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

Not Applicable

Withdrawn

• Conditions: Cancer

• Registration Number: NCT05153447
• Lead Sponsor: Kah Poh Loh

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.

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-10
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Retention rates	4-5 months	Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments

Secondary Outcome Measures

Name	Time	Method
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.
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 - 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 - 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.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States