- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974150
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: JULIE SCOTT, MSN
- Phone Number: 8778423210
- Email: Julie.Scott@Carevive.com
Study Locations
-
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Connecticut
-
New Haven, Connecticut, United States, 06511
- Completed
- Yale Cancer Center
-
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Illinois
-
Evanston, Illinois, United States, 31024
- Recruiting
- NorthShore University Health System
-
Contact:
- Michele Britto
- Email: mbritto@northshore.org
-
Principal Investigator:
- Nicklas Pfanzelter
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Completed
- Univeristy of North Carolina at Chapel Hill
-
Durham, North Carolina, United States, 27707
- Completed
- Duke
-
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Ohio
-
Canton, Ohio, United States, 44708
- Recruiting
- Cleveland Clinic Mercy Hospital
-
Principal Investigator:
- Mitchell Haut, MD
-
Contact:
- Janet Muckley
- Email: MUCKLEJ@ccf.org
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Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Seidman Cancer Center
-
Contact:
- Jill Severino-Powell, MSN
- Email: Jill.Severino-Powell@UHhospitals.org
-
Principal Investigator:
- Alberto Montero, MD
-
Massillon, Ohio, United States, 44646
- Recruiting
- Tri-County Hematology & Oncology Associates, Inc.
-
Principal Investigator:
- Nagaprasad Nagajothi, MD
-
Contact:
- Janet Muckley
- Email: MUCKLEJ@ccf.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Immune System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Genital Diseases, Female
- Lung Diseases
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Skin Diseases
- Breast Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, Myeloid
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Leukemia
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Lung Neoplasms
- Leukemia, Myeloid, Acute
- Ovarian Neoplasms
- Breast Neoplasms
- Multiple Myeloma
Other Study ID Numbers
- OPT-IN Carevive Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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