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

Last updated: January 15, 2025
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Small Cell Lung Cancer

Mesothelioma

Pancreatic Cancer

Treatment

Early palliative care

Clinical Study ID

NCT02349412
A221303
NCI-2014-01943
UG1CA189823
U10CA037447
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 405
Treatment Group(s): 1
Primary Treatment: Early palliative care
Phase: 3
Study Start date:
June 25, 2015
Estimated Completion Date:
July 15, 2019

Study 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

Connect with a study center

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois 60026
    United States

    Site Not Available

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • North Shore-LIJ Health System/Center for Advanced Medicine

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Columbia University/Herbert Irving Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Altru Cancer Center

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • Marshfield Clinic

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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