Clinical trial NCT05153447: A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
Official title: A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Keywords: Mobile Health Technology
Geriatrics
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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:

• None

Primary outcomes:
measure: Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
timeFrame: 4-5 months
measure: Retention rates
timeFrame: 4-5 months
Secondary outcomes:
measure: Difference between experimental and active comparator arms - Healthcare Utilization
timeFrame: 4-5 months
measure: Difference between experimental and active comparator arms - Quality of Life
timeFrame: 4-5 months
measure: Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity
timeFrame: 4-5 months
measure: Difference between experimental and active comparator arms - Functional Status
timeFrame: 4-5 months
Other outcomes:
measure: Difference between experimental and active comparator arms -Inflammatory cytokines
timeFrame: 4-5 months
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: