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RecruitingInterventional

Patient-centered, Optimal Integration of Survivorship and Palliative Care

NCT ID: NCT04900935Sponsor: Massachusetts General HospitalLast updated: 2025-11-24

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 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.

Arms & interventions

  • BehavioralPOISE

    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.

Outcome measures

Primary

  • Feasibility of POISE - enrollment

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

    Time frame: 20 weeks

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

    ≥70% completion of all sessions in the intervention arm

    Time frame: 20 weeks

  • Feasibility of POISE - completion of surveys in both arms

    ≥70% completion of all surveys in both arms

    Time frame: 20 weeks

Secondary

  • Acceptability

    Time frame: 20 Weeks

  • Emotional coping with prognosis and prognostic awareness

    Time frame: 12 weeks

  • Emotional coping with prognosis and prognostic awareness

    Time frame: 20 weeks

  • Self efficacy

    Time frame: 12 weeks

  • Self efficacy

    Time frame: 20 weeks

  • Documentation of Goals and Values

    Time frame: 20 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115

Recruiting
Laura A. Petrillo, MD · Contact
Laura A. Petrillo, MD · Principal Investigator

References

  • Richard HA, Sarathy R, Rabideau DJ, Feldman J, Cartagena L, Patel H, Sequist LV, Park E, Jackson V, Greer JA, Temel JS, Petrillo LA. Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial. BMJ Open. 2025 Aug 13;15(8):e098075. doi: 10.1136/bmjopen-2024-098075.(PubMed)