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

NCT05270395 | Completed Results

• 2 other identifiers: 741522KL2TR001996-05A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Palliative care

Outcome Measures

Primary Outcomes (1)

• Feasibility of Enrollment

  Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate

  up to 6 months

Secondary Outcomes (15)

• Patient Palliative Care Referrals

  up to 3-months post-intervention

• Acceptability of Intervention

  up to 2 weeks post-intervention viewing

• Change in Palliative Care Attitudes

  Baseline, up to 2-months post intervention

• Feasibility of Intervention

  up to 2 weeks post-intervention viewing

• Feasibility of Retention

  up to 2-months post-intervention

Study Arms (2)

mPal intervention

EXPERIMENTAL

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.

Behavioral: mPal

Standard of care

NO INTERVENTION

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

Interventions

mPal BEHAVIORAL

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. The provider-level component includes provider education on palliative care. The system-level component includes electronic health record modifications to facilitate palliative care discussions and referrals.

mPal intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laurie McLouth: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. McLouth
• Organization: University of Kentucky

laurie.mclouth@uky.edu

859-562-2526

Study Officials

• Laurie McLouth, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 8, 2022
• Study Start: July 28, 2022
• Primary Completion: March 22, 2024
• Study Completion: June 1, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)