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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

Trial Status: Closed to Accrual and Intervention

This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients with lung or non-colorectal gastrointestinal cancer that cannot be cured and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life of family caregivers.

Inclusion Criteria

  • PATIENT: Confirmed incurable lung cancer (non-small cell lung cancer [NSCLC], small cell lung cancer, or mesothelioma) or non-colorectal gastrointestinal (GI) cancer (esophageal, gastric, hepatic, biliary, or pancreatic or GI unknown primary) not being treated with curative intent
  • PATIENT: Informed of diagnosis of incurable disease within the previous 8 weeks
  • PATIENT: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • PATIENT: Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member
  • PATIENT: Planning to receive all medical care for cancer at the enrolling institution
  • PATIENT: Participants must be under the care of an oncologist (who does not practice as a palliative care physician for that patient), but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies
  • CAREGIVER: Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits
  • CAREGIVER: Family caregiver must live with the patient or have in-person contact with him or her at least twice per week
  • CAREGIVER: Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member

California

La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Eric James Roeland
Phone: 858-822-5354

Hawaii

Honolulu
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey L. Berenberg
Phone: 808-524-6115

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Keller Daugherty
Phone: 773-834-7424
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nicholas Paul Campbell
Phone: 847-570-2109
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nicholas Paul Campbell
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nicholas Paul Campbell
Phone: 847-570-2109

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Laith Abushahin
Phone: 800-237-1225

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jennifer Gold Temel
Phone: 877-726-5130

Michigan

Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230

Minnesota

Minneapolis
Hennepin County Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Joseph W. Leach
Phone: 952-993-1517
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Kathryn J. Ruddy
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: CLOSED_TO_ACCRUAL
Contact: Joseph W. Leach
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Joseph W. Leach
Phone: 952-993-1517

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Amelia Morey Cullinan
Phone: 800-639-6918

New York

Lake Success
Northwell Health / Center for Advanced Medicine
Status: CLOSED_TO_ACCRUAL
Contact: James T. D'Olimpio
Phone: 516-734-8954
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul Eliezer Oberstein
Phone: 212-305-8615

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Crawford
Phone: 888-275-3853

North Dakota

Grand Forks
Altru Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Grant Richard Seeger
Phone: 701-780-6520

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Mohammad Abdul Razaq
Phone: 405-271-8777

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Egidio Del Fabbro
Phone: 804-628-1939

Wisconsin

La Crosse
Gundersen Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael O Ojelabi
Phone: 608-775-2385
Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Michael T. Claessens
Phone: 715-389-4457
Milwaukee
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Wendy Larson Peltier
Phone: 414-805-4380

PRIMARY OBJECTIVES:

I. To determine the efficacy of early integrated palliative care (PC) on patient reported quality-of-life (QOL) at 12 weeks using the Functional Assessment of Cancer Therapy (FACT) in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer.

SECONDARY OBJECTIVES:

I. To determine the efficacy of early integrated palliative care (PC) on other patient reported outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints detailed.

II. To determine the efficacy of early integrated palliative care (PC) on family caregiver reported outcomes in those with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints detailed.

III. To assess the impact of early, integrated PC on quality of end-of-life (EOL) care and resource utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by assessing the endpoints detailed.

IV. To determine concordance between patient and family caregiver report of prognosis/curability.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (EARLY PALLIATIVE CARE): Patients receive standard oncology care and early integrated palliative care comprising clinic visits (or phone calls if visits are not feasible) at baseline and as needed or at least every 4 weeks throughout the patient’s life.

ARM II (STANDARD ONCOLOGY CARE): Patients receive standard oncology care.

After completion of study, patients are followed up every 4 months from week 24 to up to 3 years.

Trial Phase Phase III

Trial Type Supportive care

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Jennifer Gold Temel

  • Primary ID A221303
  • Secondary IDs NCI-2014-01943
  • Clinicaltrials.gov ID NCT02349412