Meaning-Centered Psychotherapy at Home
A Pragmatic Randomized Control Trial of Nurse-Delivered Brief Meaning Centered Psychotherapy for Homebound Palliative Care Patients
1 other identifier
observational
81
1 country
2
Brief Summary
The purpose of this study is to train nurses from the VNS Health Visiting Nurse Service to deliver Meaning-Centered Psychotherapy for Palliative Care Patients (MCP-PC) to homebound people, and to evaluate how effective MCP-PC is for people with cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2022
CompletedStudy Start
First participant enrolled
August 8, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 8, 2026
September 10, 2025
September 1, 2025
4 years
August 8, 2022
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MPI Competency Ratings
Phase I portion: To refine the MCP-PC training and study procedures for homecare delivery by nurse interventionists as determined by providers' MPI Competency Ratings
2 years
Study Arms (5)
Phase 1: Nurse Participants
n=8-10 nurses
Phase 1: Patient Participants
n=8-10 patients
Phase 2: Nurse Participants
n=8-10 nurses
Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm
n=35
Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm
n=35
Interventions
Two-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment
3 sessions, completed over the course of 3-6 weeks in the participant's home
Research team will provide: 1. feedback about level of distress at time of screening 2. local referral for psychological care
Eligibility Criteria
Both patients and homecare nurses will be recruited and enrolled as participants in the proposed study. All participants will be recruited from VNS Health Visiting Nurse Service
You may qualify if:
- Nurses (all phases):
- Per self-report, providing direct care services at VNS Health
- Per self-report, fluent in English\*\*
- Per self-report, is age 18 or older
- Patients (all phases):
- Per health record and/or self-report, is a patient in the VNS Health home health agency division (post-acute care)
- Per health record and/or self-report, is age 18 or older
- Per health record, has a cancer diagnosis and a rating of ≥ 2 on Symptom Control Scale
- Per health record and/or self-report, fluent in English\*\*
- Has a score of ≥ 4 on Callahan cognitive screener
- Has a score of ≥ 4 on Distress Thermometer (N/A for Training Case Participants)
- Language verification: For both nurses and patients, prior to enrollment, all will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify
- English fluency necessary for participation in the study:
- How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- What is your preferred language for healthcare? (must respond English)
You may not qualify if:
- Nurses (all phases):
- Per self-report, planning to leave position at VNS Health in the next 6 months
- Patients (all phases):
- Per health record and/or self-report, has a diagnosis of Alzheimer's, dementia, or other organic brain disorder and in the judgment of the PIs is unable to meaningfully participate.
- Per health record, has impaired decision-making capacity
- Per health record and/or self-report, is permanently placed in a nursing home
- Per health record and/or self-report, is currently receiving Hospice care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Visiting Nurse Service of NY
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Publications (1)
Saracino RM, Park EY, Onorato N, Pessin H, McDonald M, Demirjian C, Schofield E, Rosenfeld B, Breitbart W, Applebaum AJ. A pragmatic randomized controlled trial of nurse-delivered brief Meaning Centered Psychotherapy at Home (MCP-H) for individuals with advanced cancer: Study protocol. J Geriatr Oncol. 2025 Nov;16(8):102736. doi: 10.1016/j.jgo.2025.102736. Epub 2025 Oct 3.
PMID: 41045824DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Saracina, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2022
First Posted
August 10, 2022
Study Start
August 8, 2022
Primary Completion (Estimated)
August 8, 2026
Study Completion (Estimated)
August 8, 2026
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.