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Patient-centered, Optimal Integration of Survivorship and Palliative Care

Primary Purpose

Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POISE
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Non-small Cell Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

POISE

Usual care

Arm Description

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 20-week post-enrollment Four 60-minute visits with a trained palliative care clinician Semi-structured exit interview Chart review

Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.

Outcomes

Primary Outcome Measures

Feasibility of POISE
At least 60% enrollment among eligible patients and 75% completion of all four sessions

Secondary Outcome Measures

Acceptability
>70% of patients reporting that they agree or strongly agree with the four measures of satisfaction and comfort with the intervention
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.
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.
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).
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
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.

Full Information

First Posted
May 20, 2021
Last Updated
October 20, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04900935
Brief Title
Patient-centered, Optimal Integration of Survivorship and Palliative Care
Official Title
Patient-centered, Optimal Integration of Survivorship and Palliative Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POISE
Arm Type
Experimental
Arm Description
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 20-week post-enrollment Four 60-minute visits with a trained palliative care clinician Semi-structured exit interview Chart review
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.
Intervention Type
Behavioral
Intervention Name(s)
POISE
Other Intervention Name(s)
palliative care intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of POISE
Description
At least 60% enrollment among eligible patients and 75% completion of all four sessions
Time Frame
20 Weeks
Secondary Outcome Measure Information:
Title
Acceptability
Description
>70% of patients reporting that they agree or strongly agree with the four measures of satisfaction and comfort with the intervention
Time Frame
20 Weeks
Title
Distress related to prognostic uncertainty
Description
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.
Time Frame
12 weeks
Title
Distress related to prognostic uncertainty
Description
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.
Time Frame
20 weeks
Title
Self efficacy
Description
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).
Time Frame
12 weeks
Title
Self efficacy
Description
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
Time Frame
20 weeks
Title
Documentation of Goals and Values
Description
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.
Time Frame
20 weeks
Other Pre-specified Outcome Measures:
Title
Uncertainty tolerance
Description
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.
Time Frame
12 weeks
Title
Uncertainty tolerance
Description
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.
Time Frame
20 weeks
Title
Psychological Distress
Description
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.
Time Frame
12 weeks
Title
Psychological Distress
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura A Petrillo, MD
Phone
(617) 724-4000
Email
lpetrillo2@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Petrillo, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura A. Petrillo, MD
Phone
617-724-4000
Email
lpetrillo2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Laura A. Petrillo, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

Patient-centered, Optimal Integration of Survivorship and Palliative Care

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