NCT05495737

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2022Aug 2026

First Submitted

Initial submission to the registry

August 8, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2026

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 8, 2022

Last Update Submit

September 9, 2025

Conditions

Keywords

Meaning Centered PsychotherapyMeaning Centered Psychotherapy for Palliative Patients22-019Memorial Sloan Kettering Cancer Center

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

Behavioral: Meaning-Centered Psychotherapy/MCP-PC Training

Phase 1: Patient Participants

n=8-10 patients

Behavioral: Meaning-Centered Psychotherapy/MCP-PC

Phase 2: Nurse Participants

n=8-10 nurses

Behavioral: Meaning-Centered Psychotherapy/MCP-PC Training

Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm

n=35

Behavioral: Meaning-Centered Psychotherapy/MCP-PC

Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm

n=35

Behavioral: Treatment As Usual/TAU

Interventions

Two-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment

Phase 1: Nurse ParticipantsPhase 2: Nurse Participants

3 sessions, completed over the course of 3-6 weeks in the participant's home

Phase 1: Patient ParticipantsPhase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm

Research team will provide: 1. feedback about level of distress at time of screening 2. local referral for psychological care

Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

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.

Related Links

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Rebecca Saracina, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

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.

Locations