Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring

August 8, 2023 updated by: Carevive Systems, Inc.

Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring

The goal of this study is to create a data set to add to Carevive's registry from real world clinical and patient reported data collected using an electronic care planning system (CPS) with remote symptom monitoring that is used in routine care for cancer patients on active treatment.

Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic patient reported outcome (PRO) surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Cancer Center
        • Contact:
        • Principal Investigator:
          • Kim Blenman
    • Illinois
      • Evanston, Illinois, United States, 31024
        • Recruiting
        • NorthShore University Health System
        • Contact:
        • Principal Investigator:
          • Nicklas Pfanzelter
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Univeristy of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Ashley Bryant, Ph.D
      • Durham, North Carolina, United States, 27707
        • Recruiting
        • Duke
        • Contact:
        • Principal Investigator:
          • Thomas Leblanc, MD
    • Ohio
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Cleveland Clinic Mercy Hospital
        • Principal Investigator:
          • Mitchell Haut, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
      • Massillon, Ohio, United States, 44646
        • Recruiting
        • Tri-County Hematology & Oncology Associates, Inc.
        • Principal Investigator:
          • Nagaprasad Nagajothi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients receiving cancer treatment for breast, lung, GI or multiple myeloma

Description

Inclusion Criteria:

  • All participants must be 18 years of age or older.
  • Subjects may be any stage and anywhere in the treatment continuum.
  • Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.
  • Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
  • All participants must be able to understand English.

Exclusion Criteria:

  • Any patient who cannot understand written or spoken English.
  • Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
  • Any patient on a treatment clinical trial.
  • Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Create Data Set
Time Frame: 1 year
The goal of this registry is to create a data set from real world clinical and patient reported data collected using an electronic care planning system (CPS) that is used in routine care for cancer patients on active treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carevive Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Estimated)

July 5, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT-IN Carevive Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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