Lung Cancer
Conditions
Keywords
Lung Cancer palliative care
Brief summary
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
Detailed description
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about the cancer diagnosis. Research has shown that early involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms and in helping patients and their families cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called palliative care, and consists of physicians and advanced practice nurses (or nurse practitioners) who work closely and collaboratively with the oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they have better symptom control, quality of life, and mood, and their loved ones feel less distressed. the investigators call this model of care, early integrated palliative care. While the investigators know that having palliative care clinicians work closely with the oncology team is helpful for patients and their loved ones, many patients do not have access to these specialists because hospitals and cancer clinics lack enough staff and because some patients and family members live in distant regions that make attending clinic visits difficult and expensive. One way to overcome these barriers is to have patients meet with palliative care clinicians using secure video-conferencing technology. The purpose of this study is to determine if meeting with a palliative care clinician through video-conferencing is just as beneficial for patients and their families as meeting with a palliative care clinician in person. Specifically, this study will compare these two different strategies for meeting with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month in person at the clinic. The investigators call this strategy In-person palliative care. The second strategy is to schedule the participant to meet with the palliative care clinician regularly each month using secure video-conferencing, such as through a smart phone or tablet computer. If the participant do not have this form of technology, the investigators will provide it for the participant. The investigators call this strategy telehealth palliative care. The primary goals of this study are to learn if telehealth palliative care is just as effective as in-person palliative care for improving quality of life, mood symptoms, and satisfaction with care for patients with advanced lung cancer and their families.
Interventions
OTHERTelehealth Palliative Care
Teleconference meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness.
OTHERIn-person Palliative Care
In-person meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness.
Sponsors
Patient-Centered Outcomes Research Institute
Palliative Care Research Cooperative Group
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient Eligibility Criteria * Diagnosed with advanced non-small cell lung cancer being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 3 (symptomatic and in bed \>50% of the day) * The ability to read and respond to questions in English or Spanish * Receiving primary cancer care at one of the participating sites * Age \> or = 18 years * Lives in a state where their institutions' palliative care clinicians are licensed to practice * Caregiver Eligibility Criteria * Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week * The ability to read and respond to questions in English or Spanish * Age \> or = 18 years
Exclusion criteria
* Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Quality of Life | 24 Weeks | Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians | 48 weeks (or last assessment prior to death if before 48 weeks) | Compare the difference between study groups in the proportion of patients who reported that they discussed their end-of-life care preferences with their clinicians based on a single item from the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ includes a self-report item that assesses whether the patient communicated with their clinicians about their wishes for care if they were dying (i.e., scored dichotomously as yes vs. no). |
| Length of Stay in Hospice | From hospice enrollment until patient death during study period | Compare the difference between study groups in the length of stay in hospice (as measured in days) among patients who died during study period per medical record review. |
| Proportion of Patient's Palliative Care Visits With a Caregiver Present | 24 weeks | Compare the difference between study groups in the proportion of palliative care visits that had a caregiver present as documented by the palliative care clinician using a study visit summary form. |
| Patient-reported Satisfaction With Care | 24 weeks | Compare the difference between study groups in patient-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire, which has a total scale score range from 0-52 with higher scores indicating greater satisfaction. |
| Caregiver-reported Satisfaction With Care | 24 weeks | Compare the difference between study groups in caregiver-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire (caregiver version), which has a total scale score range from 0-48 with higher scores indicating greater satisfaction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Depression | up to 48 weeks | Compare the difference between study groups in patient-reported depression as measured by the Patient Health Questionnaire-9, which has a total scale score range from 0-27 with higher scores indicating more significant depression symptoms. |
| Health Care Utilization | Through study completion, average of 18 month follow up | Compare the difference between study groups in health care utilization as per medical record review of emergency department visits, hospital admissions, chemotherapy administration at the end of life, and hospice service use. |
| Patient-reported Coping Strategies | up to 48 weeks | Compare the difference between study groups in patient-reported coping strategies as measured by the Brief Cope (approach-oriented coping score range: 6-24, with higher scores indicating greater use of approach-oriented coping strategies; avoidant coping score range: 4-16, with higher scores indicating greater use of avoidant coping strategies). |
| Patient-reported Quality of Life | up to 48 weeks | Compare the difference between study groups in patient-reported quality of life across all study assessment time points as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better quality of life. |
| Caregiver-reported Quality of Patient Death | Up to 6 months after patient death during study period | Compare the difference between study groups in caregiver-reported quality of patient death as measured by the After Death Assessment, which includes three items that ask the caregiver to rate the quality of the patient's death (from 1 worst possible to 10 best possible), the degree of physical distress the patient experienced in their last week of life (from 1 none to 10 extremely distressed), and the degree of psychological distress the patient experienced in their last week of life (from 1 none to 10 extremely upset). |
| Patient-reported Prognostic Understanding | up to 48 weeks | Compare the difference between study groups in patient-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which patients rate two items about the goal of their cancer care (i.e., scored dichotomously as either to cure my cancer vs any other option) and whether their cancer is curable (i.e., scored dichotomously as yes or no). |
| Caregiver-reported Prognostic Understanding | up to 48 weeks | Compare the difference between study groups in caregiver-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which caregivers rate two items about the goal of their loved one's cancer care (i.e., scored dichotomously as either to cure his/her cancer vs any other option) and whether their loved one's cancer is curable (i.e., scored dichotomously as yes or no). |
| Caregiver-reported Quality of Life | up to 48 weeks | Compare the difference between study groups in caregiver-reported quality of life as measured by the Caregiver Oncology Quality of Life Questionnaire, which has a total scale score range of 0-100 with higher scores indicating better quality of life. |
| Caregiver-reported Mood Symptoms | up to 48 weeks | Compare the difference between study groups in caregiver-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms). |
| Patient-reported Mood Symptoms | up to 48 weeks | Compare the difference between study groups in patient-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms). |
Countries
United States
Participant flow
Recruitment details
Note: Caregiver enrollment in the study and attendance at palliative care visits were voluntary, and patients could participate without an enrolled caregiver. Only one caregiver per patient participant was invited to enroll in the study.
Participants by arm
| Arm | Count |
|---|---|
| Telehealth Palliative Care: Patient * Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment.
* Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks.
* Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician.
(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.)
Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness. | 633 |
| In-person Palliative Care: Patient * Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic.
* In-person palliative care visits will be scheduled on the same day as an oncology visit if possible.
(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.)
In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness. | 617 |
| Telehealth Palliative Care: Caregiver * Patient and caregiver will meet with the palliative care clinician in person within four weeks of enrollment.
* Subsequent visits with the palliative care clinician will be conducted with the patient and caregiver in their home or other location using video at least every four weeks.
* Patient and caregiver may be scheduled to meet with the palliative care clinician in the clinic if requested by the patient or a clinician.
(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.)
Telehealth Palliative Care: Teleconference meeting via video with the palliative care team. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness. | 272 |
| In-person Palliative Care: Caregiver * Patient and caregiver will be scheduled for their first in-person palliative care visit within four weeks of enrollment and then at least every four weeks thereafter until the patient is no longer coming into the clinic.
* In-person palliative care visits will be scheduled on the same day as an oncology visit if possible.
(Note: Caregiver enrollment in the study and attendance at palliative care visits are voluntary, and the patient can participate without an enrolled caregiver.)
In-person Palliative Care: In-person meeting with the palliative care team in clinic. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness. | 276 |
| Total | 1,798 |
Baseline characteristics
| Characteristic | Telehealth Palliative Care: Patient | In-person Palliative Care: Patient | Telehealth Palliative Care: Caregiver | In-person Palliative Care: Caregiver | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 10.9 | 65.5 years STANDARD_DEVIATION 10.6 | 56.8 years STANDARD_DEVIATION 14.8 | 58.0 years STANDARD_DEVIATION 13.2 | 63.0 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 30 Participants | 10 Participants | 14 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 596 Participants | 575 Participants | 255 Participants | 255 Participants | 1681 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 12 Participants | 7 Participants | 7 Participants | 34 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 4 Participants | 2 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian | 32 Participants | 32 Participants | 9 Participants | 12 Participants | 85 Participants |
| Race/Ethnicity, Customized Black or African American | 57 Participants | 72 Participants | 17 Participants | 22 Participants | 168 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 0 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 10 Participants | 7 Participants | 2 Participants | 40 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 3 Participants | 6 Participants | 1 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 524 Participants | 502 Participants | 238 Participants | 235 Participants | 1499 Participants |
| Region of Enrollment United States | 633 participants | 617 participants | 272 participants | 276 participants | 1798 participants |
| Sex/Gender, Customized Man | 277 Participants | 297 Participants | 90 Participants | 82 Participants | 746 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Woman | 356 Participants | 318 Participants | 182 Participants | 194 Participants | 1050 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 365 / 633 | 368 / 617 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Patient-reported Quality of Life
Compare the difference between study groups in patient-reported quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better overall quality of life.
Time frame: 24 Weeks
Population: The analysis population represents the numbers of patients in each study group who completed the baseline and 24-week Functional Assessment of Cancer Therapy - Lung Questionnaire.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Telehealth Palliative Care: Patients | Patient-reported Quality of Life | 99.7 units on a scale |
| In-person Palliative Care: Patients | Patient-reported Quality of Life | 97.7 units on a scale |
Comparison: The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.p-value: 0.0490% CI: [0.1, 3.9]Regression, Linear
Secondary
Caregiver-reported Satisfaction With Care
Compare the difference between study groups in caregiver-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire (caregiver version), which has a total scale score range from 0-48 with higher scores indicating greater satisfaction.
Time frame: 24 weeks
Population: The analysis population represents the numbers of caregivers in each study group who completed the 24-week Satisfaction and Care Delivery Questionnaire.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Telehealth Palliative Care: Patients | Caregiver-reported Satisfaction With Care | 37.2 units on a scale |
| In-person Palliative Care: Patients | Caregiver-reported Satisfaction With Care | 36.8 units on a scale |
Comparison: The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.p-value: >0.9995% CI: [-1.5, 2.3]Regression, Linear
Secondary
Length of Stay in Hospice
Compare the difference between study groups in the length of stay in hospice (as measured in days) among patients who died during study period per medical record review.
Time frame: From hospice enrollment until patient death during study period
Population: The analysis population represents the numbers of patients in each study group who who died during the study period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Telehealth Palliative Care: Patients | Length of Stay in Hospice | 25.3 days |
| In-person Palliative Care: Patients | Length of Stay in Hospice | 25.1 days |
Comparison: The difference in mean length of stay in hospice between groups was estimated using a linear regression model with a main effect for group assignment.p-value: 0.4690% CI: [-7, 7.4]Regression, Linear
Secondary
Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians
Compare the difference between study groups in the proportion of patients who reported that they discussed their end-of-life care preferences with their clinicians based on a single item from the Prognosis and Treatment Perceptions Questionnaire (PTPQ). The PTPQ includes a self-report item that assesses whether the patient communicated with their clinicians about their wishes for care if they were dying (i.e., scored dichotomously as yes vs. no).
Time frame: 48 weeks (or last assessment prior to death if before 48 weeks)
Population: The analysis population represents the numbers of patients in each study group who completed the Prognosis and Treatment Perceptions Questionnaire at least once post baseline up to 48 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Palliative Care: Patients | Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians | 130 Participants |
| In-person Palliative Care: Patients | Patient-reported Communication About Their End-of-Life Care Preferences With Their Clinicians | 115 Participants |
Comparison: The difference between groups in the proportions of patients reporting that they communicated with their clinicians about their end-of-life care preferences was estimated using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.p-value: 0.2690% CI: [-1.8, 8.1]binomial generalized estimating equation
Secondary
Patient-reported Satisfaction With Care
Compare the difference between study groups in patient-reported satisfaction with care as measured by the Satisfaction and Care Delivery Questionnaire, which has a total scale score range from 0-52 with higher scores indicating greater satisfaction.
Time frame: 24 weeks
Population: The analysis population represents the numbers of patients in each study group who completed the 24-week Satisfaction and Care Delivery Questionnaire.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Telehealth Palliative Care: Patients | Patient-reported Satisfaction With Care | 41.3 units on a scale |
| In-person Palliative Care: Patients | Patient-reported Satisfaction With Care | 41.0 units on a scale |
Comparison: The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.p-value: >0.9995% CI: [-1, 1.7]Regression, Linear
Secondary
Proportion of Patient's Palliative Care Visits With a Caregiver Present
Compare the difference between study groups in the proportion of palliative care visits that had a caregiver present as documented by the palliative care clinician using a study visit summary form.
Time frame: 24 weeks
Population: The analysis population represents the numbers of patients in each study group who had any palliative care visits, and the overall number of units analyzed represents the numbers of palliative care visits in each study group through week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Palliative Care: Patients | Proportion of Patient's Palliative Care Visits With a Caregiver Present | 36.6 proportion of visits with a caregiver |
| In-person Palliative Care: Patients | Proportion of Patient's Palliative Care Visits With a Caregiver Present | 49.7 proportion of visits with a caregiver |
Comparison: The proportion of palliative care visits with caregiver participation was compared using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.p-value: <0.00195% CI: [-17.6, -8.6]binomial generalized estimating equation
Other Pre-specified
Caregiver-reported Mood Symptoms
Compare the difference between study groups in caregiver-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).
Time frame: up to 48 weeks
Other Pre-specified
Caregiver-reported Prognostic Understanding
Compare the difference between study groups in caregiver-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which caregivers rate two items about the goal of their loved one's cancer care (i.e., scored dichotomously as either to cure his/her cancer vs any other option) and whether their loved one's cancer is curable (i.e., scored dichotomously as yes or no).
Time frame: up to 48 weeks
Other Pre-specified
Caregiver-reported Quality of Life
Compare the difference between study groups in caregiver-reported quality of life as measured by the Caregiver Oncology Quality of Life Questionnaire, which has a total scale score range of 0-100 with higher scores indicating better quality of life.
Time frame: up to 48 weeks
Other Pre-specified
Caregiver-reported Quality of Patient Death
Compare the difference between study groups in caregiver-reported quality of patient death as measured by the After Death Assessment, which includes three items that ask the caregiver to rate the quality of the patient's death (from 1 worst possible to 10 best possible), the degree of physical distress the patient experienced in their last week of life (from 1 none to 10 extremely distressed), and the degree of psychological distress the patient experienced in their last week of life (from 1 none to 10 extremely upset).
Time frame: Up to 6 months after patient death during study period
Other Pre-specified
Health Care Utilization
Compare the difference between study groups in health care utilization as per medical record review of emergency department visits, hospital admissions, chemotherapy administration at the end of life, and hospice service use.
Time frame: Through study completion, average of 18 month follow up
Other Pre-specified
Patient-reported Coping Strategies
Compare the difference between study groups in patient-reported coping strategies as measured by the Brief Cope (approach-oriented coping score range: 6-24, with higher scores indicating greater use of approach-oriented coping strategies; avoidant coping score range: 4-16, with higher scores indicating greater use of avoidant coping strategies).
Time frame: up to 48 weeks
Other Pre-specified
Patient-reported Depression
Compare the difference between study groups in patient-reported depression as measured by the Patient Health Questionnaire-9, which has a total scale score range from 0-27 with higher scores indicating more significant depression symptoms.
Time frame: up to 48 weeks
Other Pre-specified
Patient-reported Mood Symptoms
Compare the difference between study groups in patient-reported mood symptoms as measured by the Hospital Anxiety and Depression Scale (anxiety subscale score range, 0-21, with higher scores indicating greater anxiety symptoms; depression subscale score range, 0-21, with higher scores indicating greater depression symptoms).
Time frame: up to 48 weeks
Other Pre-specified
Patient-reported Prognostic Understanding
Compare the difference between study groups in patient-reported prognostic understanding as measured by the Prognosis and Treatment Perceptions Questionnaire, in which patients rate two items about the goal of their cancer care (i.e., scored dichotomously as either to cure my cancer vs any other option) and whether their cancer is curable (i.e., scored dichotomously as yes or no).
Time frame: up to 48 weeks
Other Pre-specified
Patient-reported Quality of Life
Compare the difference between study groups in patient-reported quality of life across all study assessment time points as measured by the Functional Assessment of Cancer Therapy - Lung Questionnaire, which has a total scale score range from 0-136 with higher scores indicating better quality of life.
Time frame: up to 48 weeks