ALK-positive Non-small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, EGFR Positive Non-small Cell Lung Cancer, Nonsmall Cell Lung Cancer, Palliative Care, Stage IV Non-small Cell Lung Cancer, Survivorship, Targeted Therapy
Conditions
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
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.
Interventions
BEHAVIORALPOISE
POISE (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.
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking of participants and care providers is not possible in this clinical intervention. However, we will mask the outcomes assessor to minimize bias.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of POISE - enrollment | 20 weeks | ≥60% enrollment among eligible patientsamong patients in the POISE group |
| Feasibility of POISE - completion of surveys in both arms | 20 weeks | ≥70% completion of all surveys in both arms |
| Feasibility of POISE - completion of all sessions among patients in intervention group | 20 weeks | ≥70% completion of all sessions in the intervention arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotional coping with prognosis and prognostic awareness | 12 weeks | Subscale of Prognostic Awareness Impact Scale |
| Acceptability | 20 Weeks | 4-item measure of satisfaction and comfort with the intervention |
| Self efficacy | 12 weeks | 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). |
| Documentation of Goals and Values | 20 weeks | The investigators will apply a previously developed natural language processing/machine learning (ML) algorithm to palliative care and oncology notes from the study period in order to identify goals of care conversations using an inductive supervised ML classifier. Notes with a predicted probability of greater than 0.5 will be classified as containing goals of care documentation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress | 12 weeks | 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. |
| Hope and goal setting | 12 weeks | Adult Trait Hope Scale |
| Uncertainty tolerance | 12 weeks | 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. |
| Multidimensional quality of life | 12 weeks | Functional Assessment of Cancer Therapy-Lung, a quality of life measure |
Countries
United States
Contacts
Primary ContactLaura A Petrillo, MD
Outcome results
None listed