A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer
Meaning-Centered Psychotherapy to Meet Palliative Care Needs of Cancer Caregivers
1 other identifier
interventional
200
1 country
8
Brief Summary
Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires. After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires. Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
July 28, 2025
July 1, 2025
5 years
February 29, 2024
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with improved primary outcomes
Evaluate the efficacy of MCP-C versus SP-C in improving primary outcomes (i.e., sense of meaning in life, spiritual well-being) immediately post-treatment and explore maintenance in gains up to 1 year.
Up to 1 year
Life Attitude Profile-Revised (LAP-R)
Life Attitude Profile-Revised (LAP-R) - used to measure sense of meaning in life. The LAP-R is a 48-item instrument. Each item is rated on a 7-point Likert scale ranging from "strongly agree" to "strongly disagree." Full scale ranges from 30 to 210 with a higher score indicating a greater sense of meaning in life and a more positive attitude towards life.
Up to 1 year
FACIT Spiritual Well-Being Scale (SWBS)
The Spiritual Well-Being Scale (SWBS) - used to measure spiritual well-being. The SWBS is a 12-item instrument. Each item is scored from 1 to 5. Negatively worded items are reverse scored. The measure generates two sub-scales: Faith/Spirituality (0-16) and Meaning/Peace (0-32). Full scale ranges from 0 to 48. Higher scores indicate a greater sense of spiritual well-being.
Up to 1 year
Secondary Outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
Up to 1 year
Benefit Finding Scale (BFS)
Up to 1 year
Caregiver Reaction Assessment (CRA)
Up to 1 year
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Up to 1 year
Study Arms (2)
Meaning-Centered Psychotherapy for Caregivers
EXPERIMENTALMeaning-Centered Psychotherapy for Caregivers/MCP-C
Supportive Psychotherapy for Caregivers
ACTIVE COMPARATORSupportive Psychotherapy for Caregivers/SP-C standard of care
Interventions
MCP-C is a stakeholder-informed, innovative, manualized intervention designed to assist caregivers to connect to a sense of meaning and purpose in life, despite the challenges of caregiving.
Standard of care supportive psychotherapy
Eligibility Criteria
You may qualify if:
- Age 18 or over;
- As per self-report, a current caregiver to a patient with Stage III or IV solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative);
- Experiences distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and an indication that this distress is associated with caregiving;
- As per self-report, can read and understand English;
- As per self-report, residing in New York, New Jersey, or Florida, or have the ability to complete sessions while complying with current telehealth regulations.
You may not qualify if:
- Participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional;
- Engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of Miami (Data Collection AND Data Analysis)
Miami, Florida, 33136, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Applebaum, PhD, FAPOS
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 13, 2024
Study Start
March 13, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Until six years post publication
Requests for deidentified individual participant data can be made from the date of publication until six years 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: MSIPinfo@mssm.edu