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

Primary Purpose

Breast Cancer, Lung Cancer, Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
survey
Sponsored by
Carevive Systems, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Cleveland ClinicRecruiting

Outcomes

Primary Outcome Measures

Create data set
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.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2022
Last Updated
October 18, 2022
Sponsor
Carevive Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05587972
Brief Title
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Official Title
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carevive Systems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Gastrointestinal Cancer, Multiple Myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
survey
Intervention Description
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 PRO surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks.
Primary Outcome Measure Information:
Title
Create data set
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Scott, MSN
Phone
8778423210
Email
julie.scott@carevive.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Galaznik, MD
Organizational Affiliation
Carevive Systems, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIsa Mirossay
Phone
216-986-4427
Email
lmirossa@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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