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

Primary Purpose

Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Patient Monitoring
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Clinical Stage IV Esophageal Adenocarcinoma AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard of care)

Arm II (standard of care, remote monitoring)

Arm Description

Patients receive standard of care consisting of oncology care provided via telemedicine.

Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in patient engagement
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
Change in symptom management
Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.

Full Information

First Posted
July 30, 2021
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05038254
Brief Title
Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care consisting of oncology care provided via telemedicine.
Arm Title
Arm II (standard of care, remote monitoring)
Arm Type
Experimental
Arm Description
Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care telemedicine
Intervention Type
Procedure
Intervention Name(s)
Patient Monitoring
Other Intervention Name(s)
medical monitoring, monitor
Intervention Description
Undergo remote monitoring
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Rate of acute care visits
Description
Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Change in health-related quality of life (HRQOL)
Description
HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.
Time Frame
Baseline to 6 months
Title
Change in patient engagement
Description
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
Time Frame
Baseline to 6 months
Title
Change in symptom management
Description
Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan W Huey, MD
Phone
713-792-2828
Email
rwhuey@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan W Huey, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan W Huey
Phone
713-792-2828
Email
rwhuey@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ryan W Huey

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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

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