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

January 31, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (≥ 18 years)
  • English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital
  • Their adult (≥18 years) patient-identified or self-identified primary caregivers (MDACC only)
  • Participants on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion.
  • Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (standard of care)
Patients receive standard of care consisting of oncology care provided via telemedicine.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care telemedicine
Other Names:
  • standard of care
  • standard therapy
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: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care telemedicine
Other Names:
  • standard of care
  • standard therapy
Procedure: Patient Monitoring
Undergo remote monitoring
Other Names:
  • monitor
  • medical monitoring
Experimental: Arm III (standard of care, remote monitoring, biometrics)
Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care telemedicine
Other Names:
  • standard of care
  • standard therapy
Procedure: Patient Monitoring
Undergo remote monitoring
Other Names:
  • monitor
  • medical monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months
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
Baseline to 6 months
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.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Ryan W Huey, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0702 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-07464 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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