A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Kah Poh Loh
- Locations
- 1
- Primary Endpoint
- Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomized controlled trial to assess the feasibility and preliminary efficacy of a multicomponent technology-supported care delivery intervention trial in 110 older patients with hematologic malignancies [acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), multiple myeloma (MM), and diffuse large b-cell lymphoma (DLBCL)] receiving outpatient chemotherapy on treatment-related toxicities, patient-reported outcomes, healthcare utilization, and inflammatory and epigenetic markers.
Detailed Description
Compared to younger adults, older adults with cancer are more likely to have age-related vulnerabilities such as functional impairment and co-existing medical conditions. They are also often on many medications. As a result, older adults are more likely to experience treatment-related toxicities. These toxicities can lead to increased healthcare utilization (e.g., hospitalization, emergency room visits), decreased quality of life and functional status, and reduced survival. In addition, a disproportionate number of older adults live in rural areas which often limit access to healthcare. Therefore, there is a need to better support older adults with hematologic malignancies during the course of their treatment to decrease treatment-related toxicities so they can continue to receive treatment. The proposed study will investigate whether digital health technologies can support older adults in various aspects of their cancer care.
Investigators
Kah Poh Loh
Assistant Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
Time Frame: 4-5 months
Measured using the Common Terminology Criteria for Adverse Events or CTCAE v5.0 and operationalized based on proportion of patients with grade 3-5 non-hematologic treatment-related toxicity for AML, MDS, and DLBCL or grade 2-5 non-hematologic treatment-related toxicity for MM
Retention rates
Time Frame: 4-5 months
Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments
Secondary Outcomes
- Difference between experimental and active comparator arms - Healthcare Utilization(4-5 months)
- Difference between experimental and active comparator arms - Functional Status(4-5 months)
- Difference between experimental and active comparator arms - Quality of Life(4-5 months)
- Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity(4-5 months)