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

Sponsor
Carevive Systems, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05587972
Collaborator
(none)
100
1
14
7.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: survey
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 6, 2022
Anticipated Primary Completion Date :
Oct 6, 2023
Anticipated Study Completion Date :
Dec 6, 2023

Outcome Measures

Primary Outcome Measures

  1. Create data set [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Cleveland Ohio United States 44131

Sponsors and Collaborators

  • Carevive Systems, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carevive Systems, Inc.
ClinicalTrials.gov Identifier:
NCT05587972
Other Study ID Numbers:
  • OPT-IN Research Protocol
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2022