Pilot Randomized Controlled Trial of an Artificial Intelligence (AI)-Powered Behavioral Coaching Intervention (Laguna Health) to Promote Post-Hospital Discharge Recovery for Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Feasibility of Laguna Health based on enrollment and intervention use rates
研究概览
简要总结
The overall goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of using a behavioral coaching intervention (Laguna Health) for optimizing post-hospital discharge care in patients with cancer. Patients will be randomly assigned into one of the study groups: the behavioral coaching intervention (Laguna Health) + usual care versus usual care alone.
The Laguna Health intervention has several components:
- Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients identify barriers to post-discharge recovery
- Digital psycho-educational content tailored to the needs of patients with cancer
- Personal healthcare summaries
- Digital content and coaching on behavioral strategies to promote self-efficacy
详细描述
This is a single-center, randomized, controlled research study to test the feasibility, acceptability and preliminary efficacy of Laguna Health for improving post-hospital discharge care in patients with cancer.
Laguna Health is behavioral coaching intervention wherein patients and their caregivers are paired with a Laguna Health recovery coach to promote post-discharge recovery. Additionally, Laguna Health offers patients and their caregivers access to a mobile platform containing psycho-educational content, healthcare summaries, and interactive features such as journaling and task lists.
Participants will be randomized in 1:1 fashion to one of the two study groups: Laguna Health + usual care versus usual care alone, stratified by cancer type and therapy intent (curable solid tumor vs. incurable GI cancer vs. incurable other solid tumor vs hematologic malignancy).
Participants randomly assigned to the Laguna Health group will receive access to the Laguna Health recovery coach and mobile platform for 12 weeks after they are discharged from the hospital.
Participants randomly assigned to the usual care group will receive usual post-hospital discharge care as arranged by their inpatient oncology team. They will not be given access to the Laguna Health intervention.
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
- •(Patients):
- •Adult patients (age > 18 years)
- •Patients with cancer being treated with curative intent per chemotherapy order entry, treatment intent designation and or trial consent forms OR based on documentation in the oncology clinic notes.
- •Patients with cancer being treated with palliative intent (per chemotherapy order entry, treatment intent designation and or trial consent forms OR based on documentation in the oncology clinic notes for those not receiving chemotherapy) who are experiencing their first or second hospitalization for cancer related care or complications.
- •Unplanned or non-elective hospitalization at Massachusetts General Hospital (MGH)
- •Planned discharge to a home environment.
- •Receiving outpatient care at the MGH Cancer Center
- •Access to a smartphone capable of accessing Laguna Health's app on Android or iOS
- •Ability to comprehend, read, and respond to questions in English.
排除标准
- •(Patients):
- •Patients with metastatic or advanced cancer experiencing their third or later hospitalization for cancer related care or complications as these patients likely have advanced disease and require more end-of-life care interventions.
- •Patients with planned discharge to hospice or care facility other than home.
- •Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
- •Caregiver Eligibility
- •Adult (> 18 years) relative or friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with them at least twice per week.
- •Ability to comprehend, read, and respond to questions in English as Laguna Health is only available in English in this proof-of-concept study.
- •Access to a smartphone capable of accessing Laguna Health's app on Android or iOS
- •Note that patients can enroll without an eligible caregiver.
研究组 & 干预措施
Laguna Health Group
- Patient and caregiver participants will have access to Laguna Health coaching and the Laguna Health mobile platform for 12 weeks after discharge from the hospital to a home environment.
- Patient participants will receive usual post-discharge care as arranged by their inpatient and outpatient oncology teams.
- Patient participants will complete study questionnaires to assess their quality of life, symptoms, and psychological outcomes.
- Caregiver participants will complete study questionnaires to assess their quality of life and caregiving burden.
- 10-20 participants will complete exit interviews to ascertain more feedback on the Laguna Health intervention.
干预措施: Laguna Health (Behavioral)
Usual Care
- Participants will receive usual post-hospital discharge care as arranged by their inpatient and outpatient oncology care teams.
- Patient participants will complete study questionnaires to assess their quality of life, symptoms, and psychological outcomes.
- Caregiver participants will complete study questionnaires to assess their quality of life and caregiving burden.
结局指标
主要结局
Feasibility of Laguna Health based on enrollment and intervention use rates
时间窗: Baseline to week-2
Laguna Health will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those patients enrolled and randomized to the intervention arm, 60% engage with the Laguna Health platform during at least 7 weeks of the 12-week post discharge intervention period.
次要结局
- Patient Quality of Life (QOL) (FACT-G)(Baseline to week-24)
- Patient Post-Traumatic Stress Disorder (PTSD) (PCL)(Baseline to week-24)
- Acceptability of Laguna Health for patients with cancer who are discharged from the hospital(Week-12)
- Patient depression symptoms (HADS-Depression subscale)(Baseline to week-24)
- Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital(Week-12)
- Patient symptom burden (ESAS-R)(Baseline to week-24)
- Patient anxiety symptoms (HADS-Anxiety subscale)(Baseline to week-24)
研究者
Tejaswini M. Dhawale, MD
Instructor in Medicine
Massachusetts General Hospital