Trial Title:
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
NCT ID:
NCT05974150
Condition:
Breast Cancer
Lung Cancer
Multiple Myeloma
Ovarian Cancer
Acute Myelogenous Leukemia
Conditions: Official terms:
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Web based survey
Description:
online weekly survey
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.
Criteria for eligibility:
Study pop:
patients receiving cancer treatment for breast, lung, GI or multiple myeloma
Sampling method:
Non-Probability Sample
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Blenman
Email:
kim.blenman@yale.edu
Investigator:
Last name:
Kim Blenman
Email:
Principal Investigator
Facility:
Name:
Northshore University Health System
Address:
City:
Evanston
Zip:
31024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michele Britto
Email:
MBritto@northshore.org
Investigator:
Last name:
Nicklas Pfanzelter
Email:
Principal Investigator
Facility:
Name:
Univeristy of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Duke
Address:
City:
Durham
Zip:
27707
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Cleveland Clinic Mercy Hospital
Address:
City:
Canton
Zip:
44708
Country:
United States
Status:
Recruiting
Contact:
Last name:
Janet Muckley
Email:
MUCKLEJ@ccf.org
Investigator:
Last name:
Mitchell Haut, MD
Email:
Principal Investigator
Facility:
Name:
University Hospitals Seidman Cancer Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jill Severino-Powell, MSN
Email:
Jill.Severino-Powell@UHhospitals.org
Investigator:
Last name:
Alberto Montero, MD
Email:
Principal Investigator
Facility:
Name:
Tri-County Hematology & Oncology Associates, Inc.
Address:
City:
Massillon
Zip:
44646
Country:
United States
Status:
Recruiting
Contact:
Last name:
Janet Muckley
Email:
MUCKLEJ@ccf.org
Investigator:
Last name:
Nagaprasad Nagajothi, MD
Email:
Principal Investigator
Start date:
July 19, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Carevive Systems, Inc.
Agency class:
Industry
Source:
Carevive Systems, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05974150
