Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 510
- Locations
- 3
- Primary Endpoint
- Patient-reported Quality of Life
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Jennifer Temel, MD
Principal Investigator
Massachusetts General Hospital
Eligibility 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)
- •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
Outcomes
Primary Outcomes
Patient-reported Quality of Life
Time Frame: 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 Outcomes
- 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))
- Palliative Care Resource Utilization(week 24)
- Length of Stay in Hospice(From hospice enrollment until death during study period (i.e. 12-month follow up))