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Completed

NCT Number: NCT05270395

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Enrollment

    Time frame: up to 6 months

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

Secondary outcomes

  1. Patient Palliative Care Referrals

    Time frame: 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

  2. Acceptability of Intervention

    Time frame: 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.

  3. Change in Palliative Care Attitudes

    Time frame: 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.

  4. Feasibility of Intervention

    Time frame: 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.

  5. Feasibility of Retention

    Time frame: up to 2-months post-intervention

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

  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?

    Time frame: 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 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").

  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

    Time frame: 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 "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.

  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

    Time frame: 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 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.

  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

    Time frame: 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 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.

  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

    Time frame: 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 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.

  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

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

  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

    Time frame: Baseline and at 1-month follow-up

    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.

  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

    Time frame: Baseline and at 1-month follow-up

    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.

  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

    Time frame: Baseline and at 1-month follow-up

    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.

  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

    Time frame: Baseline and at 1-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Laurie McLouth

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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