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

Lung Cancer Clinical Trial

Official title:

Piloting 'mPal,' a Multilevel Implementation Strategy to Integrate Non-hospice Palliative Care Into Advanced Stage Lung Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270395
• Other study ID #: 74152
• Secondary ID: 2KL2TR001996-05A
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Laurie McLouth, PhD
• Phone: 859-562-2526
• Email: laurie.mclouth[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• mPal
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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Laurie McLouth	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of enrollment: Proportion of eligible and approached patients who agree to participate	Proportion of eligible and approached patients who agree to participate	up to 6 months
Secondary	Patient palliative care referrals	Proportion of patients in each arm who receive a referral to palliative care within 1-month and 3-months post-intervention	up to 3-months post-intervention
Secondary	Acceptability of intervention	4-item acceptability of intervention measure (AIM); items responded to on a 5-point Likert-type scale with higher scores indicating greater acceptability.	up to 2 weeks post-intervention viewing
Secondary	Change in palliative care attitudes	Palliative Care Attitudes Scale; 9-items responded to on a Likert-type scale with higher scores indicating more favorable attitudes and motivation towards palliative care	Baseline, up to 2-months post intervention
Secondary	Feasibility of intervention	4-item feasibility of intervention measure (FIM); items responded to on a 5-point Likert-type scale with higher scores indicating higher feasibility.	up to 2 weeks post-intervention viewing
Secondary	Change in palliative care knowledge	Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire; 10-items responded to on a Likert-type scale. Items are examined individually	Baseline, up to 2-months post-intervention
Secondary	Feasibility of retention	Proportion of patients who complete baseline and follow-up questionnaire	up to 2-months post-intervention