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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Metric 2 | minutes of exercise in target heart rate zone | Daily, through study completion, average 3 months |
| Physical Activity Metric 3 | Number of strength training bouts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Rafferty, PT, DPT, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60657 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30946436 | Background | 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. | |
| 35524146 | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| weekly, through study completion, average 3 months |
| 31617590 | 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. |
| 33107982 | 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. |
| 35278203 | 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. |
| 34274004 | 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. |
| 28851459 | 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. |
| 31626055 | 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. |
| 38136443 | 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. |