STEP PC: Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
Study Details
Study Description
Brief Summary
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Other: 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
|
| Experimental: 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 |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Establish that stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L [24 Weeks]
Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung
Secondary Outcome Measures
- Assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about EOL care preferences [up to 5 years]
Communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying
- Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice [up to 5 years]
Length of stay in hospice as collected per medical record review
- Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization [up to 5 years]
Utilization of PC services as per medical record review
- Evaluate whether stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L [up to 48 weeks]
Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung
Other Outcome Measures
- Compare the superiority of stepped PC versus early integrated PC with respect to cost effectiveness [up to 5 years]
Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL
- Compare patients' coping as measured by the Brief Cope between stepped PC and early integrated PC [up to 48 weeks]
Coping as measured by the Brief Cope
- Compare patients' prognostic understanding as measured by the Perception of Treatment and Prognosis Questionnaire between stepped PC and early integrated PC [up to 48 weeks]
Prognostic understanding as per the Perception of Treatment and Prognosis Questionnaire (PTPQ)
- Compare patients' depression as measured by the Patient Health Questionnaire-9 (PHQ-9) between stepped PC and early integrated PC [up to 48 weeks]
Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)
Eligibility Criteria
Criteria
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)
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The ability to read and respond to questions in English or Spanish
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Primary cancer care at one of the three participating sites
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Age > 18 years
Exclusion Criteria:
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Already receiving outpatient PC or hospice services
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Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Duke University | Durham | North Carolina | United States | 27710 |
| 3 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-471
- R01CA215188