Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer

Cancer Clinical Trial

— LAGUNA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06004141
• Other study ID #: 23-358
• Status: Terminated
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Laguna Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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