Meaning Centered Psychotherapy for Palliative Care Patients (MCP-PC) (MCP-PC)

August 24, 2021 updated by: Fordham University

Development of Meaning Centered Psychotherapy for Palliative Care Patients

This randomized, controlled trial evaluates the effectiveness of an adaptation of a well-established brief, structured existential psychotherapy (Meaning Centered Psychotherapy) specifically tailored to the needs of palliative care patients (MCP-PC). Terminally ill patients with cancer who have been hospitalized in a palliative care hospital will be randomly assigned to either MCP-PC or enhanced usual care. Patients will complete a very short battery of self-report measures before the 3-session intervention, and again 2 and 4 weeks later to determine whether treatment has bolstered spiritual and psychological well-being and improved quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

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

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Terminal illness with life expectancy of less than 6 months; hospitalized at a palliative care facility in Bronx NY, English speaking

Exclusion Criteria:

  • Cognitive impairment or severe psychiatric symptoms that preclude informed consent or participation in treatment.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Enhanced Usual Care
facilitate any clinical interventions
Behavioral: Meaning Centered Psychotherapy
Manualized, 3-session existential psychotherapy (30-45 minutes/session) with an optional 4th "booster" session. Content focuses on enhancing patients sense of meaning and purpose in life.
Experimental: Meaning Centered Psychotherapy
raise patients' sense of meaning/purpose
Behavioral: Meaning Centered Psychotherapy
Manualized, 3-session existential psychotherapy (30-45 minutes/session) with an optional 4th "booster" session. Content focuses on enhancing patients sense of meaning and purpose in life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spiritual Well Being
Time Frame: Through study completion (approx 6 weeks)
Overall spiritual well-being as measured through the self-report FACIT Spiritual Well Being scale
Through study completion (approx 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopelessness
Time Frame: Through study completion (approx 6 weeks)
Self-report rating scale, the Hopelessness Assessment in Illness scale
Through study completion (approx 6 weeks)
Acceptance of Death
Time Frame: Through study completion (approx 6 weeks)
Subscale derived from the Life Attitude Profile, a self-report measure of meaning and purpose
Through study completion (approx 6 weeks)
Health related Quality of life
Time Frame: Through study completion (approx 6 weeks)
Single item rating of overall quality of life derived from the McGill Quality of Life Questionnaire
Through study completion (approx 6 weeks)
Desire for hastened death
Time Frame: Through study completion (approx 6 weeks)
Abbreviated version of the Schedule of Attitudes towards Hastened Death, a measure of desire for hastened death
Through study completion (approx 6 weeks)

Collaborators and Investigators

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

Sponsor

Fordham University

Collaborators

Calvary Hospital, Bronx, NY

Investigators

  • Principal Investigator: Barry Rosenfeld, PhD, Fordham University

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.

General Publications

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 (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R21 NR017728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be made available upon request following completion of the study.

IPD Sharing Time Frame

One year after completion of data collection.

IPD Sharing Access Criteria

Affiliation with medical or university-based research institute

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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.

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