the two interventional groups 2 weeks after surgery.
To determine whether the number of phone calls made post-operatively by patients will decrease in a 2 week follow-up time period.
To characterize the differences in patient wound care adherence at 2 weeks after surgery.
To determine whether there is a difference in complication incidence post-operatively
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ask-tell-ask method | Experimental | Behavioral: Ask-tell-ask education, Other: Participant satisfaction survey, Other: Wound care adherence surveyStudy team will provide participant education using the ask-tell-ask method. Participants will receive a post-operative instruction sheet containing detailed information regarding wound care for reference and will receive a phone call at 1 week to inquire about wound care adherence. Participants will come to clinic at 2 weeks to have wounds assessed in addition to answering surveys regarding wound care adherence and participant experience. |
| Standard of Care (SOC) | Active comparator | Behavioral: SOC education, Other: Participant satisfaction survey, Other: Wound care adherence surveyParticipants will receive SOC education from the researcher. Participants will receive a post-operative instruction sheet containing detailed information regarding wound care for reference and will receive a phone call at 1 week to inquire about wound care adherence. Participants will come to clinic at 2 weeks to have wounds assessed in addition to answering surveys regarding wound care adherence and participant experience. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting to outpatient Mohs clinic at University Department of Dermatology, Two Chagrin Highlands for the first time
- Have excision(s) from Mohs Micrographic Surgery on the lower extremities that are left to heal by secondary intention
- English-speaking
Key exclusion criteria (4 listed)
- Non-English speaking
- A clinical diagnosis of mental, learning, and visual disabilities
- A clinical diagnosis of dementia
- Those who have received Mohs Micrographic Surgery before regardless of area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOC educationStandard participant education from researcher | Behavioural | Standard of Care (SOC) |
| Ask-tell-ask educationParticipant education using the ask-tell-ask method. First the researcher will ask a question about participant understanding of wound care and after hearing the participant's answer, the researcher will then proceed to tell the patient how to best take care of their wound using a standardized script. After the educational portion, the researcher will then ask the patient to repeat the information that was shared. If the participant's answer is wrong or incomplete, the researcher will then explain the instructions again to ensure that the participant understands the steps needed. | Behavioural | Ask-tell-ask method |
| Participant satisfaction surveyParticipant satisfaction survey using components of the 16 item Skindex questionnaire and the 18 item version Patient Satisfaction Survey, adapted for treatment of skin cancer to characterize patient experience administered at two weeks post-operatively in person | Other | Ask-tell-ask method, Standard of Care (SOC) |
| Wound care adherence surveyWound care adherence survey administered at one week over the phone and at two weeks in person | Other | Ask-tell-ask method, Standard of Care (SOC) |
Primary outcome
Wound care adherence as measured by wound care adherence survey
Time frame: 1 week
Wound care adherence as measured by a wound care adherence survey with scale values ranging from 3-15, with a higher score indicating greater compliance Independent two-sample two-sided t-tests to compare wound care adherence scores between the intervention group (receiving the "teach-back method") and the control group (receiving the standard of care).
4 secondary outcomes
Patient experience as measured by participant satisfaction survey
Time frame: At 2 weeks
Number of phone calls made post-operatively by participants
Time frame: At 2 weeks
Complication incidence post-operatively
Time frame: At 2 weeks
Wound care adherence as measured by wound care adherence survey
Time frame: At 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No. We will not share IPD in order to protect the identity of the research participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Wong, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC education, Ask-tell-ask education and Participant satisfaction survey in people with Keratinocyte Carcinoma, run by Case Comprehensive Cancer Center 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 3 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 2 May 2025. 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?
Wound care adherence as measured by wound care adherence survey (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.