Clinical trial NCT03220100: Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
Official title: Pilot Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating a new way to provide palliative care to patients who have recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.

Detailed description: Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. Both patients and their families often feel worried and/or sad about this 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 serious illnesses, improves patients' quality of life and mood, and can help their loved ones' feel less depressed or sad. This team is called "palliative care," and consists of physicians and advanced practice nurses who work closely and collaboratively with the oncology team to care for the patient and their loved ones.

While the investigators know having palliative care clinicians care for patients along with their oncology team is helpful for the participant and their loved ones, the investigators do not know the optimal timing of the visits with palliative care.

The purpose of this study is to see if the investigators can closely monitor participants' health condition and quality of life and use these metrics as indications of when the participant should see the palliative care team.

This study will monitor participants' health condition and schedule the participant to see the palliative care team if the participants' cancer grows or after the participant have been admitted to the hospital. The investigators will also monitor participants' quality of life every six weeks and schedule the participant to see the palliative care monthly if the participant quality of life decreases during the study.

This study will also monitor participants' mood, coping, and understanding of the participant illness and prognosis. The investigators will ask the participant to fill out questionnaires asking about these topics every 12 weeks. The participant will be able to complete these questionnaires in clinic, via email, using a mailed paper copy, or over the phone with a member of the research team.

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 eight 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 with minimal help from a family member or medical interpreter.
* Primary cancer care at the MGH Cancer Center
* Age \> 18 years

Exclusion Criteria:

* They are already receiving PC or hospice services
* They have cognitive or psychiatric conditions as determined by the treating oncologist that prohibits study consent or participation

Primary outcomes:
measure: Proportion of participants who complete the study protocol
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References: