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

NCT ID: NCT05153447

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

M-Tech

Intervention Type: 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.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

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 Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kah Poh Loh

OTHER

Sponsor Role: lead

Responsible Party

Kah Poh Loh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

UCCS21086

Identifier Type: -

Identifier Source: org_study_id