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Terminated due to withdrawal of funding from Sponsor (Laguna Health)
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| Name | Class |
|---|---|
| Laguna Health, Inc | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laguna Health Group | Experimental |
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| Usual Care | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-efficacy (CASE) | 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. | Baseline to week-24 |
Inclusion Criteria (Patients):
Exclusion Criteria (Patients):
Caregiver Eligibility
Note that patients can enroll without an eligible caregiver.
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| Name | Affiliation | Role |
|---|---|---|
| Tejaswini Dhawale, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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. | 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. | 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. | 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. | 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. | 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 | Baseline to week-24 |
| Caregiver Quality of Life (CarGOQOL) | 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. | Baseline to week-24 |
| Caregiving burden (CRA) | 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. | Baseline to week-24 |
| Health Care Utilization | 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. | up to week 24 |