Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer

SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program

This clinical trial evaluates earlier symptom management through remote electronic symptom monitoring (such as through an app on patient's phone), and accessibility of palliative care self-referral by patients with thoracic cancer and caregivers by proxy (legal representative). Thoracic cancer occurs in the chest and often causes symptoms for patients. Patients and/or their caregivers are often unable to attend in-person clinic visits for various reasons. The most frequently reported symptom by patients at initial palliative care consultations is pain, and caregivers' most common concerns are pain management for the patient, stress reduction, and fears about patient decline. Earlier palliative care referral can help control these symptoms before they worsen, providing a better quality of life for patients and caregivers. improve physical and emotional functioning for patients and caregivers in cancer care. This study may help researchers learn how an electronic symptom monitoring program may provide an earlier and more accessible way for patients with thoracic cancer to receive palliative care.

Study Overview

• Status: Recruiting
• Conditions: Malignant Thoracic Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Educational Activity; Other: Internet-Based Intervention; Other: Media Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. Develop and assess feasibility of a remote electronic symptom monitoring program with a prompted option for palliative care self-referral for patients or caregivers by proxy after diagnosis of a thoracic malignancy.

SECONDARY OBJECTIVE:

I. Evaluate palliative care referral patterns after implementation of a remote electronic symptom monitoring program.

OUTLINE:

Patients and their caregivers use the electronic symptom monitoring program to log symptoms once a week (QW) for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program.

After completion of study intervention, participants are followed up to 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 157
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Julia L. Agne, MD; Phone Number: 614-293-2957; Email: Julia.Agne@osumc.edu
      • Principal Investigator: Julia L. Agne, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• PATIENTS: Age ≥ 18 years
• PATIENTS: Diagnosed with any stage (1-4) or type (non-small cell lung cancer, small cell lung cancer, mesothelioma, thymic carcinoma) of thoracic malignancy
• PATIENTS: ≥ 2 visits at the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
• PATIENTS: Study enrollment within 12 weeks of initial Thoracic Medical Oncology appointment
• PATIENTS: Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
• PATIENTS: Ability to read and understand English
• PATIENTS: Access to a device with email or text messaging capability
• CAREGIVERS: Age ≥ 18 years
• CAREGIVERS: Identified by patient participant as primary caregiver
• CAREGIVERS: Corresponding patient participant has consented to participate in the study
• CAREGIVERS: Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
• CAREGIVERS: Ability to read and understand English
• CAREGIVERS: Access to a device with email or text messaging capability

Exclusion Criteria:

• PATIENTS: Patients who have been previously referred to ambulatory palliative care are excluded from participation
• PATIENTS: Prisoners are excluded from participation
• PATIENTS: Pregnant patients are excluded from participation
• PATIENTS: Patients who lack capacity for medical decision-making as determined by their primary oncologist are excluded from participation
• PATIENTS: There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (electronic symptom monitoring program); Patients and their caregivers participate use the electronic symptom monitoring program to log symptoms QW for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Educational Activity; Review education materials; Other: Internet-Based Intervention; Participate use the electronic symptom monitoring program to log symptoms; Other: Media Intervention; Watch a video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of symptom logging	Will estimate that ≥ 50% of patient participants will log symptoms at least monthly through the remote electronic symptom monitoring program.	At 6 months after enrollment
Proportion of patients enrolled (Feasibility)	Descriptive statistics will include study enrollment rates (eligible vs. ineligible participants, consented vs. refused), completion rate of weekly symptom monitoring (patient vs. caregiver by proxy), and person requesting palliative care services (patient vs. caregiver by proxy vs. medical provider), if applicable. Will be considered feasible if within 20% of target enrollment.	At enrollment and 3 months
Symptom scores and Palliative Referral Association	Symptom scores (Edmonton Symptom Assessment Scale revised with Constipation and Sleep [ESAS-r-CS]) reported by patients and caregivers will be tracked and their association with palliative care referral, if applicable, will be assessed.	At enrollment and 3 months and 6 months
Patient and Caregiver Symptom Reporting Congruency	Descriptive statistics will be used to assess for congruency between patient and proxy-reported symptom assessments. Patients' oncologic treatment (chemotherapy, immunotherapy, radiation therapy, surgery) will be abstracted from the electronic medical record (EMR) at the time of each ESAS-r-CS survey completed by either the patient or caregiver by proxy.	At enrollment and 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palliative care referral patterns	Palliative care referrals pre- and post- launch of the SyMPLER study will be evaluated for trends. Historical control data collecting palliative referrals by month will be compared between groups (pre-post- launch).	Up to 24 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Comprehensive Cancer Network
• Investigators: Principal Investigator: Julia L Agne, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: OSU-23149; NCI-2024-00269 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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