Clinical trial NCT05270395: Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation
Official title: Piloting 'mPal,' a Multilevel Implementation Strategy to Integrate Non-hospice Palliative Care Into Advanced Stage Lung Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Palliative care
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-03-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Enrollment
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient Palliative Care Referrals
timeFrame: up to 3-months post-intervention
measure: Acceptability of Intervention
timeFrame: up to 2 weeks post-intervention viewing
measure: Change in Palliative Care Attitudes
timeFrame: Baseline, up to 2-months post intervention
measure: Feasibility of Intervention
timeFrame: up to 2 weeks post-intervention viewing
measure: Feasibility of Retention
timeFrame: up to 2-months post-intervention
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 1: How Would You Describe Your Level of Knowledge About Palliative Care?
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 2: Help Friends and Family to Cope With a Patient's Illness
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 4: Manage Pain and Other Physical Symptoms
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 5: Give Patients More Time at the End of Life
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 6: Accepting Palliative Care Means Giving up
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 7: It is a Doctor's Obligation to Inform All Patients With Cancer About the Option of Palliative Care
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 8: If You Accept Palliative Care, You Must Stop Other Treatments
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 9: Palliative Care is the Same as Hospice Care
timeFrame: Baseline and at 1-month follow-up
measure: Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 10: When I Think of "Palliative Care," I Automatically Think of Death
timeFrame: Baseline and at 1-month follow-up
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Laurie McLouth, PhD
role: PRINCIPAL_INVESTIGATOR
References: