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

• Sponsor: Fordham University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03612050
• Collaborator: Calvary Hospital, Bronx, NY (Other)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Palliative Care	Behavioral: Meaning Centered Psychotherapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Development of Meaning Centered Psychotherapy for Palliative Care Patients
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Spiritual Well Being [Through study completion (approx 6 weeks)]

   Overall spiritual well-being as measured through the self-report FACIT Spiritual Well Being scale

Secondary Outcome Measures

1. Hopelessness [Through study completion (approx 6 weeks)]

   Self-report rating scale, the Hopelessness Assessment in Illness scale

2. Acceptance of Death [Through study completion (approx 6 weeks)]

   Subscale derived from the Life Attitude Profile, a self-report measure of meaning and purpose

3. Health related Quality of life [Through study completion (approx 6 weeks)]

   Single item rating of overall quality of life derived from the McGill Quality of Life Questionnaire

4. Desire for hastened death [Through study completion (approx 6 weeks)]

   Abbreviated version of the Schedule of Attitudes towards Hastened Death, a measure of desire for hastened death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fordham University
• Calvary Hospital, Bronx, NY

Investigators

• Principal Investigator: Barry Rosenfeld, PhD, Fordham University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Rosenfeld B, Saracino R, Tobias K, Masterson M, Pessin H, Applebaum A, Brescia R, Breitbart W. Adapting Meaning-Centered Psychotherapy for the palliative care setting: Results of a pilot study. Palliat Med. 2017 Feb;31(2):140-146. doi: 10.1177/0269216316651570. Epub 2016 Jul 21.

• Responsible Party: Fordham University
• ClinicalTrials.gov Identifier: NCT03612050
• Other Study ID Numbers: R21 NR017728
• First Posted: Aug 2, 2018
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fordham University: Palliative care; Despair; Spiritual well-being

Study Results

No Results Posted as of Aug 30, 2021