Breast CancerNCT05974150
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
An observational study of Breast Cancer and Lung Cancer, run by Carevive Systems, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Multiple Myeloma
- What is being tested?
- Web based survey
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients receiving cancer treatment for breast, lung, GI or multiple myeloma
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Suzanne Johnson contact
7 sites in 1 country
United States7 sites, 4 recruiting
- Recruiting
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Janet Muckley, MUCKLEJ@ccf.org
Mitchell Haut, MD
- Completed
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
- Recruiting
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
Jill Severino-Powell, MSN, Jill.Severino-Powell@UHhospitals.org
Alberto Montero, MD
- Completed
Duke
Durham, North Carolina, 27707
- Recruiting
Northshore University Health System
Evanston, Illinois, 31024
Michele Britto, MBritto@northshore.org
Nicklas Pfanzelter
- Recruiting
Tri-County Hematology & Oncology Associates, Inc.
Massillon, Ohio, 44646
Janet Muckley, MUCKLEJ@ccf.org
Nagaprasad Nagajothi, MD
- Completed
Yale Cancer Center
New Haven, Connecticut, 06511
About this study
Official title: 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.
- Being tested
- Web based survey
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Multiple Myeloma, Ovarian Neoplasms, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web based surveyOther
online weekly survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Create Data Set
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start19 Jul 2023
- Primary completion5 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carevive Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974150
- Sponsor's protocol ID
- OPT-IN Carevive Registry
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring
- ClinicalTrials.gov ID
- NCT05974150
- Acronym / sponsor ID
- OPT-IN Carevive Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Carevive Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving cancer treatment for breast, lung, GI or multiple myeloma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web based surveyonline weekly survey | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Johnson contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Carevive Systems, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JULIE SCOTT, MSN (8778423210, Julie.scott@healthcatalyst.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create Data Set (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.