Lung Cancer
Conditions
Keywords
Palliative care
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.
Interventions
BEHAVIORALmPal
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Laurie McLouth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment | up to 6 months | Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | 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. |
| Change in Palliative Care Attitudes | 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. |
| Feasibility of Intervention | 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. |
| Feasibility of Retention | up to 2-months post-intervention | Feasibility of retention is defined as the number of patients who complete baseline and follow-up questionnaire |
| 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? | 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). |
| 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 | 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. |
| Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support | 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. |
| Patient Palliative Care Referrals | 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 |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
In this study, individuals were not randomized until they completed the baseline assessment. Although 75 participants were consented, only 68 completed baseline assessments and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| mPal Intervention 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.
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. | 34 |
| Standard of Care Participants in this group will receive standard of care (applies to patients only). | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Study Team Withdrew | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | Total | mPal Intervention |
|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 11.5 | 62.0 years STANDARD_DEVIATION 9.9 | 62.9 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 64 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 57 Participants | 29 Participants |
| Region of Enrollment United States | 34 participants | 68 participants | 34 participants |
| Sex: Female, Male Female | 20 Participants | 41 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 34 | 2 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Feasibility of Enrollment
Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate
Time frame: up to 6 months
Population: Participants were not randomized until they completed baseline assessment, thus, this number is the total individuals eligible.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Feasibility of Enrollment | 75 Participants |
Secondary
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.
Time frame: up to 2 weeks post-intervention viewing
Population: The intervention was only administered to the mPal arm. Participants that completed enough items to calculate a score were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Participants | Acceptability of Intervention | 3.95 score on a scale | Standard Deviation 0.64 |
Secondary
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.
Time frame: Baseline, up to 2-months post intervention
Population: Participants that completed enough items at the Time 2 assessment were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Participants | Change in Palliative Care Attitudes | 1.12 score on a scale | Standard Error 1.33 |
| Standard of Care | Change in Palliative Care Attitudes | -0.07 score on a scale | Standard Error 1.37 |
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 70.00 Percentage of participants |
| Standard of Care | 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 | 34.62 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.00495% CI: [1.99, 34.49]Regression, Logistic
Secondary
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).
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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? | 35.71 Percentage of participants |
| Standard of Care | 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? | 14.29 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.0295% CI: [1.38, 46.69]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 76.67 Percentage of participants |
| Standard of Care | 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 | 70.37 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.6395% CI: [0.4, 4.56]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support | 73.33 Percentage of participants |
| Standard of Care | Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support | 88.46 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.1395% CI: [0.06, 1.46]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 76.67 Percentage of participants |
| Standard of Care | 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 | 84.62 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.495% CI: [0.13, 2.24]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 26.67 Percentage of participants |
| Standard of Care | 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 | 15.38 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.2995% CI: [0.51, 9.62]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 80.00 Percentage of participants |
| Standard of Care | 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 | 62.96 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.0795% CI: [0.88, 14.32]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 72.41 Percentage of participants |
| Standard of Care | 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 | 67.86 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.0995% CI: [0.82, 18.89]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 73.33 Percentage of participants |
| Standard of Care | 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 | 62.96 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.4295% CI: [0.46, 6.43]Regression, Logistic
Secondary
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.
Time frame: Baseline and at 1-month follow-up
Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | 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 | 66.67 Percentage of participants |
| Standard of Care | 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 | 48.15 Percentage of participants |
Comparison: We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.p-value: 0.0895% CI: [0.87, 9.42]Regression, Logistic
Secondary
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.
Time frame: up to 2 weeks post-intervention viewing
Population: Administered only to intervention participants; Participants that completed enough items at the Time 2 assessment were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Participants | Feasibility of Intervention | 4.03 score on a scale | Standard Deviation 0.56 |
Secondary
Feasibility of Retention
Feasibility of retention is defined as the number of patients who complete baseline and follow-up questionnaire
Time frame: up to 2-months post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Feasibility of Retention | 30 Participants |
| Standard of Care | Feasibility of Retention | 30 Participants |
Secondary
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
Time frame: up to 3-months post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Patient Palliative Care Referrals | 2 Participants |
| Standard of Care | Patient Palliative Care Referrals | 2 Participants |