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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03612050
Other study ID # R21 NR017728
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information

Verified date August 2021
Source Fordham University
Contact Barry D Rosenfeld, PhD
Phone 718-817-3794
Email rosenfeld@fordham.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Fordham University Calvary Hospital, Bronx, NY

References & 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. — View Citation

Outcome

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