CancerM-TechNCT05153447
A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
A study testing M-Tech in people with Cancer, run by Kah Poh Loh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- M-Tech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- M-Tech, Usual Care
- Keywords
- Mobile Health Technology, Geriatrics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TechBehavioural
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 CareOther
Participants randomized to the usual care arm will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: M-Tech |
| Usual Care | Active comparator | Participants randomized to the usual care arm will receive standard of care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-5 months
Retention rates
Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments
Measured: 4-5 months
Secondary outcomes (4)
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.
Measured: 4-5 months
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.
Measured: 4-5 months
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.
Measured: 4-5 months
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
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Unable to obtain funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kah Poh Loh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kah Poh Loh, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153447
- Sponsor's protocol ID
- UCCS21086
- Acronym
- M-Tech
- Status last verified
- Jan 2024
- First submitted
- 16 Nov 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
- ClinicalTrials.gov ID
- NCT05153447
- Acronym / sponsor ID
- M-Tech / UCCS21086
- Conditions
- Cancer
- Keywords
- Mobile Health Technology, Geriatrics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kah Poh LohUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-Tech | Experimental | Behavioral: M-TechM-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 | Active comparator | Other: Usual CareParticipants randomized to the usual care arm will receive standard of care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-TechM-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. | Behavioural | M-Tech |
| Usual CareParticipants randomized to the usual care arm will receive standard of care. | Other | Usual Care |
Primary outcome
Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
Time frame: 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
Time frame: 4-5 months
Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments
4 secondary outcomes
Difference between experimental and active comparator arms - Healthcare Utilization
Time frame: 4-5 months
Difference between experimental and active comparator arms - Quality of Life
Time frame: 4-5 months
Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity
Time frame: 4-5 months
Difference between experimental and active comparator arms - Functional Status
Time frame: 4-5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-Tech in people with Cancer, run by Kah Poh Loh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity (time frame: 4-5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.