Nurse-Patient RelationsNCT05495737
Meaning-Centered Psychotherapy at Home
An observational study of Nurse-Patient Relations and Psychology, Social, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse-Patient Relations, Psychology, Social
- What is being tested?
- Meaning-Centered Psychotherapy/MCP-PC Training, Meaning-Centered Psychotherapy/MCP-PC and Treatment As Usual/TAU
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2022to 8 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
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:
- 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)
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Visiting Nurse Service of NY
New York, New York, 10021
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Nurse-Patient Relations, Psychology, Social
- Being tested
- Meaning-Centered Psychotherapy/MCP-PC Training, Meaning-Centered Psychotherapy/MCP-PC, Treatment As Usual/TAU
- Keywords
- Meaning Centered Psychotherapy, Meaning Centered Psychotherapy for Palliative Patients, 22-019, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Psychotherapy/MCP-PC TrainingBehavioural
Two-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment
Meaning-Centered Psychotherapy/MCP-PCBehavioural
3 sessions, completed over the course of 3-6 weeks in the participant's home
Treatment As Usual/TAUBehavioural
Research team will provide:
- feedback about level of distress at time of screening
- local referral for psychological care
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Nurse Participants | n=8-10 nurses Receives: Behavioral: Meaning-Centered Psychotherapy/MCP-PC Training | |
| Phase 1: Patient Participants | n=8-10 patients Receives: Behavioral: Meaning-Centered Psychotherapy/MCP-PC | |
| Phase 2: Nurse Participants | n=8-10 nurses Receives: Behavioral: Meaning-Centered Psychotherapy/MCP-PC Training | |
| Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm | n=35 Receives: Behavioral: Meaning-Centered Psychotherapy/MCP-PC | |
| Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm | n=35 Receives: Behavioral: Treatment As Usual/TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start8 Aug 2022
- Primary completion8 Aug 2027 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Saracina, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495737
- Sponsor's protocol ID
- 22-019
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41045824
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Control Trial of Nurse-Delivered Brief Meaning Centered Psychotherapy for Homebound Palliative Care Patients
- ClinicalTrials.gov ID
- NCT05495737
- Acronym / sponsor ID
- 22-019
- Conditions
- Nurse-Patient Relations, Psychology, Social
- Keywords
- Meaning Centered Psychotherapy, Meaning Centered Psychotherapy for Palliative Patients, 22-019, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 8 Aug 2027 (estimated)
- Study completion
- 8 Aug 2027 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Nurse Participants | – | Behavioral: Meaning-Centered Psychotherapy/MCP-PC Trainingn=8-10 nurses |
| Phase 1: Patient Participants | – | Behavioral: Meaning-Centered Psychotherapy/MCP-PCn=8-10 patients |
| Phase 2: Nurse Participants | – | Behavioral: Meaning-Centered Psychotherapy/MCP-PC Trainingn=8-10 nurses |
| Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm | – | Behavioral: Meaning-Centered Psychotherapy/MCP-PCn=35 |
| Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm | – | Behavioral: Treatment As Usual/TAUn=35 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meaning-Centered Psychotherapy/MCP-PC TrainingTwo-Day MCP-PC Training for Nurses (including mock patient/simulation with actor) with a Pre- and Post-Training Assessment | Behavioural | Phase 1: Nurse Participants, Phase 2: Nurse Participants |
| Meaning-Centered Psychotherapy/MCP-PC3 sessions, completed over the course of 3-6 weeks in the participant's home | Behavioural | Phase 1: Patient Participants, Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm |
| Treatment As Usual/TAUResearch team will provide: 1. feedback about level of distress at time of screening 2. local referral for psychological care | Behavioural | Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 41045824Saracino 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Saracina, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse-Patient Relations and Psychology, Social, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPI Competency Ratings (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.