Ignite Creation Date:
2024-05-06 @ 3:40 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02349412
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2015-01-23
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
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 esophagealgastric vs hepaticbiliarypancreatic 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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-01943 | REGISTRY | NCI Clinical Trial Reporting Program Office | httpsreporternihgovquickSearchUG1CA189823 |
| U10CA037447 | NIH | None | None |
| UG1CA189823 | NIH | None | None |