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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-Tech | Experimental | 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. |
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| Usual Care | Active Comparator | Participants randomized to the usual care arm will receive standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-Tech | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity | 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 | 4-5 months |
| Retention rates | Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments | 4-5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between experimental and active comparator arms - Healthcare Utilization | Healthcare utilization such as hospitalization and emergency room visits in the first 4-5 months will be collected from medical chart review. These will be presented as proportions and count. | 4-5 months |
| Difference between experimental and active comparator arms - Quality of Life |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between experimental and active comparator arms -Inflammatory cytokines | Inflammatory cytokines including TNFα, sTNFR1, sTNFR2, IL-1β, IL-2, IL-6, sIL-6R, IL-8, IL-10 in pg/ml | 4-5 months |
Inclusion Criteria
Exclusion Criteria:
• None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Usual Care | Other | Participants randomized to the usual care arm will receive standard of care. |
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Quality of life, measured using the Functional Assessment of Cancer Therapy-Leukemia (FACT-G) scale. It consists of 27 items divided into 4 subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), and functional well-being (FWB). The score for each item ranges from 0-4. After reversing the scoring of negatively worded items, all the scores are summated. A higher score indicates better quality of life. |
| 4-5 months |
| Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity | Patient-reported treatment-related toxicity as measured using the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE). We selected 22 symptoms commonly experienced by older adults with hematologic malignancies. Questions ask about frequency, severity, and interference with daily activities (each question has 5 response options). We will convert these response options to 0-5 and sum up the scores, higher score indicates worse severity and interference. | 4-5 months |
| Difference between experimental and active comparator arms - Functional Status | Functional status, measured using the instrumental activities of daily living subscale of the Multidimensional Functional Assessment Questionnaire: Older American Resources and Services (OARS). The IADL subscale consists of seven questions rated on a three-point Likert scale. It measures the degree to which an activity can be performed independently. A higher score indicates better functional status | 4-5 months |