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.
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
Cognitive impairment or serious mental illness that limits ability to provide informed consent
Need for urgent palliative care or hospice referral
Pregnant women
Prisoners
Parallel
POISE
BehavioralPOISE (Patient-centered, Optimal Integration of Survivorship and palliative carE) is a brief, population-specific intervention that consists 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 long, uncertain cancer trajectories.
Feasibility of POISE - enrollment
≥60% enrollment among eligible patientsamong patients in the POISE group
Feasibility of POISE - completion of all sessions among patients in intervention group
≥70% completion of all sessions in the intervention arm
Feasibility of POISE - completion of surveys in both arms
≥70% completion of all surveys in both arms
Acceptability
4-item measure of satisfaction and comfort with the intervention
Emotional coping with prognosis and prognostic awareness
Subscale of Prognostic Awareness Impact Scale
Emotional coping with prognosis and prognostic awareness
Subscale of Prognostic Awareness Impact Scale
Self efficacy
Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale, ranging from 1 (not at all confident) to 10 (totally confident).
Uncertainty tolerance
Intolerance of Uncertainty-Short Form is a 12-item questionnaire with descriptions about ability to tolerate uncertainty, using a Likert scale of agreement from 1 to 5, with lower scores indicating low intolerance of uncertainty and high scores indicating high intolerance of uncertainty.
Uncertainty tolerance
Intolerance of Uncertainty-Short Form is a 12-item questionnaire with descriptions about ability to tolerate uncertainty, using a Likert scale of agreement from 1 to 5, with lower scores indicating low intolerance of uncertainty and high scores indicating high intolerance of uncertainty.
Psychological Distress
Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week, with higher scores indicating worse anxiety and depression.
Psychological Distress
Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week, with higher scores indicating worse anxiety and depression.
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
