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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

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.

Tracking Information
First Received DateJanuary 23, 2015
Last Changed DateApril 19, 2017
Start DateApril 2015
Anticipated Primary Completion DateJune 2018
Primary Outcome Measures

Change in FACT-G scores from baseline to 12 weeks between study arms [Time Frame: Up to 12 weeks]

Secondary Outcome Measures

Change in QOL on the FACT over time [Time Frame: Up to 24 weeks]

Rate of depressive symptoms as per Hospital Anxiety and Depression Scale (HADS) at 12 weeks and over time [Time Frame: Up to 3 years]

Rate of anxiety symptoms as per HADS at 12 weeks and over time [Time Frame: Up to 3 years]

Change in illness understanding over time [Time Frame: Up to 3 years]

Change in QOL on the SF-36 over time [Time Frame: Up to 3 years]

Rate of referral, enrollment and length of stay on hospice [Time Frame: Up to 3 years]

Location of death [Time Frame: Up to 3 years]

Number of hospital and intensive care unit (ICU) admissions and days [Time Frame: Up to 3 years]

Chemotherapy and radiation administration [Time Frame: Up to 3 years]

Overall survival [Time Frame: Up to 3 years]

Concordance between patient and family caregiver report of prognosis/curability [Time Frame: Up to 3 years]

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • 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
Intervention
  • Other: Early palliative care
Study Arms / Comparison Groups2 / 0
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

Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment405
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Eligibility 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.

Administrative Information
NCTIDNCT02349412
Responsible Party,
SponsorAlliance for Clinical Trials in Oncology
Verification DateApril 2017
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

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