Patient-centered, Optimal Integration of Survivorship and Palliative Care
Study Details
Study Description
Brief Summary
This study is being conducted to develop a supportive care model for patients with metastatic Non-small Cell Lung Cancer (NSCLC) to learn to cope with uncertainty and help them understand their prognosis and the goal of therapy, in order to live well with cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Four 60-minute visits with a trained palliative care clinician
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Questionnaires and an exit interview
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Chart Review
It is expected that about 15 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: POISE The intervention will be a structured palliative care intervention in which patients will meet with a palliative care clinician who has been trained on a manual with specific topics to be covered in each of the four visits: Three surveys: baseline, 12-week, and 24-week post-enrollment Four 60-minute visits with a trained palliative care clinician Semi-structured exit interview Chart review |
Behavioral: POISE
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Rate of acceptability at 24 weeks [24 Weeks]
Acceptability as ≥70% of patients reporting favorable responses to the acceptability questions (e.g., "right amount" of visits and time per visit, helpful, probably or definitely recommend the intervention)
Secondary Outcome Measures
- Rate of acceptability at 12 weeks [12 Weeks]
Acceptability as ≥70% of patients reporting favorable responses to the acceptability questions (e.g., "right amount" of visits and time per visit, helpful, probably or definitely recommend the intervention)
- Distress related to prognostic uncertainty [12 weeks]
5-item scale with questions such as, "I am able to cope with the uncertainties about my prognosis," using a 4-point Likert scale of agreement.
- Distress related to prognostic uncertainty [24 weeks]
5-item scale with questions such as, "I am able to cope with the uncertainties about my prognosis," using a 4-point Likert scale of agreement.
- 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).
- Self efficacy [24 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
- Documentation of Goals and Values [24 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 Outcome Measures
- 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.
- Uncertainty tolerance [24 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.
- 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.
- Psychological Distress [24 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or older
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MGH Cancer Center patient
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Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)
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Receiving targeted therapy
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Ability to respond in English or Spanish
Exclusion Criteria:
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Cognitive impairment or serious mental illness that limits ability to provide informed consent
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Need for urgent palliative care or hospice referral
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Pregnant women
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Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Massachusetts General Hospital
- American Lung Association
Investigators
- Principal Investigator: Laura A Petrillo, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-722