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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05495737
Other study ID # 22-019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 8, 2022
Est. completion date August 8, 2024

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact Rebecca Saracino, PhD
Phone 646-888-0263
Email jamesr@mskcc.org
Is FDA regulated No
Health authority
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 80
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

Study Design


Related Conditions & MeSH terms


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
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