NCT03583736

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

June 27, 2018

Last Update Submit

June 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to treatment following diagnosis to treatment initiation

    How long between diagnosis to treatment

    30 days

Secondary Outcomes (3)

  • 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

Study Arms (2)

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.

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.

Behavioral: Office visit

Interventions

Virtual visitBEHAVIORAL

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

Rapid first contact virtual visit
Office visitBEHAVIORAL

Scheduled office visit with oncologist following uterine cancer diagnosis.

First contact in person office visit

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No diagnosis of uterine cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Jason Knight, MD

    Cleveland Clinic, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 11, 2018

Study Start

June 27, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06