NCT03154190 · REGISTRY CONDITION SEARCH

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2025-01-24

This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Emergency Department Visits (Chart Review)

→

outcome · POSTED

Number of Hospitalization Visits (Chart Review)

→

outcome · POSTED

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

→

outcome · POSTED

Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.

→

outcome · POSTED

Mean Emergency Department Visits (Chart Review)

→

outcome · POSTED

Number of People With Emergency Department Visit (Chart Review)

→

outcome · POSTED

Hospitalization Visits (Chart Review)

→

outcome · POSTED

Number of Patients With Hospital Use (Chart Review)

→

outcome · POSTED

Hospice Consult (Chart Review)

→

outcome · POSTED

Hospice Consult (Chart Review)

→

outcome · POSTED

Hospice Consult (Chart Review)

→

outcome · POSTED

Palliative Care Consult (Chart Review)

→

outcome · POSTED

Palliative Care Consult (Chart Review)

→

outcome · POSTED

Palliative Care Consult (Chart Review)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Newly diagnosed patients for the following conditions * Colon cancer stage III and IV * Rectal cancer stage II, III, IV * Glioblastoma multiforme (brain) -- no stage * Non-small cell lung cancer stage IIIA, IIIB, IV * Small cell lung cancer, limited stage and extensive stage * Castration-resistant prostate cancer * Head and neck cancer stage III and IV * Gastric cancer stage III and IV * Esophageal cancer stage III and IV * Pancreatic cancer stage II, III, IV * Renal cell carcinoma, stage IV * Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy * Sarcoma, stage IV * Bladder carcinoma, stage IV * Acute myeloid leukemia * Melanoma, stage III and IV * Ovarian cancer, stage III and IV * High grade myelodysplastic syndrome (MDS) * Any patient with recurrent or progressive cancer * Patients must have the ability to understand and willingness to sign a written informed consent document * Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care Exclusion Criteria: * Patients must have capacity to consent * Pregnant patients are excluded
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive usual care.
intervention Names
Other: Best Practice
Other: Laboratory Biomarker Analysis
Other: Survey Administration
label
Arm A (usual care)
type
ACTIVE_COMPARATOR
description
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.
intervention Names
Other: Laboratory Biomarker Analysis
Procedure: Supportive Care
Other: Survey Administration
label
Arm B (health care coach support)
type
EXPERIMENTAL

interventions

arm Group Labels
Arm A (usual care)
description
Receive usual care
name
Best Practice
other Names
standard of care
standard therapy
type
OTHER
arm Group Labels
Arm A (usual care)
Arm B (health care coach support)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Arm B (health care coach support)
description
Undergo health care coach support
name
Supportive Care
other Names
Supportive Therapy
Symptom Management
Therapy, Supportive
type
PROCEDURE
arm Group Labels
Arm A (usual care)
Arm B (health care coach support)
description
Ancillary studies
name
Survey Administration
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

HEALTH_SERVICES_RESEARCH

Enrollment

count: 128
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Emergency Department Visits (Chart Review)
time Frame
6 months after patient enrollment
description
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.
measure
Number of Hospitalization Visits (Chart Review)
time Frame
6 months after patient enrollment

secondary Outcomes

description
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."
measure
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
time Frame
Change in patient satisfaction with care and decision making from baseline to 6 and 12 months
description
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."
measure
Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.
time Frame
Change in patient satisfaction with care from baseline to 6 and 12 months
description
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.
measure
Mean Emergency Department Visits (Chart Review)
time Frame
12 months after patient enrollment
description
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.
measure
Number of People With Emergency Department Visit (Chart Review)
time Frame
30 days prior to death
description
Hospital 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 hospitalization use between study arms.
measure
Hospitalization Visits (Chart Review)
time Frame
12 months after patient enrollment
description
Number of patients with hospital 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 proportion of people with hospitalization use between study arms in the 30 days before death.
measure
Number of Patients With Hospital Use (Chart Review)
time Frame
30 days prior to death
description
Hospice 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 hospice use between study arms.
measure
Hospice Consult (Chart Review)
time Frame
6 months after patient enrollment
description
Hospice 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 hospice use between study arms.
measure
Hospice Consult (Chart Review)
time Frame
12 months after patient enrollment
description
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.
measure
Hospice Consult (Chart Review)
time Frame
30 days prior to death
description
Palliative Care consult 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 palliative care use between study arms.
measure
Palliative Care Consult (Chart Review)
time Frame
6 months after patient enrollment
description
Palliative Care consult 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 palliative care use between study arms.
measure
Palliative Care Consult (Chart Review)
time Frame
12 months after patient enrollment
description
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms.
measure
Palliative Care Consult (Chart Review)
time Frame
30 days prior to death

Full study description

brief Summary: This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.
detailed Description: PRIMARY OBJECTIVES: I. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities. SECONDARY OBJECTIVES: I. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive usual care. ARM B: 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. After completion of study, patients are followed up for 6 months.

Source references

references

citation
Patel MI, Kapphahn K, Dewland M, Aguilar V, Sanchez B, Sisay E, Murillo A, Smith K, Park DJ. Effect of a Community Health Worker Intervention on Acute Care Use, Advance Care Planning, and Patient-Reported Outcomes Among Adults With Advanced Stages of Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1139-1148. doi: 10.1001/jamaoncol.2022.1997.
pmid
35771552
type
DERIVED
citation
Patel MI, Aguilar V, Sanchez B, Sisay E, Park DJ. Health care coach support to assist with advance care planning and symptom management -A randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106617. doi: 10.1016/j.cct.2021.106617. Epub 2021 Nov 5.
pmid
34749008
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-2350e8a9b6c6a3313b29
requested nct id
NCT03154190
primary nct id
NCT03154190
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
payload sha256
b463dc7aa0b71068932cc989fd545154e36919a53d043442b6ebb1b2194f3b7b
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-2350e8a9b6c6a3313b29
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT03154190
occurrences
context exact
NCT03154190
end
11
exact text
NCT03154190
start
0
offset unit
unicode_code_points
query cond
Small Intestine Cancer
query disease state id
ds-small-intestine-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
source file sha256
69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
source json pointer
/studies/65/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
fea620c44bf8b03564b7e7e18be8e60074b3b326bde00b3ecc2319fcf2aafde1
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-52e4b3ebf34780523f61
requested nct id
NCT03154190
primary nct id
NCT03154190
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Ovarian+Germ+Cell+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
payload sha256
01a008c15869a4991962bad88093705d50ead35df7324e6aac181711035cb438
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-52e4b3ebf34780523f61
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT03154190
occurrences
context exact
NCT03154190
end
11
exact text
NCT03154190
start
0
offset unit
unicode_code_points
query cond
Ovarian Germ Cell Tumors
query disease state id
ds-ovarian-germ-cell-tumors
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-ovarian-germ-cell-tumors-000.json
source file sha256
359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
source json pointer
/studies/50/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
fea620c44bf8b03564b7e7e18be8e60074b3b326bde00b3ecc2319fcf2aafde1
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Ovarian+Germ+Cell+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice