SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Symptom scores and Palliative Referral Association
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Educational Activity (Other)
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Internet-Based Intervention (Other)
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.
干预措施: Media Intervention (Other)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Symptom scores and Palliative Referral Association
时间窗: 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.
Frequency of symptom logging
时间窗: 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)
时间窗: 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.
Patient and Caregiver Symptom Reporting Congruency
时间窗: 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.
次要结局
- Palliative care referral patterns(Up to 24 months)
研究者
Julia Agne
Principal Investigator
Ohio State University Comprehensive Cancer Center