NCT05270395

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

Completed NA Results posted Last updated 13 May 2025

What this trial tests

NA trial testing mPal in Lung Cancer in 75 participants. Completed in 1 June 2024.

Timeline

28 July 2022

Primary endpoint
22 March 2024

1 June 2024

Quick facts

Lead sponsor	Laurie McLouth
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	75
Start date	28 July 2022
Primary completion	22 March 2024
Estimated completion	1 June 2024
Sites	1 location across United States

Drugs / interventions tested

• mPal

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Laurie McLouth

Who can join

Adults 18 to 100, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Enrollment Primary · up to 6 months

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

Group	Value	95% CI
Eligible Participants	75

Patient Palliative Care Referrals Secondary · up to 3-months post-intervention

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

Group	Value	95% CI
mPal Intervention	2
Standard of Care	2

Acceptability of Intervention Secondary · up to 2 weeks post-intervention viewing

4-item acceptability of intervention measure (AIM); items responded to on a 5-point Likert-type scale (1 - 5) with higher scores indicating greater acceptability.

Group	Value	95% CI
mPal Intervention	3.95	± 0.64

Change in Palliative Care Attitudes Secondary · Baseline, up to 2-months post intervention

Palliative Care Attitudes Scale; 9-items responded to on a Likert-type scale (range 9 - 60) with higher scores indicating more favorable attitudes and motivation towards palliative care. Mean change in total score at Time 2 is presented, adjusted for the baseline value of PCAS Total Score at baseline, age, and sex.

Group	Value	95% CI
mPal Intervention	1.12	± 1.33
Standard of Care	-0.07	± 1.37

Feasibility of Intervention Secondary · up to 2 weeks post-intervention viewing

4-item feasibility of intervention measure (FIM); items responded to on a 5-point Likert-type scale (1 - 5) with higher scores indicating higher feasibility.

Group	Value	95% CI
mPal Intervention	4.03	± 0.56

Feasibility of Retention Secondary · up to 2-months post-intervention

Feasibility of retention is defined as the number of patients who complete baseline and follow-up questionnaire

Group	Value	95% CI
mPal Intervention	30
Standard of Care	30

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? Secondary · Baseline and at 1-month follow-up

The percentage of participants responding, "know what palliative care is and could explain it to someone else" reported. Odds ratio was calculated using logistic regression. Item 1 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to respond to this question: "How would you describe your level of knowledge about palliative care?" Participants can respond, "I've never heard of it," "I know a little bit about palliative care," or "I know what palliative care is and could explain it to someone else." For the analys

Group	Value	95% CI
mPal Intervention	35.71
Standard of Care	14.29

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 Secondary · Baseline and at 1-month follow-up

The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 2 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Help friends and family to cope with a patient's illness." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "

Group	Value	95% CI
mPal Intervention	76.67
Standard of Care	70.37

Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support Secondary · Baseline and at 1-month follow-up

The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 3 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Offer social and emotional support." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree" ("Strongly agre

Group	Value	95% CI
mPal Intervention	73.33
Standard of Care	88.46

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 Secondary · Baseline and at 1-month follow-up

The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 4 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Manage pain and other physical symptoms." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree" ("Strongly

Group	Value	95% CI
mPal Intervention	76.67
Standard of Care	84.62

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 Secondary · Baseline and at 1-month follow-up

The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 5 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Give patients more time at the end of life." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't

Group	Value	95% CI
mPal Intervention	26.67
Standard of Care	15.38

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 Secondary · Baseline and at 1-month follow-up

The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 6 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement about palliative care: "Accepting palliative care means giving up." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't know" ("Strongly

Group	Value	95% CI
mPal Intervention	80.00
Standard of Care	62.96

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Piloting a Patient Tool to Aid Palliative Care Referrals during Advanced Lung Cancer Treatment.
   McLouth LE, Stapleton JL, Bursac V, Zelaya CM, et al · · 2024 · cited 1× · PMID 38219963 · DOI 10.1016/j.jpainsymman.2024.01.013