Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,798
- 试验地点
- 46
- 主要终点
- Patient-reported Quality of Life
研究概览
简要总结
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
详细描述
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about the cancer diagnosis.
Research has shown that early involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their families cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with the oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they have better symptom control, quality of life, and mood, and their loved ones feel less distressed. the investigators call this model of care, "early integrated palliative care."
While the investigators know that having palliative care clinicians work closely with the oncology team is helpful for patients and their loved ones, many patients do not have access to these specialists because hospitals and cancer clinics lack enough staff and because some patients and family members live in distant regions that make attending clinic visits difficult and expensive. One way to overcome these barriers is to have patients meet with palliative care clinicians using secure video-conferencing technology.
The purpose of this study is to determine if meeting with a palliative care clinician through video-conferencing is just as beneficial for patients and their families as meeting with a palliative care clinician in person. Specifically, this study will compare these two different strategies for meeting with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month in person at the clinic. The investigators call this strategy "In-person palliative care."
The second strategy is to schedule the participant to meet with the palliative care clinician regularly each month using secure video-conferencing, such as through a smart phone or tablet computer. If the participant do not have this form of technology, the investigators will provide it for the participant. The investigators call this strategy "telehealth palliative care." The primary goals of this study are to learn if telehealth palliative care is just as effective as in-person palliative care for improving quality of life, mood symptoms, and satisfaction with care for patients with advanced lung cancer and their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Patient Eligibility Criteria
- •Diagnosed with advanced non-small cell lung cancer being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 3 (symptomatic and in bed >50% of the day)
- •The ability to read and respond to questions in English or Spanish
- •Receiving primary cancer care at one of the participating sites
- •Age > or = 18 years
- •Lives in a state where their institutions' palliative care clinicians are licensed to practice
- •Caregiver Eligibility Criteria
- •Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week
- •The ability to read and respond to questions in English or Spanish
- •Age > or = 18 years
排除标准
- •Patient Exclusion Criteria
- •Already receiving outpatient palliative care or hospice services
- •Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
- •Caregiver Exclusion Criteria
- •Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
研究组 & 干预措施
Telehealth Palliative Care
- Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment.
- Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks.
- Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician.
(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate with no enrolled caregiver.)
干预措施: Telehealth Palliative Care (Other)
In-person Palliative Care
- Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic.
- In-person palliative care visits will be scheduled on the same day as an oncology visit if possible.
(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate with no enrolled caregiver.)
干预措施: In-person Palliative Care (Other)
结局指标
主要结局
Patient-reported Quality of Life
时间窗: 24 Weeks
Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life.
次要结局
- Patient-reported Satisfaction With Care(24 weeks)
- Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians(48 weeks (or last assessment prior to death if before 48 weeks))
- Proportion of Patient's Palliative Care Visits With a Caregiver Present(24 weeks)
- Length of Stay in Hospice(From hospice enrollment until patient death during study period)
- Caregiver-reported Satisfaction With Care(24 weeks)
研究者
Jennifer Temel, MD
Principal Investigator
Massachusetts General Hospital