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Patient-centered, Optimal Integration of Survivorship and Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04900935
Recruitment Status : Not yet recruiting
First Posted : May 25, 2021
Last Update Posted : April 20, 2022
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Laura Petrillo, M.D., Massachusetts General Hospital

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
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 Behavioral: POISE Not Applicable

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 15 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient-centered, Optimal Integration of Survivorship and Palliative Care
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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 Name: palliative care intervention




Primary Outcome Measures :
  1. Rate of acceptability at 24 weeks [ Time Frame: 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 :
  1. Rate of acceptability at 12 weeks [ Time Frame: 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)

  2. Distress related to prognostic uncertainty [ Time Frame: 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.

  3. Distress related to prognostic uncertainty [ Time Frame: 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.

  4. Self efficacy [ Time Frame: 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).

  5. Self efficacy [ Time Frame: 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

  6. Documentation of Goals and Values [ Time Frame: 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:
  1. Uncertainty tolerance [ Time Frame: 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.

  2. Uncertainty tolerance [ Time Frame: 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.

  3. Psychological Distress [ Time Frame: 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.

  4. Psychological Distress [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04900935


Contacts
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Contact: Laura A Petrillo, MD (617) 724-4000 lpetrillo2@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Contact: Laura A. Petrillo, MD    617-724-4000    lpetrillo2@mgh.harvard.edu   
Principal Investigator: Laura A. Petrillo, MD         
Sponsors and Collaborators
Massachusetts General Hospital
American Lung Association
Investigators
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Principal Investigator: Laura A Petrillo, MD Massachusetts General Hospital
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Responsible Party: Laura Petrillo, M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04900935    
Other Study ID Numbers: 20-722
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

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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
Keywords provided by Laura Petrillo, M.D., Massachusetts General Hospital:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms