TelemedicineNCT05712668
Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors
A study testing Preoperative counseling and Asynchronous telemedicine in people with Telemedicine and Counseling, run by Carilion Clinic at 1 site in United States.
Trial summary
To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Telemedicine, Counseling
- What is being tested?
- Preoperative counseling and Asynchronous telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to May 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with clinical stage I histologically confirmed endometrial carcinoma, which is clinically confined to the uterus and comprises approximately two-thirds of all endometrial carcinoma cases
- Patients undergoing planned minimally invasive surgical procedures, such as a minimally invasive technique such as conventional laparoscopy or robotic-assisted laparoscopy, as part of treatment at the Division of Gynecologic Oncology at Carilion Clinic, Roanoke, VA
- Internet/cellular access at home
- Ability to read and comprehend materials on questionnaires
Who cannot join
- 1 Patients that do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Caroline Kim contact
United States1 site, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24016
Shannon D Armbruster, MD, MPH
David A Iglesias, MD, MS
About this study
Official title: A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.
Read the detailed description
Newly diagnosed endometrial cancer survivors, who are presenting for their initial consultation with a plan for minimally invasive surgery, will be randomized 1:1 to standard counseling or standard counseling plus asynchronous telemedicine video. The asynchronous video will be available outside of the office and can be viewed multiple times. The primary endpoint is patient anxiety, measured via the State-Trait Anxiety Inventory (STAI) questionnaire, assessed before surgery. The secondary outcomes of anxiety following surgery as well as patient satisfaction with counseling type (measured via the Patient Satisfaction Questionnaire (PSQ-18)) before and after surgery will be compared between groups. Both groups will complete questionnaires following their initial consultation (but before surgery) and at their post-operative visit. For the telemedicine group, the duration and frequency of video views will be collected. Participants completing both surveys will receive a survivorship gift bag.
- Conditions
- Telemedicine, Counseling
- Being tested
- Preoperative counseling, Asynchronous telemedicine
- Keywords
- Telemedicine, Preoperative Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative counselingBehavioural
Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
Asynchronous telemedicineBehavioural
Also called Mytonomy
An asynchronous video will be delivered by Mytonomy. This platform allows investigators to track user analytics relating to the time, frequency, or duration watched by the user.
| Study group | Role | What they receive |
|---|---|---|
| Standard Pre-operative Counseling | Active comparator | Participants will receive standard counseling. Receives: Behavioral: Preoperative counseling |
| Standard Pre-operative Counseling plus Asynchronous Telemedicine | Experimental | Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling. Receives: Behavioral: Preoperative counseling; Behavioral: Asynchronous telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety related to preoperative counseling
It will be measured via the State-Trait Anxiety Inventory (STAI) questionnaire, a validated tool used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. STAI is comprised of 20 concise questions on a 4-point Likert scale.
Measured: Following the initial office visit or online viewing session, prior to surgery
Secondary outcomes (3)
Patient satisfaction with preoperative counseling
It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire. It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction.
Measured: Following the initial office visit or online viewing session, prior to surgery
Patient satisfaction with preoperative counseling, surgical impact
It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire. It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction.
Measured: At the postoperative exam, approximately 2-4 weeks from surgery
Anxiety related to preoperative counseling, surgical impact
It will be measured via the State-Trait Anxiety Inventory (STAI) questionnaire, a validated tool used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. STAI is comprised of 20 concise questions on a 4-point Likert scale.
Measured: At the postoperative exam, approximately 2-4 weeks from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start9 May 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Model description
- A total of 100 patients will be enrolled and randomized if they meet the inclusion criteria. Fifty patients allocated will be allocated to receive pre-operative counseling via standard face-to-face care and 50 patients allocated to receive standard pre-operative counseling with the addition of asynchronous telemedicine.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Shannon Armbruster, Carilion Clinic
- Investigators
- Shannon Armbruster, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712668
- Sponsor's protocol ID
- IRB 21-1305
- Status last verified
- Mar 2024
- First submitted
- 2 Jan 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05712668
- Acronym / sponsor ID
- IRB 21-1305
- Conditions
- Telemedicine, Counseling
- Keywords
- Telemedicine, Preoperative Counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 9 May 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 3 Feb 2023 (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.
To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.
Detailed description
Newly diagnosed endometrial cancer survivors, who are presenting for their initial consultation with a plan for minimally invasive surgery, will be randomized 1:1 to standard counseling or standard counseling plus asynchronous telemedicine video. The asynchronous video will be available outside of the office and can be viewed multiple times. The primary endpoint is patient anxiety, measured via the State-Trait Anxiety Inventory (STAI) questionnaire, assessed before surgery. The secondary outcomes of anxiety following surgery as well as patient satisfaction with counseling type (measured via the Patient Satisfaction Questionnaire (PSQ-18)) before and after surgery will be compared between groups. Both groups will complete questionnaires following their initial consultation (but before surgery) and at their post-operative visit. For the telemedicine group, the duration and frequency of video views will be collected. Participants completing both surveys will receive a survivorship gift bag.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 100 patients will be enrolled and randomized if they meet the inclusion criteria. Fifty patients allocated will be allocated to receive pre-operative counseling via standard face-to-face care and 50 patients allocated to receive standard pre-operative counseling with the addition of asynchronous telemedicine.
| Arm | Type | Receives |
|---|---|---|
| Standard Pre-operative Counseling | Active comparator | Behavioral: Preoperative counselingParticipants will receive standard counseling. |
| Standard Pre-operative Counseling plus Asynchronous Telemedicine | Experimental | Behavioral: Preoperative counseling, Behavioral: Asynchronous telemedicineParticipants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical stage I histologically confirmed endometrial carcinoma, which is clinically confined to the uterus and comprises approximately two-thirds of all endometrial carcinoma cases
- Patients undergoing planned minimally invasive surgical procedures, such as a minimally invasive technique such as conventional laparoscopy or robotic-assisted laparoscopy, as part of treatment at the Division of Gynecologic Oncology at Carilion Clinic, Roanoke, VA
- Internet/cellular access at home
- Ability to read and comprehend materials on questionnaires
Key exclusion criteria (1 listed)
- 1 Patients that do not meet the inclusion criteria
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 |
|---|---|---|
| Preoperative counselingProviders will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care. | Behavioural | Standard Pre-operative Counseling, Standard Pre-operative Counseling plus Asynchronous Telemedicine |
| Asynchronous telemedicineAlso: MytonomyAn asynchronous video will be delivered by Mytonomy. This platform allows investigators to track user analytics relating to the time, frequency, or duration watched by the user. | Behavioural | Standard Pre-operative Counseling plus Asynchronous Telemedicine |
Primary outcome
Anxiety related to preoperative counseling
Time frame: Following the initial office visit or online viewing session, prior to surgery
It will be measured via the State-Trait Anxiety Inventory (STAI) questionnaire, a validated tool used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. STAI is comprised of 20 concise questions on a 4-point Likert scale.
3 secondary outcomes
Patient satisfaction with preoperative counseling
Time frame: Following the initial office visit or online viewing session, prior to surgery
Patient satisfaction with preoperative counseling, surgical impact
Time frame: At the postoperative exam, approximately 2-4 weeks from surgery
Anxiety related to preoperative counseling, surgical impact
Time frame: At the postoperative exam, approximately 2-4 weeks from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Caroline Kim contact
Shannon Armbruster, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative counseling and Asynchronous telemedicine in people with Telemedicine and Counseling, run by Carilion Clinic 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 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Armbruster, MD ((540) 581-0275, sdarmbruster@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety related to preoperative counseling (time frame: Following the initial office visit or online viewing session, prior to surgery). 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 12 Mar 2024.