Meaning-Centered Psychotherapy at Home

Nurse-Patient Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495737
• Other study ID #: 22-019
• Status: Recruiting
• Start date: August 8, 2022
• Est. completion date: August 8, 2024

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Rebecca Saracino, PhD
• Phone: 646-888-0263
• Email: jamesr[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 8, 2024
• Est. primary completion date: August 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nurse-Patient Relations
• Psychology, Social

Intervention

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
• Meaning-Centered Psychotherapy/MCP-PC
3 sessions, completed over the course of 3-6 weeks in the participant's home
• Treatment As Usual/TAU
Research team will provide: feedback about level of distress at time of screening local referral for psychological care

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Visiting Nurse Service of NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center