Pilot Remote Therapeutic Monitoring in Cancer Patients

NCT07007039 | Active Not Recruiting

• 1 other identifier: STU00217608
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

exercise; activity tracking; rehabilitation; remote monitoring

Outcome Measures

Primary Outcomes (2)

• Physical Activity Metric 1

  steps per day

  Daily, through study completion, average 3 months

• PROMIS 29+2

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

  completed at baseline and at study completion, average of 3 months

Secondary Outcomes (2)

• Physical Activity Metric 2

  Daily, through study completion, average 3 months

• Physical Activity Metric 3

  weekly, through study completion, average 3 months

Study Arms (1)

Remote Therapeutic Monitoring

OTHER

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.

Other: Datos Health App

Interventions

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.

Remote Therapeutic Monitoring

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• o Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM in this pilot phase

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60657, United States

Location

Related Publications (9)

• Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.

  PMID: 30946436 BACKGROUND

• da Silva HEC, Santos GNM, Ferreira Leite A, Mesquita CRM, de Souza Figueiredo PT, Miron Stefani C, de Santos Melo N. The feasibility of telehealth in the monitoring of head and neck cancer patients: a systematic review on remote technology, user adherence, user satisfaction, and quality of life. Support Care Cancer. 2022 Oct;30(10):8391-8404. doi: 10.1007/s00520-022-07109-z. Epub 2022 May 6.

  PMID: 35524146 BACKGROUND

• Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, Ligibel JA, Cheville A, Galvao DA, Alfano CM, Patel AV, Hue T, Gerber LH, Sallis R, Gusani NJ, Stout NL, Chan L, Flowers F, Doyle C, Helmrich S, Bain W, Sokolof J, Winters-Stone KM, Campbell KL, Matthews CE. Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer. CA Cancer J Clin. 2019 Nov;69(6):468-484. doi: 10.3322/caac.21579. Epub 2019 Oct 16.

  PMID: 31617590 BACKGROUND

• Stout NL, Santa Mina D, Lyons KD, Robb K, Silver JK. A systematic review of rehabilitation and exercise recommendations in oncology guidelines. CA Cancer J Clin. 2021 Mar;71(2):149-175. doi: 10.3322/caac.21639. Epub 2020 Oct 27.

  PMID: 33107982 BACKGROUND

• Ficarra S, Thomas E, Bianco A, Gentile A, Thaller P, Grassadonio F, Papakonstantinou S, Schulz T, Olson N, Martin A, Wagner C, Nordstrom A, Hofmann H. Impact of exercise interventions on physical fitness in breast cancer patients and survivors: a systematic review. Breast Cancer. 2022 May;29(3):402-418. doi: 10.1007/s12282-022-01347-z. Epub 2022 Mar 12.

  PMID: 35278203 BACKGROUND

• Malone S, Prewitt K, Hackett R, Lin JC, McKay V, Walsh-Bailey C, Luke DA. The Clinical Sustainability Assessment Tool: measuring organizational capacity to promote sustainability in healthcare. Implement Sci Commun. 2021 Jul 17;2(1):77. doi: 10.1186/s43058-021-00181-2.

  PMID: 34274004 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

• Rosebrock K, Sinn M, Uzunoglu FG, Bokemeyer C, Jensen W, Salchow J. Effects of Exercise Training on Patient-Specific Outcomes in Pancreatic Cancer Patients: A Scoping Review. Cancers (Basel). 2023 Dec 18;15(24):5899. doi: 10.3390/cancers15245899.

  PMID: 38136443 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Miriam Rafferty, PT, DPT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Implementation Science

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: September 8, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)