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

Primary Purpose

Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mPal

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Palliative care

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mPal intervention

Standard of care

Arm 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.

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

Outcomes

Primary Outcome Measures

Feasibility of enrollment: Proportion of eligible and approached patients who agree to participate

Proportion of eligible and approached patients who agree to participate

Secondary Outcome Measures

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

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.

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

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.

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

Feasibility of retention

Proportion of patients who complete baseline and follow-up questionnaire

Full Information

NCT ID

NCT05270395

First Posted

February 1, 2022

Last Updated

August 2, 2023

Sponsor

Laurie McLouth

Collaborators

National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT05270395

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Laurie McLouth

Collaborators

National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Palliative care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mPal intervention

Arm Type

Experimental

Arm Description

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

mPal

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of enrollment: Proportion of eligible and approached patients who agree to participate

Description

Proportion of eligible and approached patients who agree to participate

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Patient palliative care referrals

Description

Proportion of patients in each arm who receive a referral to palliative care within 1-month and 3-months post-intervention

Time Frame

up to 3-months post-intervention

Title

Acceptability of intervention

Description

4-item acceptability of intervention measure (AIM); items responded to on a 5-point Likert-type scale with higher scores indicating greater acceptability.

Time Frame

up to 2 weeks post-intervention viewing

Title

Change in palliative care attitudes

Description

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

Time Frame

Baseline, up to 2-months post intervention

Title

Feasibility of intervention

Description

4-item feasibility of intervention measure (FIM); items responded to on a 5-point Likert-type scale with higher scores indicating higher feasibility.

Time Frame

up to 2 weeks post-intervention viewing

Title

Change in palliative care knowledge

Description

Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire; 10-items responded to on a Likert-type scale. Items are examined individually

Time Frame

Baseline, up to 2-months post-intervention

Title

Feasibility of retention

Description

Proportion of patients who complete baseline and follow-up questionnaire

Time Frame

up to 2-months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laurie McLouth, PhD

Phone

859-562-2526

laurie.mclouth@uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurie McLouth, PhD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40506

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurie McLouth, PhD

Phone

859-562-2526

laurie.mclouth@uky.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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