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Trial Title:
Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer
NCT ID:
NCT06396598
Condition:
Malignant Thoracic Neoplasm
Conditions: Official terms:
Thoracic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Educational Activity
Description:
Review education materials
Arm group label:
Supportive Care (electronic symptom monitoring program)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Supportive Care (electronic symptom monitoring program)
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Participate use the electronic symptom monitoring program to log symptoms
Arm group label:
Supportive Care (electronic symptom monitoring program)
Intervention type:
Other
Intervention name:
Media Intervention
Description:
Watch a video
Arm group label:
Supportive Care (electronic symptom monitoring program)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (electronic symptom monitoring program)
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.
Criteria for 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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia L. Agne, MD
Phone:
614-293-2957
Email:
Julia.Agne@osumc.edu
Investigator:
Last name:
Julia L. Agne, MD
Email:
Principal Investigator
Start date:
February 9, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Comprehensive Cancer Network
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06396598
http://cancer.osu.edu
