Back to resultsA Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study) (M-Tech)
Primary Purpose
Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M-Tech
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Mobile Health Technology, Geriatrics
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
M-Tech
Usual Care
Arm Description
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.
Participants randomized to the usual care arm will receive standard of care.
Outcomes
Primary Outcome Measures
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
Retention rates
Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments
Secondary Outcome Measures
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.
Difference between experimental and active comparator arms - Quality of Life
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
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 - 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05153447
Brief Title
A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
Acronym
M-Tech
Official Title
A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kah Poh Loh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Mobile Health Technology, Geriatrics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
M-Tech
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants randomized to the usual care arm will receive standard of care.
Intervention Type
Behavioral
Intervention Name(s)
M-Tech
Intervention Description
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
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants randomized to the usual care arm will receive standard of care.
Primary Outcome Measure Information:
Title
Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
Description
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
Time Frame
4-5 months
Title
Retention rates
Description
Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments
Time Frame
4-5 months
Secondary Outcome Measure Information:
Title
Difference between experimental and active comparator arms - Healthcare Utilization
Description
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.
Time Frame
4-5 months
Title
Difference between experimental and active comparator arms - Quality of Life
Description
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.
Time Frame
4-5 months
Title
Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity
Description
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.
Time Frame
4-5 months
Title
Difference between experimental and active comparator arms - Functional Status
Description
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
Time Frame
4-5 months
Other Pre-specified Outcome Measures:
Title
Difference between experimental and active comparator arms -Inflammatory cytokines
Description
Inflammatory cytokines including TNFα, sTNFR1, sTNFR2, IL-1β, IL-2, IL-6, sIL-6R, IL-8, IL-10 in pg/ml
Time Frame
4-5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kah Poh Loh
Phone
585-275-5863
Email
kahpoh_loh@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Terri Lloyd
Phone
585-276-5652
Email
terri_lloyd@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
We'll reach out to this number within 24 hrs