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

NCT ID: NCT06396598

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2026-02-28

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.

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.

Conditions

Malignant Thoracic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Activity

Intervention Type: OTHER

Review education materials

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Internet-Based Intervention

Intervention Type: OTHER

Participate use the electronic symptom monitoring program to log symptoms

Media Intervention

Intervention Type: OTHER

Watch a video

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Educational Activity

Review education materials

Intervention Type: OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Internet-Based Intervention

Participate use the electronic symptom monitoring program to log symptoms

Intervention Type: OTHER

Media Intervention

Watch a video

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Julia Agne

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia L Agne, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

The Ohio State Comprehensive Cancer Center

Role: CONTACT

OSUCCCClinicaltrials@osumc.edu

800-293-5066

Facility Contacts

Julia L. Agne, MD

Role: primary

Julia.Agne@osumc.edu

614-293-2957

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2024-00269

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-23149

Identifier Type: -

Identifier Source: org_study_id