Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring

Sponsor
Carevive Systems, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05974150
Collaborator
(none)
25
7
17.4
3.6
0.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Web based survey

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring
Actual Study Start Date :
Jul 19, 2023
Anticipated Primary Completion Date :
Jul 5, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Create Data Set [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

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 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale Cancer Center New Haven Connecticut United States 06511
2 Northshore University Health System Evanston Illinois United States 31024
3 Univeristy of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
4 Duke Durham North Carolina United States 27707
5 Cleveland Clinic Mercy Hospital Canton Ohio United States 44708
6 University Hospitals Seidman Cancer Center Cleveland Ohio United States 44106
7 Tri-County Hematology & Oncology Associates, Inc. Massillon Ohio United States 44646

Sponsors and Collaborators

  • Carevive Systems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carevive Systems, Inc.
ClinicalTrials.gov Identifier:
NCT05974150
Other Study ID Numbers:
  • OPT-IN Carevive Registry
  • NCT05974137
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
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 Aug 9, 2023