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

Phase 3

Completed

Conditions: Small Cell Lung Cancer
Extrahepatic Bile Duct Cancer
Malignant Mesothelioma
Non-small Cell Lung Cancer
Depression
Anxiety Disorder
Gastric Cancer
Liver Cancer
Pancreatic Cancer
Esophageal Cancer

Registration Number: NCT02349412

Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 405

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in QOL on the SF-36 Over Time	Up to 3 years
Location of Death	Up to 3 years
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 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.
Concordance Between Patient and Family Caregiver Report of Prognosis/Curability	Up to 3 years
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.
Rate of Referral, Enrollment and Length of Stay on Hospice	Up to 3 years
Chemotherapy and Radiation Administration	Up to 3 years
Overall Survival	Up to 3 years
Number of Hospital and Intensive Care Unit (ICU) Admissions and Days	Up to 3 years

Trial Locations

Locations (23): UC San Diego Moores Cancer Center
🇺🇸
La Jolla, California, United States
Queen's Medical Center
🇺🇸
Honolulu, Hawaii, United States
University of Chicago Comprehensive Cancer Center
🇺🇸
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
🇺🇸
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
🇺🇸
Highland Park, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸
Iowa City, Iowa, United States
Massachusetts General Hospital Cancer Center
🇺🇸
Boston, Massachusetts, United States
Mercy Health Saint Mary's
🇺🇸
Grand Rapids, Michigan, United States
Hennepin County Medical Center
🇺🇸
Minneapolis, Minnesota, United States
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UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States