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

Malignant Thoracic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06396598
• Other study ID #: OSU-23149
• Secondary ID: NCI-2024-00269
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 157
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Thoracic Neoplasm
• Thoracic Neoplasms

Intervention

Other:
• Educational Activity
Review education materials
• Electronic Health Record Review
Ancillary studies
• Internet-Based Intervention
Participate use the electronic symptom monitoring program to log symptoms
• Media Intervention
Watch a video
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

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