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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974150
• Other study ID #: OPT-IN Carevive Registry
• Status: Recruiting
• Start date: July 19, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Carevive Systems, Inc.
• Contact: JULIE SCOTT, MSN
• Phone: 8778423210
• Email: Julie.Scott[@]Carevive.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT05974137

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: July 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Breast Cancer
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lung Cancer
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Ovarian Cancer

Intervention

Other:
• Web based survey
online weekly survey

Locations

Country	Name	City	State
United States	Cleveland Clinic Mercy Hospital	Canton	Ohio
United States	Univeristy of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University Hospitals Seidman Cancer Center	Cleveland	Ohio
United States	Duke	Durham	North Carolina
United States	Northshore University Health System	Evanston	Illinois
United States	Tri-County Hematology & Oncology Associates, Inc.	Massillon	Ohio
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Carevive Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create Data Set	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