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Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05038254
Recruitment Status : Recruiting
First Posted : September 9, 2021
Last Update Posted : February 27, 2023
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IVA Gastric Cancer AJCC v8 Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8 Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IVB Gastric Cancer AJCC v8 Metastatic Colon Carcinoma Metastatic Esophageal Carcinoma Metastatic Gastric Carcinoma Metastatic Liver Carcinoma Metastatic Malignant Digestive System Neoplasm Metastatic Malignant Small Intestinal Neoplasm Metastatic Malignant Thoracic Neoplasm Metastatic Pancreatic Carcinoma Metastatic Rectal Carcinoma Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IV Gastric Cancer AJCC v8 Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8 Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8 Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8 Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8 Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8 Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8 Stage IV Colon Cancer AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Rectal Cancer AJCC v8 Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8 Stage IVA Colon Cancer AJCC v8 Stage IVA Hepatocellular Carcinoma AJCC v8 Stage IVA Rectal Cancer AJCC v8 Stage IVB Colon Cancer AJCC v8 Stage IVB Hepatocellular Carcinoma AJCC v8 Stage IVB Rectal Cancer AJCC v8 Stage IVC Colon Cancer AJCC v8 Stage IVC Rectal Cancer AJCC v8 Other: Best Practice Procedure: Patient Monitoring Other: Questionnaire Administration Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: There Is No Place Like Home- A Pragmatic Effectiveness Trial of Technology-Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I (standard of care)
Patients receive standard of care consisting of oncology care provided via telemedicine.
 Other: Best Practice
Receive standard of care telemedicine
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies
Experimental: Arm II (standard of care, remote monitoring)
Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
 Other: Best Practice
Receive standard of care telemedicine
Other Names:
  • standard of care
  • standard therapy

Procedure: Patient Monitoring
Undergo remote monitoring
Other Names:
  • medical monitoring
  • monitor

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Rate of acute care visits [ Time Frame: Up to 3 months ]
    Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.


Secondary Outcome Measures :
  1. Change in health-related quality of life (HRQOL) [ Time Frame: Baseline to 6 months ]
    HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.

  2. Change in patient engagement [ Time Frame: Baseline to 6 months ]
    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

  3. Change in symptom management [ Time Frame: Baseline to 6 months ]
    Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (>= 18 years)
  • English- fluent with metastatic thoracic and gastrointestinal (esophagus, stomach, liver, pancreas, small bowel, colon, and rectum) who are scheduled to initiate outpatient chemotherapy (cycle 1, dose 1) at M D Anderson Cancer Center (MDACC) (Texas Medical Center location)
  • Their adult (>= 18 years) patient-identified or self-identified primary caregivers
  • Patients may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers may participate only if the patient consents

Exclusion Criteria:

  • Patients receiving investigational drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements
  • Patients with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05038254


Contacts
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Contact: Anaeze Offodile, MD 713-563-6785 ACOffodile@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anaeze Offodile    713-563-6785    ACOffodile@mdanderson.org   
Principal Investigator: Anaeze Offodile         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Anaeze Offodile, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05038254    
Other Study ID Numbers: 2020-0702
NCI-2021-07464 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0702 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma, Hepatocellular
Stomach Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Esophageal Squamous Cell Carcinoma
Gastrointestinal Stromal Tumors
Esophageal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Thoracic Neoplasms
 Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Neoplasms
Liver Diseases
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Diseases