Pilot Remote Therapeutic Monitoring in Cancer Patients

NCT ID: NCT07007039

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Remote Therapeutic Monitoring

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.

Group Type: OTHER

Datos Health App

Intervention Type: 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.

Interventions

Datos Health App

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Miriam Rafferty

Director of Implementation Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam Rafferty, PT, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Central Contacts

Miriam Rafferty, PT, DPT, PhD

Role: CONTACT

mrafferty@sralab.org

312-238-7233

Kristen Hohl, PT, DPT

Role: CONTACT

khohl@sralab.org

312-238-1378

References

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Other Identifiers

STU00217608

Identifier Type: -

Identifier Source: org_study_id