Early Integrated Telehealth Versus In-Person Palliative C... | NCT03375489

NCT03375489

ID	Type	Description	Link
R-1609-35995	Other Grant/Funding Number	Patient Centered Outcomes Research Institute

Status Module

Sponsor/Collaborators Module

Name	Class
Patient-Centered Outcomes Research Institute	OTHER
Palliative Care Research Cooperative Group	NETWORK

Oversight Module

Description Module

Detailed Description

Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about the cancer diagnosis.

Research has shown that early involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their families cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with the oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they have better symptom control, quality of life, and mood, and their loved ones feel less distressed. the investigators call this model of care, "early integrated palliative care."

While the investigators know that having palliative care clinicians work closely with the oncology team is helpful for patients and their loved ones, many patients do not have access to these specialists because hospitals and cancer clinics lack enough staff and because some patients and family members live in distant regions that make attending clinic visits difficult and expensive. One way to overcome these barriers is to have patients meet with palliative care clinicians using secure video-conferencing technology.

The purpose of this study is to determine if meeting with a palliative care clinician through video-conferencing is just as beneficial for patients and their families as meeting with a palliative care clinician in person. Specifically, this study will compare these two different strategies for meeting with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month in person at the clinic. The investigators call this strategy "In-person palliative care."

The second strategy is to schedule the participant to meet with the palliative care clinician regularly each month using secure video-conferencing, such as through a smart phone or tablet computer. If the participant do not have this form of technology, the investigators will provide it for the participant. The investigators call this strategy "telehealth palliative care." The primary goals of this study are to learn if telehealth palliative care is just as effective as in-person palliative care for improving quality of life, mood symptoms, and satisfaction with care for patients with advanced lung cancer and their families.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telehealth Palliative Care	Experimental	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate with no enrolled caregiver.)	Other: Telehealth Palliative Care
In-person Palliative Care	Active Comparator	Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate with no enrolled caregiver.)	Other: In-person Palliative Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telehealth Palliative Care	Other	Teleconference meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient-reported Quality of Life	Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life.	24 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians	Compare the difference between study groups in the proportion of patients who reported that they discussed their end-of-life care preferences with their clinicians based on a single item from the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ includes a self-report item that assesses whether the patient communicated with their clinicians about their wishes for care if they were dying (i.e., scored dichotomously as "yes vs. no").

Other Outcomes

Measure	Description	Time Frame
Patient-reported Coping Strategies	Compare the difference between study groups in patient-reported coping strategies as measured by the Brief Cope (approach-oriented coping score range: 6-24, with higher scores indicating greater use of approach-oriented coping strategies; avoidant coping score range: 4-16, with higher scores indicating greater use of avoidant coping strategies).	up to 48 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jennifer Temel, MD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
City of Hope

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39259563	Derived	Greer JA, Temel JS, El-Jawahri A, Rinaldi S, Kamdar M, Park ER, Horick NK, Pintro K, Rabideau DJ, Schwamm L, Feliciano J, Chua I, Leventakos K, Fischer SM, Campbell TC, Rabow MW, Zachariah F, Hanson LC, Martin SF, Silveira M, Shoemaker L, Bakitas M, Bauman J, Spoozak L, Grey C, Blackhall L, Curseen K, O'Mahony S, Smith MM, Rhodes R, Cullinan A, Jackson V; REACH PC Investigators. Telehealth vs In-Person Early Palliative Care for Patients With Advanced Lung Cancer: A Multisite Randomized Clinical Trial. JAMA. 2024 Sep 11;332(14):1153-64. doi: 10.1001/jama.2024.13964. Online ahead of print.
35588200

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Telehealth Palliative Care: Patient	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 30, 2024	Jan 3, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Telehealth Palliative Care

FG000633 subjectsNumber represents total patients enrolled and assigned to the Telehealth Palliative Care Group.

FG001617 subjectsNumber represents total patients enrolled and assigned to the In-person Palliative Care Group.

FG002272 subjectsNumber represents total caregivers enrolled and assigned to the Telehealth Palliative Care Group in tandem with the respective patient participant.

FG003276 subjectsNumber represents total caregivers enrolled and assigned to the In-person Palliative Care Group in tandem with the respective patient participant.

The baseline analysis population represents the 1250 patients enrolled in the study (i.e., 633 patients assigned to the Telehealth Palliative Care Group and 617 patients assigned to the In-person Palliative Care Group) as well as the 548 caregivers enrolled in the study (i.e., 272 caregivers assigned to the Telehealth Palliative Care Group and 276 caregivers assigned to the In-person Palliative Care Group in tandem with the respective patient participant).

Arm/Group Information

ID	Title	Description
BG000	Telehealth Palliative Care: Patient	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
BG001	In-person Palliative Care: Patient	Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
BG002	Telehealth Palliative Care: Caregiver	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
BG003	In-person Palliative Care: Caregiver	Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Four caregiver participants in the Telehealth Palliative Care Group and two caregiver participants in the In-person Palliative Care group did not complete the age question on the socio-demographic questionnaire, and therefore their baseline age data are missing.

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000633 ParticipantsBG001617 ParticipantsBG002268 ParticipantsBG003

Sex/Gender, Customized

Count of Participants

Participants

Title	Denominators	Categories
Woman	ParticipantsBG000633 ParticipantsBG001617 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000633 ParticipantsBG001617 ParticipantsBG002

Race/Ethnicity, Customized

Race was collected by self-report, which allowed multiple selections from a predetermined list, including an "other" (write-in) option. Sum of percentages may exceed 100%. In the Telehealth Palliative Care Group, 21 patients and 7 caregivers self-identified as an "other" racial category that was not provided as an option. In the In-person Palliative Care Group, 10 patients and 2 caregivers self-identified as an "other" racial category that was not provided as an option.

Count of Participants

Participants

Title	Denominators	Categories
American Indian or Alaska Native	ParticipantsBG000633 ParticipantsBG001

Region of Enrollment

Number

participants

Title	Denominators	Categories
United States	ParticipantsBG000633 ParticipantsBG001617 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Patient-reported Quality of Life

Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life.

The analysis population represents the numbers of patients in each study group who completed the baseline and 24-week Functional Assessment of Cancer Therapy - Lung Questionnaire.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

24 Weeks

ID	Title	Description
OG000	Telehealth Palliative Care: Patients	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
OG001	In-person Palliative Care: Patients	Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Units	Counts
Participants	OG000305 OG001315

Title

Denominators

Categories

Title	Measurements
	OG00099.7(98.0 to 101.3) OG00197.7(96.1 to 99.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.	Regression, Linear		0.04	The a priori threshold for statistical significance was p<0.05.	Mean Difference (Final Values)	2.0			2-Sided	90	0.1	3.9					Equivalence	Equivalence was established for patient-reported quality of life if the 90% confidence interval for the estimated difference in means was within the margin of ±4 points on the Functional Assessment of Cancer Therapy - Lung Questionnaire.

Secondary

Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians

Compare the difference between study groups in the proportion of patients who reported that they discussed their end-of-life care preferences with their clinicians based on a single item from the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ includes a self-report item that assesses whether the patient communicated with their clinicians about their wishes for care if they were dying (i.e., scored dichotomously as "yes vs. no").

The analysis population represents the numbers of patients in each study group who completed the Prognosis and Treatment Perceptions Questionnaire at least once post baseline up to 48 weeks.

Posted

Count of Participants

Participants

48 weeks (or last assessment prior to death if before 48 weeks)

ID	Title	Description
OG000	Telehealth Palliative Care: Patients	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Secondary

Length of Stay in Hospice

Compare the difference between study groups in the length of stay in hospice (as measured in days) among patients who died during study period per medical record review.

The analysis population represents the numbers of patients in each study group who who died during the study period.

Posted

Least Squares Mean

95% Confidence Interval

days

From hospice enrollment until patient death during study period

ID	Title	Description
OG000	Telehealth Palliative Care: Patients	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
OG001	In-person Palliative Care: Patients	Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Secondary

Proportion of Patient's Palliative Care Visits With a Caregiver Present

Compare the difference between study groups in the proportion of palliative care visits that had a caregiver present as documented by the palliative care clinician using a study visit summary form.

The analysis population represents the numbers of patients in each study group who had any palliative care visits, and the overall number of units analyzed represents the numbers of palliative care visits in each study group through week 24.

Posted

Number

95% Confidence Interval

proportion of visits with a caregiver

24 weeks

Number of Palliative Care Visits

ID	Title	Description
OG000	Telehealth Palliative Care: Patient	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
OG001

Secondary

Patient-reported Satisfaction With Care

Compare the difference between study groups in patient-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire, which has a total scale score range from 0-52 with higher scores indicating greater satisfaction.

The analysis population represents the numbers of patients in each study group who completed the 24-week Satisfaction and Care Delivery Questionnaire.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

24 weeks

ID	Title	Description
OG000	Telehealth Palliative Care: Patient	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
OG001	In-person Palliative Care: Patient

Secondary

Caregiver-reported Satisfaction With Care

Compare the difference between study groups in caregiver-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire (caregiver version), which has a total scale score range from 0-48 with higher scores indicating greater satisfaction.

The analysis population represents the numbers of caregivers in each study group who completed the 24-week Satisfaction and Care Delivery Questionnaire.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

24 weeks

ID	Title	Description
OG000	Telehealth Palliative Care: Caregiver	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
OG001	In-person Palliative Care: Caregiver

Other Pre-specified

Patient-reported Coping Strategies

Compare the difference between study groups in patient-reported coping strategies as measured by the Brief Cope (approach-oriented coping score range: 6-24, with higher scores indicating greater use of approach-oriented coping strategies; avoidant coping score range: 4-16, with higher scores indicating greater use of avoidant coping strategies).

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Patient-reported Prognostic Understanding

Compare the difference between study groups in patient-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which patients rate two items about the goal of their cancer care (i.e., scored dichotomously as either "to cure my cancer" vs any other option) and whether their cancer is curable (i.e., scored dichotomously as "yes or no").

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Caregiver-reported Prognostic Understanding

Compare the difference between study groups in caregiver-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which caregivers rate two items about the goal of their loved one's cancer care (i.e., scored dichotomously as either "to cure his/her cancer" vs any other option) and whether their loved one's cancer is curable (i.e., scored dichotomously as "yes or no").

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Caregiver-reported Quality of Life

Compare the difference between study groups in caregiver-reported quality of life as measured by the Caregiver Oncology Quality of Life Questionnaire, which has a total scale score range of 0-100 with higher scores indicating better quality of life.

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Caregiver-reported Mood Symptoms

Compare the difference between study groups in caregiver-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Patient-reported Mood Symptoms

Compare the difference between study groups in patient-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Patient-reported Depression

Compare the difference between study groups in patient-reported depression as measured by the Patient Health Questionnaire-9, which has a total scale score range from 0-27 with higher scores indicating more significant depression symptoms.

Not Posted

up to 48 weeks

Participants

Other Pre-specified

Health Care Utilization

Compare the difference between study groups in health care utilization as per medical record review of emergency department visits, hospital admissions, chemotherapy administration at the end of life, and hospice service use.

Not Posted

Through study completion, average of 18 month follow up

Participants

Other Pre-specified

Caregiver-reported Quality of Patient Death

Compare the difference between study groups in caregiver-reported quality of patient death as measured by the After Death Assessment, which includes three items that ask the caregiver to rate the quality of the patient's death (from 1 "worst possible" to 10 "best possible"), the degree of physical distress the patient experienced in their last week of life (from 1 "none" to 10 "extremely distressed"), and the degree of psychological distress the patient experienced in their last week of life (from 1 "none" to 10 "extremely upset").

Not Posted

Up to 6 months after patient death during study period

Participants

Other Pre-specified

Patient-reported Quality of Life

Compare the difference between study groups in patient-reported quality of life across all study assessment time points as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better quality of life.

Not Posted

up to 48 weeks

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telehealth Palliative Care: Patients	Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment. Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks. Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.	365	633	0	0	0	0
EG001	In-person Palliative Care: Patients	Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic. In-person palliative care visits will be scheduled on the same day as an oncology visit if possible. (Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.) In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.	368	617	0	0	0	0

ID	Term
D008175	Lung Neoplasms

ParticipantsBG0041792

ParticipantsBG003276

ParticipantsBG0041798

ParticipantsBG003276

ParticipantsBG0041798

ParticipantsBG002272

ParticipantsBG003276

ParticipantsBG0041798

ParticipantsBG003276

ParticipantsBG0041798

Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic.
In-person palliative care visits will be scheduled on the same day as an oncology visit if possible.

(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.)

In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic.
In-person palliative care visits will be scheduled on the same day as an oncology visit if possible.

(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.)

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases