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

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 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.