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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583736
Recruitment Status : Withdrawn (PI decision)
First Posted : July 11, 2018
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uterine Cancer Behavioral: Virtual visit Behavioral: Office visit Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Patients With Uterine Cancer
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to treatment following diagnosis to treatment initiation [ Time Frame: 30 days ]
    How long between diagnosis to treatment


Secondary Outcome Measures :
  1. Amount of anxiety demonstrated when virtual visits are added [ Time Frame: 30 days ]
    Level of anxiety using GAD-7

  2. Number of patients willing to pay for a virtual visit [ Time Frame: 30 days ]
    Assess patients valuation of virtual visits by measuring their willingness to pay

  3. Number of patients with improved satisfaction scores [ Time Frame: 30 days ]
    Determine whether the addition of a rapid virtual visit improves patients satisfaction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583736


Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Jason Knight, MD Cleveland Clinic, Case Comprehensive Cancer Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03583736    
Other Study ID Numbers: CASE3818
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases