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

Primary Purpose

Uterine Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual visit
Office visit
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Uterine Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Rapid first contact virtual visit

    First contact in person office visit

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Time to treatment following diagnosis to treatment initiation
    How long between diagnosis to treatment

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 27, 2018
    Last Updated
    June 29, 2020
    Sponsor
    Case Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03583736
    Brief Title
    Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Uterine Cancer
    Official Title
    Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Patients With Uterine Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI decision
    Study Start Date
    June 27, 2018 (Actual)
    Primary Completion Date
    June 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rapid first contact virtual visit
    Arm Type
    Active Comparator
    Arm 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 Title
    First contact in person office visit
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual visit
    Intervention Description
    Virtual visit with oncologist following uterine cancer diagnosis prior to scheduled office visit.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Office visit
    Intervention Description
    Scheduled office visit with oncologist following uterine cancer diagnosis.
    Primary Outcome Measure Information:
    Title
    Time to treatment following diagnosis to treatment initiation
    Description
    How long between diagnosis to treatment
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Amount of anxiety demonstrated when virtual visits are added
    Description
    Level of anxiety using GAD-7
    Time Frame
    30 days
    Title
    Number of patients willing to pay for a virtual visit
    Description
    Assess patients valuation of virtual visits by measuring their willingness to pay
    Time Frame
    30 days
    Title
    Number of patients with improved satisfaction scores
    Description
    Determine whether the addition of a rapid virtual visit improves patients satisfaction
    Time Frame
    30 days

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jason Knight, MD
    Organizational Affiliation
    Cleveland Clinic, Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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