Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02349412
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 405
• Locations: 23
• Arms: 2
• Actual Duration (Months): 51.4
• Patients Per Site: 17.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent. The palliative care services provided to patients randomized to the intervention will be provided by board-certified physicians and/or advanced practice nurses and will focus on the following areas: (1) developing and maintaining the therapeutic relationship with the patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing support and reinforcement of coping with advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care planning.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer; Anxiety Disorder; Depression; Small Cell Lung Cancer; Extrahepatic Bile Duct Cancer; Malignant Mesothelioma; Pancreatic Cancer; Esophageal Cancer; Gastric Cancer; Non-small Cell Lung Cancer	Other: Early palliative care	Phase 3

Detailed Description

There will be about 400 patients enrolled in this intervention study and there will be about 300 family caregivers enrolled as well. This study will consist of two study groups as previously described. The effects of the early involvement of the palliative care team will be compared to the usual approach of receiving care mostly from the cancer treatment team. The stratification factors include tumor type (lung vs. esophageal/gastric vs. hepatic/biliary/pancreatic) and family care giver participation (yes vs. no). Patients will be on this study for as long as they receive care. Institutions must have an outpatient palliative care clinic that meets the study site requirements as defined in the protocol. The outpatient clinic leadership must include a physician and/or advanced practice nurses board certified in palliative care. The primary and secondary endpoints are described below.

Primary Endpoint:

To determine the efficacy of early integrated palliative care on patient reported quality of life at 12 weeks using the FACT in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer

Secondary Endpoints:

• To determine the efficacy of early integrated palliative care on other patient reported outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints defined in the protocol

• To determine the efficacy of early integrated palliative care on family caregiver reported outcomes in those newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints defined in the protocol

• To assess the impact of early integrated palliative care on the quality of end-of-life care and resource utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by assessing the endpoints defined in the protocol

• To determine concordance between patient and family caregiver report of prognosis/ curability

Study Design

• Study Type: Interventional
• Actual Enrollment: 405 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Incurable Lung or Non-Colorectal Gastrointestinal Malignancies
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jul 3, 2017
• Actual Study Completion Date: Jul 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Other: Early palliative care
Experimental: Arm 2 Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.	Other: Early palliative care

Outcome Measures

Primary Outcome Measures

1. Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) [Up to 12 weeks]

   Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.

Secondary Outcome Measures

1. Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) [Up to 24 weeks]

   Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL.

2. Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression [Up to 12 weeks]

   Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms.

3. Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety [Up to 12 weeks]

   Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms.

4. Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire [Up to 12 weeks]

   Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: "Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying?" responses at Week-12 are reported below.

5. Change in QOL on the SF-36 Over Time [Up to 3 years]

6. Rate of Referral, Enrollment and Length of Stay on Hospice [Up to 3 years]

7. Location of Death [Up to 3 years]

8. Number of Hospital and Intensive Care Unit (ICU) Admissions and Days [Up to 3 years]

9. Chemotherapy and Radiation Administration [Up to 3 years]

10. Overall Survival [Up to 3 years]

11. Concordance Between Patient and Family Caregiver Report of Prognosis/Curability [Up to 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Study Patient Participant Eligibility Requirements:

1. Documentation of Disease: Confirmed advanced lung cancer (NSCLC, small cell lung cancer, or mesothelioma) or non-colorectal GI cancer (esophageal, gastric, hepatic, biliary, or pancreatic) not being treated with curative intent.

2. Informed of diagnosis of incurable disease within the previous 8 weeks.

3. Age ≥ 18 years

4. ECOG Performance Status 0-2

5. Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.

6. Planning to receive all medical care for cancer at the enrolling institution.

7. Participants must be under the care of an oncologist, but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies.

Study Family Caregiver Participant Eligibility Requirements:

1. Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits.

2. Family caregiver must live with the patient or have in-person contact with him or her at least twice per week.

3. Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.

4. Age ≥ 18 years

Note: An eligible patient may participate in this trial without an eligible family caregiver being registered.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
2	Queen's Medical Center	Honolulu	Hawaii	United States	96813
3	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
4	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois	United States	60201
5	NorthShore University HealthSystem-Glenbrook Hospital	Glenview	Illinois	United States	60026
6	NorthShore University HealthSystem-Highland Park Hospital	Highland Park	Illinois	United States	60035
7	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
8	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
9	Mercy Health Saint Mary's	Grand Rapids	Michigan	United States	49503
10	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
11	Mayo Clinic	Rochester	Minnesota	United States	55905
12	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
13	Regions Hospital	Saint Paul	Minnesota	United States	55101
14	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
15	North Shore-LIJ Health System/Center for Advanced Medicine	New Hyde Park	New York	United States	11040
16	Columbia University/Herbert Irving Cancer Center	New York	New York	United States	10032
17	Duke University Medical Center	Durham	North Carolina	United States	27710
18	Altru Cancer Center	Grand Forks	North Dakota	United States	58201
19	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
20	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
21	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
22	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
23	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Jennifer Temel, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 15, 2016

More Information

Additional Information:

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT02349412
• Other Study ID Numbers: A221303; U10CA037447; UG1CA189823; NCI-2014-01943
• First Posted: Jan 28, 2015
• Last Update Posted: Jul 26, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Mesothelioma; Mesothelioma, Malignant; Bile Duct Neoplasms; Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Period Title: Overall Study
STARTED	202	203
Completed Week-12 QOL Assessment Measure	92	101
Completed Week-24 QOL Assessment Measure	68	80
COMPLETED	195	196
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)	Total
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.	Total of all reporting groups
Overall Participants	195	196	391
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	65.5	65.0	65.2
Sex: Female, Male (Count of Participants)
Female	81 41.5%	89 45.4%	170 43.5%
Male	114 58.5%	107 54.6%	221 56.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1%	2 1%	4 1%
Asian	9 4.6%	6 3.1%	15 3.8%
Native Hawaiian or Other Pacific Islander	0 0%	2 1%	2 0.5%
Black or African American	24 12.3%	22 11.2%	46 11.8%
White	148 75.9%	155 79.1%	303 77.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	12 6.2%	9 4.6%	21 5.4%
Region of Enrollment (Count of Participants)
United States	195 100%	196 100%	391 100%
ECOG Performance Status (Count of Participants)
0	47 24.1%	41 20.9%	88 22.5%
1	108 55.4%	127 64.8%	235 60.1%
2	40 20.5%	28 14.3%	68 17.4%

Outcome Measures

1. Primary Outcome

Title	Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Description	Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Measure Participants	92	101
Mean (Standard Deviation) [units on a scale]	3.35 (14.7)	0.12 (12.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.104
	Comments
	Method	ANCOVA
	Comments	Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.23
	Confidence Interval	(2-Sided) 95%; -0.67 to 7.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Description	Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL.
Time Frame	Up to 24 weeks

Outcome Measure Data

Analysis Population Description

Only participants with available data on the individual study measure at baseline and 24 weeks were included in the analysis.

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Measure Participants	68	80
Mean (Standard Deviation) [units on a scale]	3.80 (15.3)	0.69 (13.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.188
	Comments
	Method	ANCOVA
	Comments	Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.12
	Confidence Interval	(2-Sided) 95%; -1.54 to 7.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression
Description	Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Measure Participants	100	112
Mean (Standard Deviation) [units on a scale]	0.54 (4.0)	0.46 (3.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.884
	Comments
	Method	ANCOVA
	Comments	Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; -0.94 to 2.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety
Description	Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Measure Participants	100	111
Mean (Standard Deviation) [units on a scale]	-1.13 (2.7)	-0.32 (2.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	ANCOVA
	Comments	Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.81
	Confidence Interval	(2-Sided) 95%; -1.54 to -0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire
Description	Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: "Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying?" responses at Week-12 are reported below.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Only participants with available data on the individual study measure at week 12 were included in the analysis.

Arm/Group Title	Arm 1 (Early Palliative Care)	Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.	Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
Measure Participants	99	110
Yes	30 15.4%	16 8.2%
No	69 35.4%	94 48%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (Early Palliative Care), Arm 2 (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	Change in QOL on the SF-36 Over Time
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Rate of Referral, Enrollment and Length of Stay on Hospice
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Location of Death
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Number of Hospital and Intensive Care Unit (ICU) Admissions and Days
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Chemotherapy and Radiation Administration
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Overall Survival
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Concordance Between Patient and Family Caregiver Report of Prognosis/Curability
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events were not collected for this study.
Adverse Event Reporting Description	Adverse events were not collected for this study.
Arm/Group Title	Arm 1 (Early Palliative Care)		Arm 2 (Usual Care)
Arm/Group Description	Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years.		Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family.
All Cause Mortality
	Arm 1 (Early Palliative Care)		Arm 2 (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Arm 1 (Early Palliative Care)		Arm 2 (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm 1 (Early Palliative Care)		Arm 2 (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.