Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation

Laurie McLouth

Status: Completed

Conditions: Lung Cancer

Treatments: Behavioral: mPal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05270395

74152

2KL2TR001996-05A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

mPal intervention

Experimental group

Description:

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.

Treatment:

Behavioral: mPal

Standard of care

No Intervention group

Description:

Participants in this group will receive standard of care (applies to patients only).