Journal of geriatric oncology · 2025
A pragmatic randomized controlled trial of nurse-delivered brief Meaning Centered Psychotherapy at Home (MCP-H) for individuals with advanced cancer: Study protocol.
СтатьяПротокол клинического исследованияПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Saracino Rebecca M, Park Ellen Y, Onorato Nicole, Pessin Hayley, McDonald Margaret, Demirjian Caraline, Schofield Elizabeth, Rosenfeld Barry, Breitbart William, Applebaum Allison J
Аннотация
INTRODUCTION: Patients with advanced cancer are often confronted with existential distress that, when unaddressed, may lead to increased suffering and despair. Homebound individuals face compounded existential concerns and loss of meaning, as they must contend with loss of independence and declining opportunities for activities and social engagement. Thus, there is a need to develop strategies for delivering quality psychological interventions to homebound patients. In the United States, homecare agencies provide care to over 4.5 million patients annually, with nurses comprising over half of their employees. Given the size of this workforce and their frequent contact with homebound patients, we developed Meaning Centered Psychotherapy at Home (MCP-H) to be delivered by nurses to increase the reach of this evidence-based intervention to this population.
MATERIALS AND METHODS: In Phase 1, nurse participants (n = 8-10) from VNS Health will be trained to deliver MCP-H. We will enroll 8-10 training case patients, each paired with one nurse interventionist, in a single-arm open pilot study to refine the intervention structure and procedures. In Phase 2, we will conduct a pilot randomized controlled trial to determine the feasibility, acceptability, and preliminary efficacy of MCP-H. Patients (n = 70) will be randomized to receive either MCP-H or treatment as usual.
DISCUSSION: MCP-H has unique potential to increase the reach of mental health care to individuals receiving homecare, leveraging the existing infrastructure of a high-volume home health agency and nurses to address the unmet needs of these patients. If effective, it can be embedded in existing systems as a potentially widely disseminable approach to reaching historically underserved patient populations.
TRIAL REGISTRATION: This study is registered under ClinicalTrials.gov (ID NCT05495737).
MATERIALS AND METHODS: In Phase 1, nurse participants (n = 8-10) from VNS Health will be trained to deliver MCP-H. We will enroll 8-10 training case patients, each paired with one nurse interventionist, in a single-arm open pilot study to refine the intervention structure and procedures. In Phase 2, we will conduct a pilot randomized controlled trial to determine the feasibility, acceptability, and preliminary efficacy of MCP-H. Patients (n = 70) will be randomized to receive either MCP-H or treatment as usual.
DISCUSSION: MCP-H has unique potential to increase the reach of mental health care to individuals receiving homecare, leveraging the existing infrastructure of a high-volume home health agency and nurses to address the unmet needs of these patients. If effective, it can be embedded in existing systems as a potentially widely disseminable approach to reaching historically underserved patient populations.
TRIAL REGISTRATION: This study is registered under ClinicalTrials.gov (ID NCT05495737).