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

NCT ID: NCT02349412

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-25
• Study Completion Date: 2019-07-15

Brief 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.

Detailed 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1

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.

Group Type: EXPERIMENTAL

Early palliative care

Intervention Type: OTHER

Arm 2

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.

Group Type: EXPERIMENTAL

Early palliative care

Intervention Type: OTHER

Interventions

Early palliative care

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Temel, MD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

UC San Diego Moores Cancer Center

La Jolla, California, United States

Queen's Medical Center

Honolulu, Hawaii, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

North Shore-LIJ Health System/Center for Advanced Medicine

New Hyde Park, New York, United States

Columbia University/Herbert Irving Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Altru Cancer Center

Grand Forks, North Dakota, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Temel JS, Sloan J, Zemla T, Greer JA, Jackson VA, El-Jawahri A, Kamdar M, Kamal A, Blinderman CD, Strand J, Zylla D, Daugherty C, Furqan M, Obel J, Razaq M, Roeland EJ, Loprinzi C. Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303. J Palliat Med. 2020 Jul;23(7):922-929. doi: 10.1089/jpm.2019.0377. Epub 2020 Feb 7.

Reference Type: DERIVED

PMID: 32031887 (View on PubMed)

Jacobs JM, Shaffer KM, Nipp RD, Fishbein JN, MacDonald J, El-Jawahri A, Pirl WF, Jackson VA, Park ER, Temel JS, Greer JA. Distress is Interdependent in Patients and Caregivers with Newly Diagnosed Incurable Cancers. Ann Behav Med. 2017 Aug;51(4):519-531. doi: 10.1007/s12160-017-9875-3.

Reference Type: DERIVED

PMID: 28097515 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Other Identifiers

U10CA037447

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2014-01943

Identifier Type: REGISTRY

Identifier Source: secondary_id

A221303

Identifier Type: -

Identifier Source: org_study_id