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

Recruiting

• Conditions: Lung Cancer; Multiple Myeloma; Breast Cancer; Ovarian Cancer; Acute Myelogenous Leukemia

• Registration Number: NCT05974150
• Lead Sponsor: Carevive Systems, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-19
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-11-05
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Create Data Set	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

Trial Locations

Locations (7)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Northshore University Health System; 🇺🇸 Evanston, Illinois, United States

Univeristy of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke; 🇺🇸 Durham, North Carolina, United States

University Hospitals Seidman Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Mercy Hospital; 🇺🇸 Canton, Ohio, United States

Tri-County Hematology & Oncology Associates, Inc.; 🇺🇸 Massillon, Ohio, United States