Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer

Massachusetts General Hospital18 enrolled

Overview

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

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

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline to week-2

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.