Remote Therapeutic Monitoring: Pilot Implementation-Effectiveness Study
| Registry | NCT07007039 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, supportive care |
| Enrollment | 25 (Estimated) |
| Sponsor | Shirley Ryan AbilityLab (Other) |
| Conditions | Cancer |
| Interventions | Datos Health App (Other) |
| Dates | start 2025-09-08, primary completion 2026-04-20 (estimated), completion 2027-04-01 (estimated), first posted 2025-06-05, last updated 2026-04-20 |
| Locations | 1 site in United States |
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The goal of this clinical trial is to learn about exercise and physical activity in individuals who are undergoing cancer treatment. The clinical trial is embedded in a pilot implementation feasibility study. The main implementation questions it aims to answer are to understand the implementation feasibility, acceptability and appropriateness of remote monitoring from providers and participants. The main clinical trial outcomes are to explore the effectiveness of remote therapeutic monitoring to achieve individual goal attainment related to exercise defined as number of daily steps, weekly exercise minutes, strength sessions or decreased physical activity variability.
During the course of the study: Participants will use activity trackers and a mobile phone application to monitor their exercise participation over 3 months.
The study aims to evaluate the implementation and clinical effectiveness of Remote Therapeutic Monitoring (RTM) in cancer rehabilitation. RTM is a reimbursable tool that enables clinicians (physical therapists, occupational therapists, and physicians) to remotely monitor adherence to exercise and physical activity (PA), addressing barriers such as limited time and energy for in-person appointments during cancer treatment. We will implement three months of RTM in 20 individuals undergoing or within six months of chemotherapy, immunotherapy, or cell therapy. We will evaluate the following aims:
1\. Implementation Outcomes: Assess RTM's feasibility, acceptability, appropriateness, sustainability, and satisfaction from the perspectives of therapists, physicians, and patients using validated questionnaires and interviews.
2: Clinical Trial Outcomes: Measure RTM's effectiveness in achieving patient-centered goals, such as increasing or maintaining exercise, PA, strength training, or energy conservation, and its impact on quality of life using PROMIS-29+2.
The findings will inform future large-scale research and enhance cancer rehabilitation outcomes by improving accessibility and personalized care through RTM integration.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Remote Therapeutic Monitoring | Other | Other: Datos Health App | Participants will receive 3 months of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors. |
Sex: All, ages: 18 Years to 89 Years
Inclusion Criteria: * Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community * Have a diagnosis of cancer (undergoing chemo, radiation, surgery, immunotherapy, or cell therapy (transplants and Chimeric Antigen Receptor t-cell therapy (CAR-T)) or in cancer survivorship * Participating in Outpatient rehabilitation services at time of enrollment, or recommended by physician for participation in study * Have a goal to increase or maintain physical activity (e.g., steps per day or minutes of moderate to vigorous exercise per week) or strength bouts - personal goal and willingness to address physical activity * Have a smart phone * Willing to accept Datos' Terms and Conditions Exclusion Criteria: * o Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM in this pilot phase
| Facility | City | Country | Status |
|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago, Illinois | United States |