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
Condition: 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
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Mesothelioma; Mesothelioma, Malignant; Bile Duct Neoplasms; Anxiety Disorders
Intervention: Early palliative care
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.