Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation
Purpose
The purpose of this study is to assess the feasibility and acceptability of mPal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment.
Condition
- Lung Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- new or recurrent AJCC stage IIIb-IV non-small cell lung cancer or extensive stage small cell lung cancer - ECOG performance status 0-3/Karnofsky 40-100 - at least three weeks into active oncologic treatment (chemotherapy, immunotherapy, chemo-immunotherapy)
Exclusion Criteria
- unstable brain metastases - Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate - Receiving palliative care - Unable to speak and read English
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental mPal intervention |
Participants in this group will receive the mPal intervention. mPal's patient content includes a multi-component web-based tool with the following: (1) a brief educational video that seeks to educate patients about palliative care; (2) and assessment of palliative care knowledge; (3) assessment of palliative care needs; and (4) an assessment of whether patients would like to meet with palliative care or discuss palliative care and their palliative care needs with their oncology provider. mPal's provider content (not randomized) will include education. System-level modifications will also be made to the electronic health record to facilitate palliative care discussions and referrals. |
|
|
No Intervention Standard of care |
Participants in this group will receive standard of care (applies to patients only). |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40506
More Details
- NCT ID
- NCT05270395
- Status
- Recruiting
- Sponsor
- Laurie McLouth
Detailed Description
In this study, 60 advanced stage lung cancer patients will be randomized to mPal's patient-level component or usual care. Oncology providers will receive the mPal intervention. mPal is designed to help oncology providers integrate outpatient palliative care (non-hospice palliative care; NHPC) into routine clinical practice through: 1) electronic health record enhancements; 2) patient education and preparation for NHPC discussions when patients are in clinic to see their oncology providers; and 3) provider education about NHPC. This study will examine the feasibility and acceptability of mPal and gather preliminary data on potential outcomes for a future effectiveness trial.