Uterine CancerNCT03583736
Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Uterine Cancer
A study testing Virtual visit and Office visit in people with Uterine Cancer, run by Case Comprehensive Cancer Center.
Trial summary
This project aims to evaluate whether rapid first contact with the oncologist the same day or the next day after pathologic diagnosis contributes to a decreased time to treatment, decreased patient anxiety and increased patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cancer
- What is being tested?
- Virtual visit and Office visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2018to 1 Jun 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uterine cancer diagnosis on biopsy read by Cleveland Clinic Pathology Department
- Patients must be willing to participate in a virtual visit as the initial meeting with an oncologist at the Cleveland Clinic.
- Receive care at Fairview Hospital, Hillcrest Hospital or Cleveland Clinic Main Campus
- Internet connected smartphone or internet connected computer with webcam
- Participants must have email access
- English speaking
- Competent to make clinic decisions
Who cannot join
- No diagnosis of uterine cancer
About this study
Official title: Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Patients With Uterine Cancer
This project aims to evaluate whether rapid first contact with the oncologist the same day or the next day after pathologic diagnosis contributes to a decreased time to treatment, decreased patient anxiety and increased patient satisfaction.
Read the detailed description
Time to treatment (time from disease diagnosis to initiation of treatment) impacts outcomes in uterine cancer. When controlled for stage, patients with longer time to treatment tend to have less favorable outcomes. Similarly, longer time to treatment has a negative impact on patients' quality of life and markers for anxiety. Our experience at this institution suggests that the time to referral (time from uterine cancer diagnosis and the patients' first encounter with the oncologist) is variable and presents the greatest opportunity for decreasing time to treatment. Among the factors that contribute to the time to referral are the time taken by the referring provider to relay the diagnosis to the patient, time taken to schedule an appointment with the specialist, and the patient's availability to keep an appointment.
Virtual visits provide an opportunity to expedite consultation with the treating oncologist by removing some of the barriers that delay face-to-face visits. Among these barriers are patients' availability for a short notice face-to-face visit based on their work or family obligations, access to transportation, and mental preparedness.
- Conditions
- Uterine Cancer
- Being tested
- Virtual visit, Office visit
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual visitBehavioural
Virtual visit with oncologist following uterine cancer diagnosis prior to scheduled office visit.
Office visitBehavioural
Scheduled office visit with oncologist following uterine cancer diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Rapid first contact virtual visit | Active comparator | Subjects will accept the offer of a virtual visit after being contacted by the nurse to offer a virtual visit with the oncologist prior to the in person office visit once a diagnosis has been confirmed. Subjects will be randomized after accepting offer of a virtual visit. Receives: Behavioral: Virtual visit |
| First contact in person office visit | Placebo comparator | Subjects will accept the offer of a virtual visit after being contacted by the nurse to offer a virtual visit with the oncologist prior to the in person office visit once a diagnosis has been confirmed. Subjects will be randomized after accepting offer of a virtual visit. Receives: Behavioral: Office visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment following diagnosis to treatment initiation
How long between diagnosis to treatment
Measured: 30 days
Secondary outcomes (3)
Amount of anxiety demonstrated when virtual visits are added
Level of anxiety using GAD-7
Measured: 30 days
Number of patients willing to pay for a virtual visit
Assess patients valuation of virtual visits by measuring their willingness to pay
Measured: 30 days
Number of patients with improved satisfaction scores
Determine whether the addition of a rapid virtual visit improves patients satisfaction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start27 Jun 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Why it stopped: PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Knight, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583736
- Sponsor's protocol ID
- CASE3818
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2018
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Patients With Uterine Cancer
- ClinicalTrials.gov ID
- NCT03583736
- Acronym / sponsor ID
- CASE3818
- Conditions
- Uterine Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 11 Jul 2018 (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.
This project aims to evaluate whether rapid first contact with the oncologist the same day or the next day after pathologic diagnosis contributes to a decreased time to treatment, decreased patient anxiety and increased patient satisfaction.
Detailed description
Time to treatment (time from disease diagnosis to initiation of treatment) impacts outcomes in uterine cancer. When controlled for stage, patients with longer time to treatment tend to have less favorable outcomes. Similarly, longer time to treatment has a negative impact on patients' quality of life and markers for anxiety. Our experience at this institution suggests that the time to referral (time from uterine cancer diagnosis and the patients' first encounter with the oncologist) is variable and presents the greatest opportunity for decreasing time to treatment. Among the factors that contribute to the time to referral are the time taken by the referring provider to relay the diagnosis to the patient, time taken to schedule an appointment with the specialist, and the patient's availability to keep an appointment.
Virtual visits provide an opportunity to expedite consultation with the treating oncologist by removing some of the barriers that delay face-to-face visits. Among these barriers are patients' availability for a short notice face-to-face visit based on their work or family obligations, access to transportation, and mental preparedness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid first contact virtual visit | Active comparator | Behavioral: Virtual visitSubjects will accept the offer of a virtual visit after being contacted by the nurse to offer a virtual visit with the oncologist prior to the in person office visit once a diagnosis has been confirmed. Subjects will be randomized after accepting offer of a virtual visit. |
| First contact in person office visit | Placebo comparator | Behavioral: Office visitSubjects will accept the offer of a virtual visit after being contacted by the nurse to offer a virtual visit with the oncologist prior to the in person office visit once a diagnosis has been confirmed. Subjects will be randomized after accepting offer of a virtual visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Uterine cancer diagnosis on biopsy read by Cleveland Clinic Pathology Department
- Patients must be willing to participate in a virtual visit as the initial meeting with an oncologist at the Cleveland Clinic.
- Receive care at Fairview Hospital, Hillcrest Hospital or Cleveland Clinic Main Campus
- Internet connected smartphone or internet connected computer with webcam
- Participants must have email access
Key exclusion criteria (1 listed)
- No diagnosis of uterine cancer
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 |
|---|---|---|
| Virtual visitVirtual visit with oncologist following uterine cancer diagnosis prior to scheduled office visit. | Behavioural | Rapid first contact virtual visit |
| Office visitScheduled office visit with oncologist following uterine cancer diagnosis. | Behavioural | First contact in person office visit |
Primary outcome
Time to treatment following diagnosis to treatment initiation
Time frame: 30 days
How long between diagnosis to treatment
3 secondary outcomes
Amount of anxiety demonstrated when virtual visits are added
Time frame: 30 days
Number of patients willing to pay for a virtual visit
Time frame: 30 days
Number of patients with improved satisfaction scores
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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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.
Jason Knight, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Virtual visit and Office visit in people with Uterine Cancer, run by Case Comprehensive Cancer Center.
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 7 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: withdrawn, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time to treatment following diagnosis to treatment initiation (time frame: 30 days). 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 30 Jun 2020; AzTrials last refreshed its copy on 2 Nov 2026.