A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)

NCT05153447 | Withdrawn DMC

• 1 other identifier: UCCS21086
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Mobile Health Technology; Geriatrics

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Difference between experimental and active comparator arms - Healthcare Utilization

  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

• Difference between experimental and active comparator arms - Functional Status

  4-5 months

Other Outcomes (1)

• Difference between experimental and active comparator arms -Inflammatory cytokines

  4-5 months

Study Arms (2)

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.

Behavioral: M-Tech

Usual Care

ACTIVE COMPARATOR

Participants randomized to the usual care arm will receive standard of care.

Other: Usual Care

Interventions

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.

M-Tech

Usual Care OTHER

Participants randomized to the usual care arm will receive standard of care.

Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Kah Poh Loh: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)