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
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 |
---|---|---|
|
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
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
- 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
- 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.
- 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.
- 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.
- 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.
- Change in QOL on the SF-36 Over Time [Up to 3 years]
- Rate of Referral, Enrollment and Length of Stay on Hospice [Up to 3 years]
- Location of Death [Up to 3 years]
- Number of Hospital and Intensive Care Unit (ICU) Admissions and Days [Up to 3 years]
- Chemotherapy and Radiation Administration [Up to 3 years]
- Overall Survival [Up to 3 years]
- Concordance Between Patient and Family Caregiver Report of Prognosis/Curability [Up to 3 years]
Eligibility Criteria
Criteria
Study Patient Participant Eligibility Requirements:
-
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.
-
Informed of diagnosis of incurable disease within the previous 8 weeks.
-
Age ≥ 18 years
-
ECOG Performance Status 0-2
-
Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.
-
Planning to receive all medical care for cancer at the enrolling institution.
-
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:
-
Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits.
-
Family caregiver must live with the patient or have in-person contact with him or her at least twice per week.
-
Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.
-
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)
More Information
Additional Information:
Publications
None provided.- A221303
- U10CA037447
- UG1CA189823
- NCI-2014-01943
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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
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 |
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 |
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 |
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 |
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 |
Title | Change in QOL on the SF-36 Over Time |
---|---|
Description | |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Rate of Referral, Enrollment and Length of Stay on Hospice |
---|---|
Description | |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Location of Death |
---|---|
Description | |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Number of Hospital and Intensive Care Unit (ICU) Admissions and Days |
---|---|
Description | |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Chemotherapy and Radiation Administration |
---|---|
Description | |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Overall Survival |
---|---|
Description | |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Concordance Between Patient and Family Caregiver Report of Prognosis/Curability |
---|---|
Description | |
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
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.
Results Point of Contact
Name/Title | Jennifer Temel, MD |
---|---|
Organization | Massachusetts General Hospital Cancer Center |
Phone | (617) 724-0453 |
jtemel@partners.org |
- A221303
- U10CA037447
- UG1CA189823
- NCI-2014-01943