Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Patients With Uterine Cancer

Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Uterine Cancer



Sponsors


Source

Case Comprehensive Cancer Center

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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.

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.

Overall Status

Not yet recruiting

Start Date

2018-08-08

Completion Date

2019-04-01

Primary Completion Date

2019-04-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Time to treatment following diagnosis to treatment initiation
30 days

Secondary Outcome

Measure

Time Frame

Amount of anxiety demonstrated when virtual visits are added
30 days
Number of patients willing to pay for a virtual visit
30 days
Number of patients with improved satisfaction scores
30 days

Enrollment

40

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Virtual visit with oncologist following uterine cancer diagnosis prior to scheduled office visit.

Arm Group Label

Rapid first contact virtual visit


Intervention Type

Behavioral

Intervention Name


Description

Scheduled office visit with oncologist following uterine cancer diagnosis.

Arm Group Label

First contact in person office visit



Eligibility

Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- No diagnosis of uterine cancer

Gender

Female

Gender Based

Yes

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Jason Knight, MD
Principal Investigator
Cleveland Clinic, Case Comprehensive Cancer Center

Overall Contact

Last Name

Jason Knight, MD

Phone

866-223-8100

Email



Location

Facility

Status

Contact

Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland Ohio 44195 United States
Not yet recruiting
Last Name: Jason Knight, MD
Phone: 866-223-8100
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Rapid first contact virtual visit

Arm Group Type

Active Comparator

Description

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.


Arm Group Label

First contact in person office visit

Arm Group Type

Placebo Comparator

Description

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.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

None (Open Label)


Study First Submitted

June 27, 2018

Study First Submitted Qc

June 27, 2018

Study First Posted

July 11, 2018

Last Update Submitted

June 27, 2018

Last Update Submitted Qc

June 27, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on July 11, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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