Cancer
Conditions
Keywords
Mobile Health Technology, Geriatrics
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.
Interventions
BEHAVIORALM-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.
OTHERUsual Care
Participants randomized to the usual care arm will receive standard of care.
Sponsors
Kah Poh Loh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
• None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rates | 4-5 months | Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments |
| Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between experimental and active comparator arms - Quality of Life | 4-5 months | 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. |
| Difference between experimental and active comparator arms - Functional Status | 4-5 months | 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 |
| Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity | 4-5 months | 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. |
| Difference between experimental and active comparator arms - Healthcare Utilization | 4-5 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference between experimental and active comparator arms -Inflammatory cytokines | 4-5 months | Inflammatory cytokines including TNFα, sTNFR1, sTNFR2, IL-1β, IL-2, IL-6, sIL-6R, IL-8, IL-10 in pg/ml |
Countries
United States
Outcome results
None listed