Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer

NCT06004141 | Terminated DMC

• 1 other identifier: 23-358
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Keywords

Transitions of care; Hospitalization; Quality of Life; Behavioral Coaching; Home care; Neoplasm; Supportive Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Acceptability of Laguna Health for patients with cancer who are discharged from the hospital

  Week-12

• Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital

  Week-12

• Patient Quality of Life (QOL) (FACT-G)

  Baseline to week-24

• Patient symptom burden (ESAS-R)

  Baseline to week-24

• Patient anxiety symptoms (HADS-Anxiety subscale)

  Baseline to week-24

Other Outcomes (4)

• Patient self-efficacy (CASE)

  Baseline to week-24

• Caregiver Quality of Life (CarGOQOL)

  Baseline to week-24

• Caregiving burden (CRA)

  Baseline to week-24

Study Arms (2)

Laguna Health Group

EXPERIMENTAL

* 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

Usual Care

NO INTERVENTION

* 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.

Interventions

Laguna Health 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.

Laguna Health Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Laguna Health, Inc: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tejaswini Dhawale, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: August 30, 2023
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)