CancerLAGUNANCT06004141
Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer
A study testing Laguna Health in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Laguna Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
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
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:
- Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients identify barriers to post-discharge recovery
- Digital psycho-educational content tailored to the needs of patients with cancer
- Personal healthcare summaries
- Digital content and coaching on behavioral strategies to promote self-efficacy
Read the 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
- Being tested
- Laguna Health
- Keywords
- Transitions of care, Hospitalization, Quality of Life, Behavioral Coaching, Home care, Neoplasm, Supportive Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laguna HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week-2
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to week-24
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.
Measured: Baseline to week-24
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.
Measured: Baseline to week-24
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.
Measured: Baseline to week-24
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
Measured: Baseline to week-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start30 Aug 2023
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Why it stopped: Terminated due to withdrawal of funding from Sponsor (Laguna Health)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laguna Health, Inc
- Responsible party
- Principal investigator, Tejaswini M. Dhawale, MD, Massachusetts General Hospital
- Investigators
- Tejaswini Dhawale, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004141
- Sponsor's protocol ID
- 23-358
- Acronym
- LAGUNA
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Tejaswini Dhawale, MD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06004141
- Acronym / sponsor ID
- LAGUNA / 23-358
- Conditions
- Cancer
- Keywords
- Transitions of care, Hospitalization, Quality of Life, Behavioral Coaching, Home care, Neoplasm, Supportive Care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to withdrawal of funding from Sponsor (Laguna Health)
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Laguna Health, Inc
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients identify barriers to post-discharge recovery
- Digital psycho-educational content tailored to the needs of patients with cancer
- Personal healthcare summaries
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laguna Health Group | Experimental | Behavioral: Laguna Health* 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laguna HealthLaguna 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. | Behavioural | Laguna Health Group |
Primary outcome
Feasibility of Laguna Health based on enrollment and intervention use rates
Time frame: Baseline to week-2
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.
7 secondary outcomes
Acceptability of Laguna Health for patients with cancer who are discharged from the hospital
Time frame: Week-12
Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital
Time frame: Week-12
Patient Quality of Life (QOL) (FACT-G)
Time frame: Baseline to week-24
Patient symptom burden (ESAS-R)
Time frame: Baseline to week-24
Patient anxiety symptoms (HADS-Anxiety subscale)
Time frame: Baseline to week-24
Patient depression symptoms (HADS-Depression subscale)
Time frame: Baseline to week-24
Patient Post-Traumatic Stress Disorder (PTSD) (PCL)
Time frame: Baseline to week-24
Results and safety
The study was stopped early (reason given: Terminated due to withdrawal of funding from Sponsor (Laguna Health)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Tejaswini Dhawale, MD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejaswini Dhawale, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laguna Health in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to withdrawal of funding from Sponsor (Laguna Health)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Laguna Health based on enrollment and intervention use rates (time frame: Baseline to week-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.