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

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.

Study Overview

• Status: Withdrawn
• Conditions: Uterine Cancer
• Intervention / Treatment: Behavioral: Virtual visit; Behavioral: Office visit

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rapid first contact virtual visit; 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.	Behavioral: Virtual visit; Virtual visit with oncologist following uterine cancer diagnosis prior to scheduled office visit.
PLACEBO_COMPARATOR: First contact in person office visit; 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.	Behavioral: Office visit; Scheduled office visit with oncologist following uterine cancer diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment following diagnosis to treatment initiation	How long between diagnosis to treatment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of anxiety demonstrated when virtual visits are added	Level of anxiety using GAD-7	30 days
Number of patients willing to pay for a virtual visit	Assess patients valuation of virtual visits by measuring their willingness to pay	30 days
Number of patients with improved satisfaction scores	Determine whether the addition of a rapid virtual visit improves patients satisfaction	30 days

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Jason Knight, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Uterine Neoplasms
• Other Study ID Numbers: CASE3818

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No