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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Nurse Participants | n=8-10 nurses |
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| Phase 1: Patient Participants | n=8-10 patients |
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| Phase 2: Nurse Participants | n=8-10 nurses |
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| Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm | n=35 |
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| Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm | n=35 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meaning-Centered Psychotherapy/MCP-PC Training | Behavioral | Two-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Participant Inclusion Criteria:
Nurses (all phases):
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)
English fluency necessary for participation in the study:
Participant Exclusion Criteria:
Nurses (all phases):
Patients (all phases):
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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
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Saracina, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visiting Nurse Service of NY | New York | New York | 10021 | United States | ||
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41045824 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2024 | Apr 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Meaning-Centered Psychotherapy/MCP-PC | Behavioral | 3 sessions, completed over the course of 3-6 weeks in the participant's home |
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| Treatment As Usual/TAU | Behavioral | Research team will provide:
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| New York |
| New York |
| 10065 |
| United States |