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Lung CancerNCT05270395

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

A study testing mPal in people with Lung Cancer, run by Laurie McLouth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Lung Cancer
What is being tested?
mPal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
28 Jul 2022to 1 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40506

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
mPal
Keywords
Palliative care
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mPalBehavioural

    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.

Study groups in NCT05270395
Study groupRoleWhat they receive
mPal interventionExperimentalParticipants 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.
Receives: Behavioral: mPal
Standard of careNo interventionParticipants in this group will receive standard of care (applies to patients only).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Enrollment

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

    Measured: up to 6 months

Secondary outcomes (15)
  1. Patient Palliative Care Referrals

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

    Measured: up to 3-months post-intervention

  2. Acceptability of Intervention

    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.

    Measured: up to 2 weeks post-intervention viewing

  3. Change in Palliative Care Attitudes

    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.

    Measured: Baseline, up to 2-months post intervention

  4. Feasibility of Intervention

    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.

    Measured: up to 2 weeks post-intervention viewing

  5. Feasibility of Retention

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

    Measured: up to 2-months post-intervention

  6. 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?

    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 analysis, the first two responses were collapsed to create a dichotomous variable ("have no or little knowledge of palliative care" versus "know what palliative care is and could explain it to someone else").

    Measured: Baseline and at 1-month follow-up

  7. 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

    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 "Agree" ("Strongly agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified correct knowledge of palliative care.

    Measured: Baseline and at 1-month follow-up

  8. Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support

    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 agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified correct knowledge of palliative care.

    Measured: Baseline and at 1-month follow-up

  9. 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

    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 agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified correct knowledge of palliative care.

    Measured: Baseline and at 1-month follow-up

  10. 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

    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 know" ("Strongly agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified correct knowledge of palliative care.

    Measured: Baseline and at 1-month follow-up

  11. 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

    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 agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified positive belief about palliative care.

    Measured: Baseline and at 1-month follow-up

  12. Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 7: It is a Doctor's Obligation to Inform All Patients With Cancer About the Option of Palliative Care

    The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression.

    Item 7 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: "It is a doctor's obligation to inform all patients with cancer about the option of palliative care." 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 agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified positive belief about palliative care.

    Measured: Baseline and at 1-month follow-up

  13. Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 8: If You Accept Palliative Care, You Must Stop Other Treatments

    The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression.

    Item 8 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: "If you accept palliative care, you must stop other treatments." 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 agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified correct knowledge of palliative care.

    Measured: Baseline and at 1-month follow-up

  14. Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 9: Palliative Care is the Same as Hospice Care

    The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression.

    Item 9 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: "Palliative care is the same as hospice care." 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 agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified correct knowledge of palliative care.

    Measured: Baseline and at 1-month follow-up

  15. Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 10: When I Think of "Palliative Care," I Automatically Think of Death

    The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression.

    Item 10 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: "When I think of "palliative care," I automatically think of death." 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 agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified positive belief about palliative care.

    Measured: Baseline and at 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start28 Jul 2022
  3. Primary completion22 Mar 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05270395
Sponsor's protocol ID
74152
Other IDs
2KL2TR001996-05A1
Status last verified
Apr 2025
First submitted
1 Feb 2022
Last updated
13 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing mPal in people with Lung Cancer, run by Laurie McLouth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Enrollment (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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