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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

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

Treatments: Other: Early palliative care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02349412

UG1CA189823 (U.S. NIH Grant/Contract)

A221303

U10CA037447 (U.S. NIH Grant/Contract)

NCI-2014-01943 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 405 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

Arm 1

Experimental 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.

Treatment:

Other: Early palliative care

Arm 2

Experimental group

Description:

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.

Treatment:

Other: Early palliative care