What side effects are associated with this type of intervention?

Common treatments for leukemia, such as chemotherapy and targeted therapy, often come with a range of side effects. Chemotherapy can cause fatigue, nausea, vomiting, hair loss, and increased risk of infections due to lowered white blood cell counts. Targeted therapies may lead to side effects like diarrhea, liver problems, and skin rashes. Radiation therapy, though less common, can cause skin irritation and fatigue. Technology-assisted in-home oncology care, including remote monitoring and telemedicine, can help manage these side effects by providing timely medical support and reducing the need for frequent hospital visits.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of leukemia, including hypomethylating agents like azacitidine and decitabine, which can be administered in outpatient settings and are suitable for home-based care. Azacitidine, for instance, can be given subcutaneously, making it feasible for home administration with proper monitoring. Additionally, the FDA has approved an oral preparation of azacitidine (CC-486) for post-remission maintenance therapy of AML, which aligns well with remote patient monitoring and telemedicine. These approvals support the potential for technology-assisted in-home oncology care, enhancing patient convenience and adherence to treatment protocols.

What other types of research exist?

Promising novel alternatives to technology-assisted in-home oncology care for leukemia patients include: 1) Combination therapies such as Decitabine plus Venetoclax, which have shown improved outcomes in clinical trials. 2) Reduced intensity or nonmyeloablative hematopoietic cell transplantation (HCT), which has demonstrated potential benefits in chronic lymphocytic leukemia (CLL) and may be applicable to other leukemia types. 3) The use of 5G technology for remote robotic-assisted procedures, which could enhance precision and access to advanced treatments. These alternatives offer new avenues for effective leukemia management and should be discussed with a healthcare provider.

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Remote Monitoring & Telemedicine for Leukemia Care

N/A

Waitlist Available

Led By Glen Peterson

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to help cancer patients manage their care at home using technology. It focuses on patients who have had bone marrow transplants or CAR-T therapy. The technology allows doctors to monitor patients' health remotely and provide quick medical advice and treatment when needed.

Who is the study for?

This trial is for adults aged 18-89 with leukemia who are stable enough to be discharged home after a bone marrow transplant or CAR-T therapy. They must have caregiver support, reliable phone and internet service, live within 45 minutes of the AMC in Denver, and agree to use technology for remote care.

What is being tested?

The study tests an at-home oncology care program using BioIntelliSense BioButton and Memora Health platform for patients post-BMT or CAR-T. It includes remote monitoring, telemedicine, and home health services to improve care coordination.

What are the potential side effects?

Since this trial focuses on technology-assisted care rather than medication, traditional side effects aren't applicable. However, participants may experience issues related to device wearability or technical difficulties with the platforms used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients reporting symptoms

Secondary study objectives

EPRO patient response rates

Patient retention rate

Total number of patient interactions with RC

Other study objectives

Overall caregiver satisfaction

Overall health care provider satisfaction

Overall patient satisfaction

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Post BMT or CAR-T patients receiving care at UCHealthExperimental Treatment2 Interventions

Participants will be recruited for this study from among three discrete patient populations: * Allogeneic BMT patients receiving care at UCHealth who are planning to reside in the Denver metro area within 45 minutes of the Anschutz Medical Campus (AMC) for at least 90 days post-transplant. * Autologous BMT patients receiving care at UCHealth who are planning to reside in the Denver metro Area within 45 minutes of the AMC for at least 30 days post-transplant. * CAR-T patients receiving care at UCHealth who are planning to reside in the Denver metro area within 45 minutes of the AMC for at least 30 days post treatment.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for leukemia include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy involves agents like Bruton tyrosine kinase (BTK) inhibitors and BCL2 inhibitors that specifically target molecular abnormalities in leukemia cells. Immunotherapy, such as CAR-T cell therapy, harnesses the patient's immune system to attack cancer cells. These treatments are crucial for leukemia patients as they aim to reduce the disease burden, improve survival rates, and enhance quality of life. Technology-assisted in-home oncology care, including remote monitoring and telemedicine, can support these treatments by providing continuous care, early detection of complications, and personalized management, thereby improving overall treatment outcomes.

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