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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-5 months
Awards & highlights
Summary
This trial assesses the feasibility and preliminary efficacy of a care delivery intervention in older patients with hematologic malignancies receiving outpatient chemotherapy.
Who is the study for?
This trial is for people aged 60 or older with certain blood cancers (AML, MDS, MM, DLBCL) who are getting outpatient chemo and can walk a short distance. They shouldn't be planning on stem cell transplants soon, must speak English, have an ECOG status of 0-3 indicating varying levels of activity, and no exercise restrictions from their doctor.Check my eligibility
What is being tested?
The study compares a new tech-supported care method called M-Tech to usual care in managing treatment side effects and improving patient outcomes during chemotherapy. It will also look at healthcare use and biological markers in patients.See study design
What are the potential side effects?
While specific side effects aren't listed for the M-Tech intervention itself since it's technology-based support during chemotherapy, typical chemo side effects may include fatigue, nausea, increased infection risk, hair loss, and potential impact on blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
Retention rates
Secondary outcome measures
Difference between experimental and active comparator arms - Functional Status
Difference between experimental and active comparator arms - Healthcare Utilization
Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity
+1 moreOther outcome measures
Difference between experimental and active comparator arms -Inflammatory cytokines
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: M-TechExperimental Treatment1 Intervention
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 II: Usual CareActive Control1 Intervention
Participants randomized to the usual care arm will receive standard of care.
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Who is running the clinical trial?
Kah Poh LohLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- There are no specific criteria for exclusion.You are able to walk a short distance of 4 meters, with or without the help of a walking aid.
Research Study Groups:
This trial has the following groups:- Group 1: M-Tech
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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