Clinical trial NCT04900935: Patient-centered, Optimal Integration of Survivorship and Palliative Care
Official title: Patient-centered, Optimal Integration of Survivorship and Palliative Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage IV Non-small Cell Lung Cancer
Targeted Therapy
Nonsmall Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
ALK-positive Non-small Cell Lung Cancer
EGFR Positive Non-small Cell Lung Cancer
Palliative Care
Survivorship
Keywords: Stage IV Non-small Cell Lung Cancer
Targeted Therapy
Nonsmall Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
ALK-positive Non-small Cell Lung Cancer
EGFR Positive Non-small Cell Lung Cancer
ROS1 Positive Non-Small Cell Lung Cancer
Palliative care
survivorship
RET Fusion positive Non-Small Cell Lung Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two phases of this research study: 1) an open pilot of 10 patients to refine the intervention and study protocol, in which all patients receive the POISE intervention; followed by 2) a randomized controlled trial in which patients are randomized to receive either the POISE intervention or usual care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are

* is POISE feasible to deliver and acceptable to patients
* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.

Detailed description: This research study involves an intervention consisting of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with NSCLC.

The research study procedures include:

* Four 60-minute visits with a trained palliative care clinician
* Questionnaires and an exit interview
* Chart Review

It is expected that about 70 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study: 10 patients in an open pilot study, followed by 60 patients in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* MGH Cancer Center patient
* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)
* Receiving targeted therapy
* Ability to respond in English or Spanish

Exclusion Criteria:

* Cognitive impairment or serious mental illness that limits ability to provide informed consent
* Need for urgent palliative care or hospice referral
* Pregnant women
* Prisoners

Primary outcomes:
measure: Feasibility of POISE
timeFrame: 20 Weeks
Secondary outcomes:
measure: Acceptability
timeFrame: 20 Weeks
measure: Distress related to prognostic uncertainty
timeFrame: 12 weeks
measure: Distress related to prognostic uncertainty
timeFrame: 20 weeks
measure: Self efficacy
timeFrame: 12 weeks
measure: Self efficacy
timeFrame: 20 weeks
measure: Documentation of Goals and Values
timeFrame: 20 weeks
Other outcomes:
measure: Uncertainty tolerance
timeFrame: 12 weeks
measure: Uncertainty tolerance
timeFrame: 20 weeks
measure: Psychological Distress
timeFrame: 12 weeks
measure: Psychological Distress
timeFrame: 20 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Laura A Petrillo, MD
role: PRINCIPAL_INVESTIGATOR
References: