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

NCT06396598 | Recruiting DMC

• 2 other identifiers: OSU-23149NCI-2024-00269
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Thoracic Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Palliative care referral patterns

  Up to 24 months

Study Arms (1)

Supportive Care (electronic symptom monitoring program)

EXPERIMENTAL

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: Educational Activity; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Other: Media Intervention; Other: Survey Administration

Interventions

Educational Activity OTHER

Review education materials

Supportive Care (electronic symptom monitoring program)

Electronic Health Record Review OTHER

Ancillary studies

Supportive Care (electronic symptom monitoring program)

Internet-Based Intervention OTHER

Participate use the electronic symptom monitoring program to log symptoms

Supportive Care (electronic symptom monitoring program)

Media Intervention OTHER

Watch a video

Supportive Care (electronic symptom monitoring program)

Survey Administration OTHER

Ancillary studies

Supportive Care (electronic symptom monitoring program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

Study Officials

• Julia L Agne, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 2, 2024
• Study Start: February 9, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)