Patient-centered, Optimal Integration of Survivorship and Palliative Care

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Patient-centered, Optimal Integration of Survivorship and Palliative Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900935
• Other study ID #: 20-722
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: May 1, 2027

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Laura A Petrillo, MD
• Phone: (617) 724-4000
• Email: lpetrillo2[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 90 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 80 patients in a randomized controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK-positive Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• EGFR Positive Non-small Cell Lung Cancer
• Lung Neoplasms
• Nonsmall Cell Lung Cancer
• Palliative Care
• Stage IV Non-small Cell Lung Cancer
• Survivorship
• Targeted Therapy

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 weeks
Other	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.	20 weeks
Other	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.	12 weeks
Other	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.	20 weeks
Primary	Feasibility of POISE	At least 60% enrollment among eligible patients and 75% completion of all four sessions	20 Weeks
Secondary	Acceptability	>70% of patients reporting that they agree or strongly agree with the four measures of satisfaction and comfort with the intervention	20 Weeks
Secondary	Distress related to prognostic uncertainty	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.	12 weeks
Secondary	Distress related to prognostic uncertainty	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.	20 weeks
Secondary	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).	12 weeks
Secondary	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	20 weeks
Secondary	Documentation of Goals and Values	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.	20 weeks