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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-07464 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0702 | Other Identifier | M D Anderson Cancer Center |
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This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.
PRIMARY OBJECTIVE:
I. Determine the efficacy of remote patient monitoring (RPM) on improving clinical outcomes.
SECONDARY OBJECTIVE:
I. Evaluate the following patient-centered outcomes: treatment delays, health-related quality-of-life (HRQOL), patient activation, and family caregiver-experience.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care consisting of oncology care provided via telemedicine.
ARM II: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard of care) | Active Comparator | Patients receive standard of care consisting of oncology care provided via telemedicine. |
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| Arm II (standard of care, remote monitoring) | Experimental | Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring. |
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| Arm III (standard of care, remote monitoring, biometrics) | Experimental | Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care telemedicine |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute care visits | Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life (HRQOL) | HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1. | Baseline to 6 months |
| Change in patient engagement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan W Huey, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36821818 | Derived | Offodile AC 2nd, Delgado D, Lin YL, Geyen D, Miller CJ, Jain S, Finder JP, Shete S, Fossella FV, Overman MJ, Peterson SK. Integration of Remote Symptom and Biometric Monitoring Into the Care of Adult Patients With Cancer Receiving Chemotherapy-A Decentralized Feasibility Pilot Study. JCO Oncol Pract. 2023 Jun;19(6):e811-e821. doi: 10.1200/OP.22.00676. Epub 2023 Feb 23. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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|
| Patient Monitoring | Procedure | Undergo remote monitoring |
|
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| Questionnaire Administration | Other | Ancillary studies |
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Patient engagement will be evaluated with the 13-item Patient Activation Measure (PAM), which assesses knowledge, skill, and self-efficacy for self-management of health
| Baseline to 6 months |
| Change in symptom management | Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5. | Baseline to 6 months |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D005770 | Gastrointestinal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
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