Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring

Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05587972

Recruitment Status : **RECRUITING NOW**
First Posted : October 20, 2022
Last Update Posted : October 20, 2022

Sponsor:

Information provided by (Responsible Party):
Carevive Systems, Inc.

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Brief Summary:
The Carevive registry collects patient characteristics, patient symptoms, and treatment experience data from patients receiving cancer treatment for breast, lung, GI or multiple myeloma. For this study, a core set of variables is collected on each patient in the Carevive platform. 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 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.

Breast Cancer Lung Cancer Gastrointestinal Cancer Multiple Myeloma
Other: survey
Not Applicable

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Study Type :
Interventional  (Clinical Trial)

Estimated Enrollment :
100 participants

Allocation:
N/A

Intervention Model:
Single Group Assignment

Masking:
None (Open Label)

Primary Purpose:
Supportive Care

Official Title:
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring

Actual Study Start Date :
October 6, 2022

Estimated Primary Completion Date :
October 6, 2023

Estimated Study Completion Date :
December 6, 2023

Resource links provided by the National Library of Medicine

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Intervention Details:

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Primary Outcome Measures :

Create data set [ Time Frame: 12 weeks ]
Project outcome measures for this project are the prevalence, frequency, and severity of symptoms in each disease group, longitudinal change in symptom experience, and time on treatment from enrollment to next treatment.

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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:  
18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

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 breast, lung, GI or 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).

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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05587972

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Cleveland Clinic

Cleveland, Ohio, United States, 44131

Contact: LIsa Mirossay    216-986-4427    lmirossa@ccf.org   

Carevive Systems, Inc.

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Study Director:
Aaron Galaznik, MD
Carevive Systems, Inc.

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Responsible Party:
Carevive Systems, Inc.

ClinicalTrials.gov Identifier:
NCT05587972    

Other Study ID Numbers:
OPT-IN Research Protocol

First Posted:
October 20, 2022    Key Record Dates

Last Update Posted:
October 20, 2022

Last Verified:
October 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:
No

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Studies a U.S. FDA-regulated Drug Product:
No

Studies a U.S. FDA-regulated Device Product:
No

Additional relevant MeSH terms:

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Cardiovascular DiseasesMultiple MyelomaNeoplasms, Plasma CellGastrointestinal NeoplasmsNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesParaproteinemiasBlood Protein Disorders
Hematologic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 21, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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