Clinical trial NCT06396598: Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer
Official title: SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Thoracic Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2024-05-02
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Frequency of symptom logging
timeFrame: At 6 months after enrollment
measure: Proportion of patients enrolled (Feasibility)
timeFrame: At enrollment and 3 months
measure: Symptom scores and Palliative Referral Association
timeFrame: At enrollment and 3 months and 6 months
measure: Patient and Caregiver Symptom Reporting Congruency
timeFrame: At enrollment and 3 months and 6 months
Secondary outcomes:
measure: Palliative care referral patterns
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Julia L Agne, MD
role: PRINCIPAL_INVESTIGATOR
References: