A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥60 years
- •Have a new diagnosis of AML, MDS, MM, and DLBCL
- •Have a plan to receive outpatient chemotherapy for at least 4 months (patients may enroll within the first 2 weeks of chemotherapy initiation if they do not have grade 2 or higher non-hematologic adverse event)
- •No plan to or unlikely to proceed with autologous or allogeneic hematopoietic stem cell transplantation (SCT) in the following 5 months (if SCT is planned after 4 cycles of chemotherapy in the case of MDS or myeloma, patients are allowed to enroll)
- •English speaking
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •No medical contraindications for exercise per oncologist
- •Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without the assistive device)
- •Able to provide informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
M-Tech
M-Tech involves the use of a mobile app delivery platform to several interventions. The components of M-Tech include: 1) Hybrid in-person and telehealth visits with oncology providers; 2) Disease-specific education videos; 3) Activity level monitoring via a wearable device with promotion of physical activity; 4) Symptom monitoring with provision of self-management strategies, and 5) Medication management.
Intervention: M-Tech (Behavioral)
Usual Care
Participants randomized to the usual care arm will receive standard of care.
Intervention: Usual Care (Other)
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)
Investigators
Kah Poh Loh
Assistant Professor
University of Rochester