Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer (LAGUNA)

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

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

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Laguna Health

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Laguna Health; Laguna Health is a novel behavioral coaching intervention (Laguna Health) that provides supportive care to patients with cancer who are discharged from the hospital and their caregivers. The intervention includes four components: 1) behavioral coaching with a Laguna Health recovery coach; 2) digital psycho-educational content tailored to the needs of patients with cancer; 3) summary of post-discharge care tasks; and 4) behavioral strategies to promote self-efficacy.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Laguna Health based on enrollment and intervention use rates	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.	Baseline to week-2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Laguna Health for patients with cancer who are discharged from the hospital	Laguna health will be acceptable to patients, defined by at least 80% of patients reporting satisfaction (score > 20, corresponding to scale midpoint) on the 8-item Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32 with the higher number indicating greater satisfaction.	Week-12
Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital	Laguna health will be acceptable to caregivers, defined by at least 80% of caregivers receiving Laguna reporting satisfaction (score > 20, corresponding to scale midpoint) on the 8-item Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32 with the higher number indicating greater satisfaction.	Week-12
Patient Quality of Life (QOL) (FACT-G)	Compare patient QOL as assessed by the Functional Assessment of Cancer Therapy -General (FACT-G) between the two study groups longitudinally. The FACT-G is a 27-item QOL measure that assesses physical, social, emotional, and functional wellbeing during the prior seven days. Scores range from 0-108, with higher scores indicating better QOL.	Baseline to week-24
Patient symptom burden (ESAS-R)	Compare patient symptom burden, as assessed by the Edmonton Symptom Assessment Scale (ESAS-R) between the two study groups. The ESAS-R is a 10-item measure that assesses various symptoms relevant to patients with cancer. The ESAS-R score range 0-100 with higher scores indicating worse symptom burden.	Baseline to week-24
Patient anxiety symptoms (HADS-Anxiety subscale)	Compare anxiety symptoms, as assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), between the study groups. The HADS is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) with higher scores indicating worse anxiety symptoms.	Baseline to week-24
Patient depression symptoms (HADS-Depression subscale)	Compare depression symptoms, as assessed by the self-reported Hospital Anxiety and Depression Scale (HADS) between the study groups. The HADS is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) with high scores indicating worse depression symptoms.	Baseline to week-24
Patient Post-Traumatic Stress Disorder (PTSD) (PCL)	Compare post-traumatic stress symptoms as assessed through the Post-traumatic Stress Disorder Checklist-Civilian Version between the study groups. The PCL is a 17-item PTSD Checklist that evaluates severity of PTSD symptoms. Scores range from 17-85 with higher scores indicating worse PTSD symptoms	Baseline to week-24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient self-efficacy (CASE)	Compare patient self-efficacy, as assessed through the Cancer Self-Efficacy Scale (CASE) between the study groups. The CASE is a commonly utilized measure to assess patients' confidence in managing the impact of their illness. This is a 17-item questionnaire with higher scores (range = 0-170) indicating higher levels of self-efficacy.	Baseline to week-24
Caregiver Quality of Life (CarGOQOL)	Compare caregiver QOL as assessed through the Caregiver Oncology Quality of Life Questionnaire (CarGOQoL) between the study groups. The CARGOQOL is a validated measure of caregiver QOL. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL.	Baseline to week-24
Caregiving burden (CRA)	Compare caregiving burden as assessed through the Caregiver Reaction Assessment (CRA) between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden.	Baseline to week-24
Health Care Utilization	Electronic Health Records (EHR) will be used to assess patient health care utilization including days alive and out of hospital, unplanned readmissions, post-discharge appointment attendance, and emergency department visits during the first 12 and 24 weeks after discharge.	up to week 24

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Laguna Health, Inc
• Investigators: Principal Investigator: Tejaswini Dhawale, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Supportive Care; Neoplasm; Hospitalization; Home care; Transitions of care; Behavioral Coaching
• Other Study ID Numbers: 23-358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Tejaswini Dhawale, MD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No