Elektroniczny program monitorowania objawów w przypadku skierowań na leczenie paliatywne u pacjentów chorych na raka klatki piersiowej
SyMPLER: Skierowania paliatywne inicjowane przez pacjenta i opiekuna za pośrednictwem elektronicznego programu monitorowania objawów
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Ohio
-
Columbus, Ohio, Stany Zjednoczone, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Supportive Care (electronic symptom monitoring program)
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. |
Ancillary studies Review education materials Ancillary studies Participate use the electronic symptom monitoring program to log symptoms Watch a video |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Frequency of symptom logging
Ramy czasowe: 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. |
At 6 months after enrollment
|
|
Proportion of patients enrolled (Feasibility)
Ramy czasowe: 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. |
At enrollment and 3 months
|
|
Symptom scores and Palliative Referral Association
Ramy czasowe: 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. |
At enrollment and 3 months and 6 months
|
|
Patient and Caregiver Symptom Reporting Congruency
Ramy czasowe: 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. |
At enrollment and 3 months and 6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Palliative care referral patterns
Ramy czasowe: Up to 24 months
|
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
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Julia L Agne, MD, Ohio State University Comprehensive Cancer Center
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- OSU-23149
- NCI-2024-00269 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .