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

The Ohio State University

Status: Enrolling

Conditions: Malignant Thoracic Neoplasm

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

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06396598

OSU-23149

NCI-2024-00269 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

Supportive Care (electronic symptom monitoring program)

Experimental group

Description:

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.

Treatment:

Other: Media Intervention

Other: Internet-Based Intervention

Other: Electronic Health Record Review

Other: Educational Activity

Other: Survey Administration