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NCT Number: NCT04900935

Patient-centered, Optimal Integration of Survivorship and Palliative Care

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.

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Key information

Conditions

Stage IV Non-small Cell Lung Cancer ALK-positive Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Positive Non-small Cell Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nonsmall Cell Lung Cancer Palliative Care Respiratory Tract Diseases Respiratory Tract Neoplasms Survivorship Targeted Therapy Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Laura A. Petrillo, MD

CONTACT

[email protected]

617-724-4000

Laura A. Petrillo, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POISE

Behavioral

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: palliative care intervention

Primary outcomes

  1. Feasibility of POISE - enrollment

    Time frame: 20 weeks

    ≥60% enrollment among eligible patientsamong patients in the POISE group

  2. Feasibility of POISE - completion of all sessions among patients in intervention group

    Time frame: 20 weeks

    ≥70% completion of all sessions in the intervention arm

  3. Feasibility of POISE - completion of surveys in both arms

    Time frame: 20 weeks

    ≥70% completion of all surveys in both arms

Secondary outcomes

  1. Acceptability

    Time frame: 20 Weeks

    4-item measure of satisfaction and comfort with the intervention

  2. Emotional coping with prognosis and prognostic awareness

    Time frame: 12 weeks

    Subscale of Prognostic Awareness Impact Scale

  3. Emotional coping with prognosis and prognostic awareness

    Time frame: 20 weeks

    Subscale of Prognostic Awareness Impact Scale

  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: 20 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: 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 outcomes

  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: 20 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: 20 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.

  5. Multidimensional quality of life

    Time frame: 12 weeks

    Functional Assessment of Cancer Therapy-Lung, a quality of life measure

  6. Multidimensional quality of life

    Time frame: 20 weeks

    Functional Assessment of Cancer Therapy-Lung, a quality of life measure

  7. Hope and goal setting

    Time frame: 12 weeks

    Adult Trait Hope Scale

  8. Hope and goal setting

    Time frame: 20 weeks

    Adult Trait Hope Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Laura A Petrillo, MD

CONTACT

[email protected]

(617) 724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 25, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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