xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004141</url>
    </required_header>
    <id_info>
      <org_study_id>23-358</org_study_id>
      <nct_id>NCT06004141</nct_id>
    </id_info>
    <brief_title>Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer</brief_title>
    <acronym>LAGUNA</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Laguna Health, Inc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall goal of this study is to examine the feasibility, acceptability, and preliminary&#xD;
        efficacy of using a behavioral coaching intervention (Laguna Health) for optimizing&#xD;
        post-hospital discharge care in patients with cancer. Patients will be randomly assigned into&#xD;
        one of the study groups: the behavioral coaching intervention (Laguna Health) + usual care&#xD;
        versus usual care alone.&#xD;
  &#xD;
        The Laguna Health intervention has several components:&#xD;
  &#xD;
          1. Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients&#xD;
             identify barriers to post-discharge recovery&#xD;
  &#xD;
          2. Digital psycho-educational content tailored to the needs of patients with cancer&#xD;
  &#xD;
          3. Personal healthcare summaries&#xD;
  &#xD;
          4. Digital content and coaching on behavioral strategies to promote self-efficacy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, randomized, controlled research study to test the feasibility,&#xD;
        acceptability and preliminary efficacy of Laguna Health for improving post-hospital discharge&#xD;
        care in patients with cancer.&#xD;
  &#xD;
        Laguna Health is behavioral coaching intervention wherein patients and their caregivers are&#xD;
        paired with a Laguna Health recovery coach to promote post-discharge recovery. Additionally,&#xD;
        Laguna Health offers patients and their caregivers access to a mobile platform containing&#xD;
        psycho-educational content, healthcare summaries, and interactive features such as journaling&#xD;
        and task lists.&#xD;
  &#xD;
        Participants will be randomized in 1:1 fashion to one of the two study groups: Laguna Health&#xD;
        + usual care versus usual care alone, stratified by cancer type and therapy intent (curable&#xD;
        solid tumor vs. incurable GI cancer vs. incurable other solid tumor vs hematologic&#xD;
        malignancy).&#xD;
  &#xD;
        Participants randomly assigned to the Laguna Health group will receive access to the Laguna&#xD;
        Health recovery coach and mobile platform for 12 weeks after they are discharged from the&#xD;
        hospital.&#xD;
  &#xD;
        Participants randomly assigned to the usual care group will receive usual post-hospital&#xD;
        discharge care as arranged by their inpatient oncology team. They will not be given access to&#xD;
        the Laguna Health intervention.&#xD;
  &#xD;
        In both groups, participants are asked to complete questionnaires at baseline, weeks 6, weeks&#xD;
        12 and weeks 24 after enrolling in the study.&#xD;
  &#xD;
        It is expected that 80 patients and at most 80 caregivers will take part in this study.&#xD;
  &#xD;
        Laguna Health, Inc. is supporting this research study by providing funding.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of Laguna Health based on enrollment and intervention use rates</measure>
      <time_frame>Baseline to week-2</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Laguna Health for patients with cancer who are discharged from the hospital</measure>
      <time_frame>Week-12</time_frame>
      <description>Laguna health will be acceptable to patients, defined by at least 80% of patients reporting satisfaction (score &gt; 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital</measure>
      <time_frame>Week-12</time_frame>
      <description>Laguna health will be acceptable to caregivers, defined by at least 80% of caregivers receiving Laguna reporting satisfaction (score &gt; 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Quality of Life (QOL) (FACT-G)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient symptom burden (ESAS-R)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient anxiety symptoms (HADS-Anxiety subscale)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient depression symptoms (HADS-Depression subscale)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Post-Traumatic Stress Disorder (PTSD) (PCL)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>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</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient self-efficacy (CASE)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>Compare patient self-efficacy, as assessed through the Cancer Self-Efficacy Scale (CASE) between the study groups. The CASE is a commonly utilized measure to assess patients' confidence in managing the impact of their illness. This is a 17-item questionnaire with higher scores (range = 0-170) indicating higher levels of self-efficacy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Quality of Life (CarGOQOL)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>Compare caregiver QOL as assessed through the Caregiver Oncology Quality of Life Questionnaire (CarGOQoL) between the study groups. The CARGOQOL is a validated measure of caregiver QOL. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiving burden (CRA)</measure>
      <time_frame>Baseline to week-24</time_frame>
      <description>Compare caregiving burden as assessed through the Caregiver Reaction Assessment (CRA) between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden.</description>
    </other_outcome>
    <other_outcome>
      <measure>Health Care Utilization</measure>
      <time_frame>up to week 24</time_frame>
      <description>Electronic Health Records (EHR) will be used to assess patient health care utilization including days alive and out of hospital, unplanned readmissions, post-discharge appointment attendance, and emergency department visits during the first 12 and 24 weeks after discharge.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Laguna Health Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Patient participants will receive usual post-discharge care as arranged by their inpatient and outpatient oncology teams.&#xD;
  Patient participants will complete study questionnaires to assess their quality of life, symptoms, and psychological outcomes.&#xD;
  Caregiver participants will complete study questionnaires to assess their quality of life and caregiving burden.&#xD;
  10-20 participants will complete exit interviews to ascertain more feedback on the Laguna Health intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will receive usual post-hospital discharge care as arranged by their inpatient and outpatient oncology care teams.&#xD;
  Patient participants will complete study questionnaires to assess their quality of life, symptoms, and psychological outcomes.&#xD;
  Caregiver participants will complete study questionnaires to assess their quality of life and caregiving burden.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Laguna Health</intervention_name>
      <description>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.</description>
      <arm_group_label>Laguna Health Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Patients):&#xD;
  &#xD;
            -  Adult patients (age &gt; 18 years)&#xD;
  &#xD;
            -  Patients with cancer being treated with curative intent per chemotherapy order entry,&#xD;
               treatment intent designation and or trial consent forms OR based on documentation in&#xD;
               the oncology clinic notes.&#xD;
  &#xD;
            -  Patients with cancer being treated with palliative intent (per chemotherapy order&#xD;
               entry, treatment intent designation and or trial consent forms OR based on&#xD;
               documentation in the oncology clinic notes for those not receiving chemotherapy) who&#xD;
               are experiencing their first or second hospitalization for cancer related care or&#xD;
               complications.&#xD;
  &#xD;
            -  Unplanned or non-elective hospitalization at Massachusetts General Hospital (MGH)&#xD;
  &#xD;
            -  Planned discharge to a home environment.&#xD;
  &#xD;
            -  Receiving outpatient care at the MGH Cancer Center&#xD;
  &#xD;
            -  Access to a smartphone capable of accessing Laguna Health's app on Android or iOS&#xD;
  &#xD;
            -  Ability to comprehend, read, and respond to questions in English.&#xD;
  &#xD;
          Exclusion Criteria (Patients):&#xD;
  &#xD;
            -  Patients with metastatic or advanced cancer experiencing their third or later&#xD;
               hospitalization for cancer related care or complications as these patients likely have&#xD;
               advanced disease and require more end-of-life care interventions.&#xD;
  &#xD;
            -  Patients with planned discharge to hospice or care facility other than home.&#xD;
  &#xD;
            -  Patients with acute or unstable psychiatric or cognitive conditions which the treating&#xD;
               clinicians believes prohibits informed consent or compliance with study procedures&#xD;
  &#xD;
          Caregiver Eligibility&#xD;
  &#xD;
            -  Adult (&gt; 18 years) relative or friend of a patient who agrees to participate in the&#xD;
               study whom the patient identified as living with them or having in-person contact with&#xD;
               them at least twice per week.&#xD;
  &#xD;
            -  Ability to comprehend, read, and respond to questions in English as Laguna Health is&#xD;
               only available in English in this proof-of-concept study.&#xD;
  &#xD;
            -  Access to a smartphone capable of accessing Laguna Health's app on Android or iOS&#xD;
  &#xD;
          Note that patients can enroll without an eligible caregiver.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tejaswini Dhawale, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tejaswini Dhawale, MD</last_name>
      <phone>617-726-2000</phone>
      <email>tdhawale@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Areej El-Jawahri</last_name>
      <phone>617-726-2000</phone>
      <email>ael-jawahri@partners.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Massachusetts General Hospital Cancer Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tejaswini Dhawale, MD</last_name>
        <phone>617-726-2000</phone>
        <email>tdhawale@mgh.harvard.edu</email>
      </contact>
      <contact_backup>
        <last_name>Areej El-Jawahri, MD</last_name>
        <phone>617-726-2000</phone>
        <phone_ext>Dhawale</phone_ext>
        <email>tdhawale@mgh.harvard.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Tejaswini Dhawale, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Tejaswini M. Dhawale, MD</investigator_full_name>
      <investigator_title>Instructor in Medicine</investigator_title>
    </responsible_party>
    <keyword>Transitions of care</keyword>
    <keyword>Hospitalization</keyword>
    <keyword>Quality of Life</keyword>
    <keyword>Behavioral Coaching</keyword>
    <keyword>Home care</keyword>
    <keyword>Neoplasm</keyword>
    <keyword>Supportive Care</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
      <ipd_url>http://www.partners.org/innovation</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004141
  org study id: 23-358
  nct id: NCT06004141
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Feasibility of Laguna Health based on enrollment and intervention use rates
  time frame: Baseline to week-2
  description: 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.
  measure: Acceptability of Laguna Health for patients with cancer who are discharged from the hospital
  time frame: Week-12
  description: 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.
  measure: Acceptability of Laguna Health for caregivers of patients patients with cancer who are discharged from the hospital
  time frame: Week-12
  description: 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.
  measure: Patient Quality of Life (QOL) (FACT-G)
  time frame: Baseline to week-24
  description: 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.
  measure: Patient symptom burden (ESAS-R)
  time frame: Baseline to week-24
  description: 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.
  measure: Patient anxiety symptoms (HADS-Anxiety subscale)
  time frame: Baseline to week-24
  description: 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.
  measure: Patient depression symptoms (HADS-Depression subscale)
  time frame: Baseline to week-24
  description: 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.
  measure: Patient Post-Traumatic Stress Disorder (PTSD) (PCL)
  time frame: Baseline to week-24
  description: 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
  measure: Patient self-efficacy (CASE)
  time frame: Baseline to week-24
  description: Compare patient self-efficacy, as assessed through the Cancer Self-Efficacy Scale (CASE) between the study groups. The CASE is a commonly utilized measure to assess patients' confidence in managing the impact of their illness. This is a 17-item questionnaire with higher scores (range = 0-170) indicating higher levels of self-efficacy.
  measure: Caregiver Quality of Life (CarGOQOL)
  time frame: Baseline to week-24
  description: Compare caregiver QOL as assessed through the Caregiver Oncology Quality of Life Questionnaire (CarGOQoL) between the study groups. The CARGOQOL is a validated measure of caregiver QOL. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL.
  measure: Caregiving burden (CRA)
  time frame: Baseline to week-24
  description: Compare caregiving burden as assessed through the Caregiver Reaction Assessment (CRA) between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden.
  measure: Health Care Utilization
  time frame: up to week 24
  description: Electronic Health Records (EHR) will be used to assess patient health care utilization including days alive and out of hospital, unplanned readmissions, post-discharge appointment attendance, and emergency department visits during the first 12 and 24 weeks after discharge.
  arm group label: Laguna Health Group
  arm group type: Experimental
  description: 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.
  arm group label: Usual Care
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Laguna Health
  description: 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.
  arm group label: Laguna Health Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tejaswini Dhawale, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Tejaswini Dhawale, MD
  phone: 617-726-2000
  email: tdhawale@mgh.harvard.edu
  last name: Areej El-Jawahri
  phone: 617-726-2000
  email: ael-jawahri@partners.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Tejaswini M. Dhawale, MD
  investigator title: Instructor in Medicine
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
  ipd url: http://www.partners.org/innovation