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

NCT03612050 | Unknown DMC

• 1 other identifier: R21 NR017728
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Palliative Care

Keywords

Palliative care; Despair; Spiritual well-being

Outcome Measures

Primary Outcomes (1)

• Spiritual Well Being

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

  Through study completion (approx 6 weeks)

Secondary Outcomes (4)

• Hopelessness

  Through study completion (approx 6 weeks)

• Acceptance of Death

  Through study completion (approx 6 weeks)

• Health related Quality of life

  Through study completion (approx 6 weeks)

• Desire for hastened death

  Through study completion (approx 6 weeks)

Study Arms (2)

Enhanced Usual Care

PLACEBO COMPARATOR

facilitate any clinical interventions

Behavioral: Meaning Centered Psychotherapy

Meaning Centered Psychotherapy

EXPERIMENTAL

raise patients' sense of meaning/purpose

Behavioral: Meaning Centered Psychotherapy

Interventions

Meaning Centered Psychotherapy BEHAVIORAL

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.

Enhanced Usual Care; Meaning Centered Psychotherapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fordham University: lead
• Calvary Hospital, Bronx, NY: collaborator

Related Publications (1)

• 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.

  PMID: 27435603 BACKGROUND

Study Officials

• Barry Rosenfeld, PhD

  Fordham University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barry D Rosenfeld, PhD

CONTACT

718-817-3794; rosenfeld@fordham.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: August 2, 2018
• Study Start: January 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after completion of data collection.
• Access Criteria: Affiliation with medical or university-based research institute