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NCT Number: NCT07007039

Pilot Remote Therapeutic Monitoring in Cancer Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60657, United States

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Datos Health App

Other

Tracking participants step activity, workout frequency, minutes in target heart rate zone, and/or strength bouts completed over 3 month period. Individualized goals will be selected and set with a customized amount by a rehabilitation provider with at least monthly follow up contact to modify goals.

Primary outcomes

  1. Physical Activity Metric 1

    Time frame: Daily, through study completion, average 3 months

    steps per day

  2. PROMIS 29+2

    Time frame: completed at baseline and at study completion, average of 3 months

    A self report survey used to assess health report quality of life. It contains 31 total questions.

Secondary outcomes

  1. Physical Activity Metric 2

    Time frame: Daily, through study completion, average 3 months

    minutes of exercise in target heart rate zone

  2. Physical Activity Metric 3

    Time frame: weekly, through study completion, average 3 months

    Number of strength training bouts

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Remote Therapeutic Monitoring: Pilot Implementation-Effectiveness Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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