Meaning-Centered Psychotherapy at Home

October 31, 2023 updated by: Memorial Sloan Kettering Cancer Center

A Pragmatic Randomized Control Trial of Nurse-Delivered Brief Meaning Centered Psychotherapy for Homebound Palliative Care Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rebecca Saracino, PhD
  • Phone Number: 646-888-0263
  • Email: jamesr@mskcc.org

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Rebecca Saracino, PhD
          • Phone Number: 646-888-0263
      • New York, New York, United States, 10021
        • Recruiting
        • Visiting Nurse Service of NY
        • Contact:
          • Margaret McDonald, MSW
          • Phone Number: 646-888-0263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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

Description

Participant Inclusion Criteria:

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:

  1. 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)
  2. What is your preferred language for healthcare? (must respond English)

Participant Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1: Nurse Participants
n=8-10 nurses
Behavioral: Meaning-Centered Psychotherapy/MCP-PC Training
Two-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment
Phase 1: Patient Participants
n=8-10 patients
Behavioral: Meaning-Centered Psychotherapy/MCP-PC
3 sessions, completed over the course of 3-6 weeks in the participant's home
Phase 2: Nurse Participants
n=8-10 nurses
Behavioral: Meaning-Centered Psychotherapy/MCP-PC Training
Two-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment
Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm
n=30
Behavioral: Meaning-Centered Psychotherapy/MCP-PC
3 sessions, completed over the course of 3-6 weeks in the participant's home
Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm
n=30
Behavioral: Treatment As Usual/TAU

Research team will provide:

  1. feedback about level of distress at time of screening
  2. local referral for psychological care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MPI Competency Ratings
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Rebecca Saracina, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Estimated)

August 8, 2024

Study Completion (Estimated)

August 8, 2024

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychology, Social

Clinical Trials on Meaning-Centered Psychotherapy/MCP-PC Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe