Clinical trial NCT06004141: Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Transitions of care
Hospitalization
Quality of Life
Behavioral Coaching
Home care
Neoplasm
Supportive Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Laguna Health, Inc
First posted: 2023-08-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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:

1. Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients identify barriers to post-discharge recovery
2. Digital psycho-educational content tailored to the needs of patients with cancer
3. Personal healthcare summaries
4. Digital content and coaching on behavioral strategies to promote self-efficacy

Detailed description: 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.

In both groups, participants are asked to complete questionnaires at baseline, weeks 6, weeks 12 and weeks 24 after enrolling in the study.

It is expected that 80 patients and at most 80 caregivers will take part in this study.

Laguna Health, Inc. is supporting this research study by providing funding.

Eligibility criteria: Inclusion Criteria (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.

Exclusion Criteria (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.

Primary outcomes:
measure: Feasibility of Laguna Health based on enrollment and intervention use rates
timeFrame: Baseline to week-2
Secondary outcomes:
measure: Acceptability of Laguna Health for patients with cancer who are discharged from the hospital
timeFrame: Week-12
measure: Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital
timeFrame: Week-12
measure: Patient Quality of Life (QOL) (FACT-G)
timeFrame: Baseline to week-24
measure: Patient symptom burden (ESAS-R)
timeFrame: Baseline to week-24
measure: Patient anxiety symptoms (HADS-Anxiety subscale)
timeFrame: Baseline to week-24
measure: Patient depression symptoms (HADS-Depression subscale)
timeFrame: Baseline to week-24
measure: Patient Post-Traumatic Stress Disorder (PTSD) (PCL)
timeFrame: Baseline to week-24
Other outcomes:
measure: Patient self-efficacy (CASE)
timeFrame: Baseline to week-24
measure: Caregiver Quality of Life (CarGOQOL)
timeFrame: Baseline to week-24
measure: Caregiving burden (CRA)
timeFrame: Baseline to week-24
measure: Health Care Utilization
timeFrame: up to week 24
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Tejaswini Dhawale, MD
role: PRINCIPAL_INVESTIGATOR
References: