Brief Title
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
Official Title
Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Incurable Lung or Non-Colorectal Gastrointestinal Malignancies
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Secondary Outcome
Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Condition
Liver Cancer
Intervention
Early palliative care
Study Arms / Comparison Groups
Arm 1
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
405
Start Date
April 2015
Completion Date
July 15, 2019
Primary Completion Date
July 3, 2017
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jennifer Temel, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02349412
Organization ID
A221303
Secondary IDs
U10CA037447
Responsible Party
Sponsor
Study Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Jennifer Temel, MD, Study Chair, Massachusetts General Hospital
Verification Date
October 2019