TriangleNCT03154190 · STUDY IN CONTEXT
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Mean emergency department visits for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of emergency department visits between study arms.
Mean Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of hospitalizations between the two study arms.
Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at baseline, 6 months, and 12 months. Satisfaction with Decision was assessed using the Satisfaction with Decision scale, which measured rating of decision-making. Questions were assessed with responses on a scale of "strongly disagree," "disagree," "neither agree nor disagree," "agree," or "strongly agree." Results are expressed as proportion of participants who responded "strongly agree."
Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at baseline, 6 months, and 12 months. Overall Health and Overall Mental or Emotional health was assessed using the Consumer Assessment of Health Care Providers and Systems-Clinician and Group Survey version 2.0 (cite) questions #26, which measured rating of overall health with responses, "excellent," "very good," "fair," or "poor." Questions were assessed with responses "never", "sometimes," "usually," or "always," or care rated as "worst," "fair," good", or "best." Results are expressed as proportion of participants who responded "always", or "best care."
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.
Number of people with Emergency Department use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of the number of people with emergency department visits between study arms.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- trial label
- Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0000
- source section id
- NCT03154190-om-0000
- source outcome index
- 0
- endpoint
- Number of Emergency Department Visits (Chart Review)
- endpoint definition
- Mean emergency department visits for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of emergency department visits between study arms.
- time origin
- 6 months after patient enrollment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0001
- source section id
- NCT03154190-om-0001
- source outcome index
- 1
- endpoint
- Number of Hospitalization Visits (Chart Review)
- endpoint definition
- Mean Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of hospitalizations between the two study arms.
- time origin
- 6 months after patient enrollment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0002
- source section id
- NCT03154190-om-0002
- source outcome index
- 2
- endpoint
- Change in Patient Satisfaction With Care and Decision Making Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction With Decision Scale
- endpoint definition
- Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at baseline, 6 months, and 12 months. Satisfaction with Decision was assessed using the Satisfaction with Decision scale, which measured rating of decision-making. Questions were assessed with responses on a scale of "strongly disagree," "disagree," "neither agree nor disagree," "agree," or "strongly agree." Results are expressed as proportion of participants who responded "strongly agree."
- time origin
- Change in patient satisfaction with care and decision making from baseline to 6 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who completed the survey at each respective time point are included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0003
- source section id
- NCT03154190-om-0003
- source outcome index
- 3
- endpoint
- Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.
- endpoint definition
- Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at baseline, 6 months, and 12 months. Overall Health and Overall Mental or Emotional health was assessed using the Consumer Assessment of Health Care Providers and Systems-Clinician and Group Survey version 2.0 (cite) questions #26, which measured rating of overall health with responses, "excellent," "very good," "fair," or "poor." Questions were assessed with responses "never", "sometimes," "usually," or "always," or care rated as "worst," "fair," good", or "best." Results are expressed as proportion of participants who responded "always", or "best care."
- time origin
- Change in patient satisfaction with care from baseline to 6 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who completed the survey at each respective time point are included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0004
- source section id
- NCT03154190-om-0004
- source outcome index
- 4
- endpoint
- Mean Emergency Department Visits (Chart Review)
- endpoint definition
- Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.
- time origin
- 12 months after patient enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0005
- source section id
- NCT03154190-om-0005
- source outcome index
- 5
- endpoint
- Number of People With Emergency Department Visit (Chart Review)
- endpoint definition
- Number of people with Emergency Department use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of the number of people with emergency department visits between study arms.
- time origin
- 30 days prior to death
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Usual Care)
- regimen
- Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (Health Care Coach Support)
- regimen
- Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Laboratory Biomarker Analysis: Correlative studies Supportive Care: Undergo health care coach support Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A (Usual Care)
- regimen
- Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B (Health Care Coach Support)
- regimen
- Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Laboratory Biomarker Analysis: Correlative studies Supportive Care: Undergo health care coach support Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Usual Care)
- regimen
- Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B (Health Care Coach Support)
- regimen
- Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Laboratory Biomarker Analysis: Correlative studies Supportive Care: Undergo health care coach support Survey Administration: Ancillary studies
- analyzed count
- 51
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (Usual Care)
- regimen
- Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B (Health Care Coach Support)
- regimen
- Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Laboratory Biomarker Analysis: Correlative studies Supportive Care: Undergo health care coach support Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A (Usual Care)
- regimen
- Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B (Health Care Coach Support)
- regimen
- Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Laboratory Biomarker Analysis: Correlative studies Supportive Care: Undergo health care coach support Survey Administration: Ancillary studies
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm A (Usual Care)
- regimen
- Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm B (Health Care Coach Support)
- regimen
- Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Laboratory Biomarker Analysis: Correlative studies Supportive Care: Undergo health care coach support Survey Administration: Ancillary studies
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03154190-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- harm key
- EG000
- source section id
- NCT03154190-ae
- event group key
- EG000
- event group label
- Arm A (Usual Care)
- serious affected
- 0
- serious at risk
- 64
- other affected
- 0
- other at risk
- 64
- frequency threshold
- 5
- collection period
- 1 year
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer-ogivri-f3a154e8
- nct id
- NCT03154190
- harm key
- EG001
- source section id
- NCT03154190-ae
- event group key
- EG001
- event group label
- Arm B (Health Care Coach Support)
- serious affected
- 0
- serious at risk
- 64
- other affected
- 0
- other at risk
- 64
- frequency threshold
- 5
- collection period
- 1 year
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice