Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004141
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2023-08-16
Brief Title:
Behavioral Coaching Intervention Laguna Health for Patients With Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to withdrawal of funding from Sponsor Laguna Health
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAGUNA
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
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None