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CancerNCT07007039

Pilot Remote Therapeutic Monitoring in Cancer Patients

A study testing Datos Health App in people with Cancer, run by Shirley Ryan AbilityLab at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Cancer
What is being tested?
Datos Health App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
8 Sep 2025to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60657

Other trials in United States

About this study

Official title: Remote Therapeutic Monitoring: Pilot Implementation-Effectiveness Study

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.

Read the 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
Being tested
Datos Health App
Keywords
exercise, activity tracking, rehabilitation, remote monitoring
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Datos Health AppOther

    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.

Study groups in NCT07007039
Study groupRoleWhat they receive
Remote Therapeutic MonitoringOtherParticipants 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.
Receives: Other: Datos Health App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity Metric 1

    steps per day

    Measured: Daily, through study completion, average 3 months

  2. PROMIS 29+2

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

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

Secondary outcomes (2)

  1. Physical Activity Metric 2

    minutes of exercise in target heart rate zone

    Measured: Daily, through study completion, average 3 months

  2. Physical Activity Metric 3

    Number of strength training bouts

    Measured: weekly, through study completion, average 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start8 Sep 2025
  3. Primary completion20 Apr 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007039
Sponsor's protocol ID
STU00217608
Status last verified
Apr 2026
First submitted
28 May 2025
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30946436

  • 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.

    PubMed 35524146

  • 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.

    PubMed 31617590

  • 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.

    PubMed 33107982

  • 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.

    PubMed 35278203

  • 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.

    PubMed 34274004

  • 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.

    PubMed 28851459

  • 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.

    PubMed 31626055

  • 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.

    PubMed 38136443

Questions about this trial

What is this clinical trial studying?

A study testing Datos Health App in people with Cancer, run by Shirley Ryan AbilityLab at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity Metric 1 (time frame: Daily, through study completion, average 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007039, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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