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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349412
Other study ID # A221303
Secondary ID U10CA037447UG1CA
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2015
Est. completion date July 15, 2019

Study information

Verified date July 2021
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 405
Est. completion date July 15, 2019
Est. primary completion date July 3, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Early palliative care


Locations

Country Name City State
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Altru Cancer Center Grand Forks North Dakota
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Queen's Medical Center Honolulu Hawaii
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Marshfield Clinic Marshfield Wisconsin
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States Hennepin County Medical Center Minneapolis Minnesota
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 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
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

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL. Up to 12 weeks
Secondary Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL. Up to 24 weeks
Secondary Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms. Up to 12 weeks
Secondary Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms. Up to 12 weeks
Secondary Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: "Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying?" responses at Week-12 are reported below. Up to 12 weeks
Secondary Change in QOL on the SF-36 Over Time Up to 3 years
Secondary Rate of Referral, Enrollment and Length of Stay on Hospice Up to 3 years
Secondary Location of Death Up to 3 years
Secondary Number of Hospital and Intensive Care Unit (ICU) Admissions and Days Up to 3 years
Secondary Chemotherapy and Radiation Administration Up to 3 years
Secondary Overall Survival Up to 3 years
Secondary Concordance Between Patient and Family Caregiver Report of Prognosis/Curability Up to 3 years
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