CompletedPhase 3NCT02349412
Official study title

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 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedEarly palliative care

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 7, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Other: Early palliative care
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UC San Diego Moores Cancer CenterLa Jolla, California
  • Queen's Medical CenterHonolulu, Hawaii
  • University of Chicago Comprehensive Cancer CenterChicago, Illinois
  • NorthShore University HealthSystem-Evanston HospitalEvanston, Illinois
  • NorthShore University HealthSystem-Glenbrook HospitalGlenview, Illinois
  • NorthShore University HealthSystem-Highland Park HospitalHighland Park, Illinois
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, Iowa
  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts
  • Mercy Health Saint Mary'sGrand Rapids, Michigan
  • Hennepin County Medical CenterMinneapolis, Minnesota
  • Mayo ClinicRochester, Minnesota
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2025. Always confirm current availability with the study team.

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