Malignant Thoracic NeoplasmNCT06396598
Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer
A study testing Educational Activity, Electronic Health Record Review and Internet-Based Intervention in people with Malignant Thoracic Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Thoracic Neoplasm
- What is being tested?
- Educational Activity, Electronic Health Record Review and Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2024to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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
- Being tested
- Educational Activity, Electronic Health Record Review, Internet-Based Intervention, Media Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ActivityOther
Review education materials
Electronic Health Record ReviewOther
Ancillary studies
Internet-Based InterventionOther
Participate use the electronic symptom monitoring program to log symptoms
Media InterventionOther
Watch a video
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (electronic symptom monitoring program) | Experimental | 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. Receives: Other: Educational Activity; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Other: Media Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of symptom logging
Will estimate that ≥ 50% of patient participants will log symptoms at least monthly through the remote electronic symptom monitoring program.
Measured: At 6 months after enrollment
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.
Measured: At enrollment and 3 months
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.
Measured: At enrollment and 3 months and 6 months
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.
Measured: At enrollment and 3 months and 6 months
Secondary outcomes (1)
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).
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start9 Feb 2024
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Thoracic NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Julia Agne, Ohio State University Comprehensive Cancer Center
- Investigators
- Julia L Agne, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396598
- Sponsor's protocol ID
- OSU-23149
- Other IDs
- NCI-2024-00269
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program
- ClinicalTrials.gov ID
- NCT06396598
- Acronym / sponsor ID
- OSU-23149
- Conditions
- Malignant Thoracic Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (electronic symptom monitoring program) | Experimental | Other: Educational Activity, Other: Electronic Health Record Review, Other: Internet-Based Intervention, Other: Media Intervention, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational ActivityReview education materials | Other | Supportive Care (electronic symptom monitoring program) |
| Electronic Health Record ReviewAncillary studies | Other | Supportive Care (electronic symptom monitoring program) |
| Internet-Based InterventionParticipate use the electronic symptom monitoring program to log symptoms | Other | Supportive Care (electronic symptom monitoring program) |
| Media InterventionWatch a video | Other | Supportive Care (electronic symptom monitoring program) |
| Survey AdministrationAncillary studies | Other | Supportive Care (electronic symptom monitoring program) |
Primary outcome
Frequency of symptom logging
Time frame: At 6 months after enrollment
Will estimate that ≥ 50% of patient participants will log symptoms at least monthly through the remote electronic symptom monitoring program.
Proportion of patients enrolled (Feasibility)
Time frame: At enrollment and 3 months
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.
Symptom scores and Palliative Referral Association
Time frame: At enrollment and 3 months and 6 months
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.
Patient and Caregiver Symptom Reporting Congruency
Time frame: At enrollment and 3 months and 6 months
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.
1 secondary outcome
Palliative care referral patterns
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia L Agne, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Activity, Electronic Health Record Review and Internet-Based Intervention in people with Malignant Thoracic Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of symptom logging (time frame: At 6 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.