Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer

NCT ID: NCT06004141

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-01-29

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Laguna Health

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laguna Health, Inc

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tejaswini M. Dhawale, MD

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tejaswini Dhawale, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

23-358

Identifier Type: -

Identifier Source: org_study_id