Lung Cancer
Conditions
Keywords
Lung Cancer
Brief summary
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
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 their 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 family 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 your 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 may have better symptom control, quality of life, and mood and their loved ones feel less distressed. This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care". The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment. No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.
Interventions
OTHERStepped PC
Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer
OTHEREarly Integrated PC
Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
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
* Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, 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 2 (symptomatic and in bed \<50% of the day) * The ability to read and respond to questions in English or Spanish * Primary cancer care at one of the three participating sites * Age \> 18 years
Exclusion criteria
* Already receiving outpatient PC or hospice services * Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Quality of Life | 24 Weeks | Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians | 48 weeks (or last assessment prior to death if before 48 weeks) | Compare the proportion of patients who report that they discussed their end-of-life care preferences with their clinicians based on a single item from the perceptions of prognosis and treatment questionnaire (PTPQ). The PTPQ includes an item that measures patient report of communication about their wishes if they were dying (yes vs. no). |
| Length of Stay in Hospice | From hospice enrollment until death during study period (i.e. 12-month follow up) | Length of stay in hospice as collected per medical record review |
| Palliative Care Resource Utilization | week 24 | Mean number of palliative care visits |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Temel, MD
Massachusetts General Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stepped PC * Patients will receive Stepped PC
* During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment
* Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will step up to step 2 of the protocol
* Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness
Stepped PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer | 250 |
| Early Integrated PC * Patients will receive Early Integrated PC
* Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness
Early Integrated PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer | 257 |
| Total | 507 |
Baseline characteristics
| Characteristic | Stepped PC | Early Integrated PC | Total |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 9.2 | 66.1 years STANDARD_DEVIATION 11.1 | 66.5 years STANDARD_DEVIATION 10.2 |
| Functional Assessment of Cancer Therapy - Lung | 93.6 units on a scale STANDARD_DEVIATION 19.4 | 95.7 units on a scale STANDARD_DEVIATION 19.7 | 94.63 units on a scale STANDARD_DEVIATION 19.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 28 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) White | 215 Participants | 212 Participants | 427 Participants |
| Region of Enrollment United States | 250 participants | 257 participants | 507 participants |
| Sex/Gender, Customized Man | 120 participants | 126 participants | 246 participants |
| Sex/Gender, Customized Missing | 0 participants | 1 participants | 1 participants |
| Sex/Gender, Customized Other | 0 participants | 0 participants | 0 participants |
| Sex/Gender, Customized Woman | 130 participants | 130 participants | 260 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 161 / 250 | 164 / 257 |
| 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
Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life
Time frame: 24 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stepped PC | Patient-reported Quality of Life | 100.62 score on a scale |
| Early Integrated PC | Patient-reported Quality of Life | 97.75 score on a scale |
Comparison: The difference in week 24 means between groups was estimated using a linear regression model adjusted for baseline FACT-L score.p-value: <0.05Regression, Linear
Secondary
Length of Stay in Hospice
Length of stay in hospice as collected per medical record review
Time frame: From hospice enrollment until death during study period (i.e. 12-month follow up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped PC | Length of Stay in Hospice | 19.5 days | Standard Deviation 4.3 |
| Early Integrated PC | Length of Stay in Hospice | 34.6 days | Standard Deviation 4.2 |
Comparison: Among patients who died, non-inferiority of stepped PC in the mean length of stay in hospice was assessed using linear regression and a one-sided test against the pre-specified margin of -7 days, based upon published quality metrics.p-value: 0.15Regression, Linear
Secondary
Palliative Care Resource Utilization
Mean number of palliative care visits
Time frame: week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped PC | Palliative Care Resource Utilization | 2.4 days | Standard Deviation 0.2 |
| Early Integrated PC | Palliative Care Resource Utilization | 4.7 days | Standard Deviation 0.1 |
Comparison: The difference between groups in the mean number of outpatient PC visits per patient by week 24 was assessed using linear regression and a two-sided superiority test.p-value: 0.1595% CI: [-2.7, -1.8]Regression, Linear
Secondary
Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians
Compare the proportion of patients who report that they discussed their end-of-life care preferences with their clinicians based on a single item from the perceptions of prognosis and treatment questionnaire (PTPQ). The PTPQ includes an item that measures patient report of communication about their wishes if they were dying (yes vs. no).
Time frame: 48 weeks (or last assessment prior to death if before 48 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stepped PC | Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians | 58 Participants |
| Early Integrated PC | Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians | 62 Participants |
Comparison: Non-inferiority of stepped PC in the proportion reporting patient-clinician communication about end-of-life care at each patient's final follow-up assessment was evaluated using a binomial generalized linear model with identity link and a one-sided test against the pre-specified margin of -10%.p-value: <0.15Regression, Linear
Other Pre-specified
Cost-effectiveness
Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL
Time frame: up to 5 years
Other Pre-specified
Health Care Utilization
Healthcare utilization as measured the means and proportion of patients who experience emergency department visits, hospital admission, and chemotherapy administration at the end of life between the two groups.
Time frame: prior to death or end of study period
Other Pre-specified
Patients' Prognostic Understanding
Perception of Treatment and Prognosis Questionnaire (PTPQ)
Time frame: last assessment collected during study or prior to death