A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer

Meaning-Centered Psychotherapy to Meet Palliative Care Needs of Cancer Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Burden; Caregiver Stress Syndrome; Caregiver Burnout
• Intervention / Treatment: Behavioral: Meaning-Centered Psychotherapy for Caregivers; Behavioral: Supportive Psychotherapy for Caregivers

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Applebaum, PhD, FAPOS; Phone Number: 212-241-8561; Email: allison.applebaum@mssm.edu
• Study Contact Backup: Name: Morgan Loschiavo, MPH; Phone Number: 646-888-0225; Email: LoschiaM@mskcc.org

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami (Data Collection AND Data Analysis)
      • Contact: Wendy Lichtenthal, PhD; Phone Number: 305-243-8983
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Consent only)
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited protocol activites)
      • Contact: Talia Zaider, PhD; Phone Number: 646-888-0162; Email: zaidert@mskcc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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, Connecticut, or Florida, or have the ability to complete sessions while complying with current telehealth regulations.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meaning-Centered Psychotherapy for Caregivers; Meaning-Centered Psychotherapy for Caregivers/MCP-C	Behavioral: Meaning-Centered Psychotherapy for Caregivers; 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.; Other Names: MCP-C
Active Comparator: Supportive Psychotherapy for Caregivers; Supportive Psychotherapy for Caregivers/SP-C standard of care	Behavioral: Supportive Psychotherapy for Caregivers; Standard of care supportive psychotherapy; Other Names: SP-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) - measures anxiety and depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating poorer health outcome.	Up to 1 year
Benefit Finding Scale (BFS)	Benefit Finding Scale (BFS) - measures benefit finding. The BFS is a 17-item instrument. Each item is scored from 1-5 (not at all, a little bit, somewhat, quite a bit, or very much). Full scale ranges from 17 to 85, with higher scores indicating greater benefit finding.	Up to 1 year
Caregiver Reaction Assessment (CRA)	Caregiver Reaction Assessment (CRA) - measures caregiver burden. The CRA is a 24-item instrument. Full scale ranges from 24 to 120, with higher scores indicating greater caregiving burden	Up to 1 year
Duke-UNC Functional Social Support Questionnaire (FSSQ)	Duke-UNC Functional Social Support Questionnaire (FSSQ) - measures social support. The FSSQ is an 8-item instrument. Each item is scored on a scale of 5-1 where 5=as much as I would like; 4=almost as much as I would like; 3=some, but would like more; 2=less than i would like, and 1=much less than I would like. Full scale ranges from 0 to 44 with higher scores indicating a higher degree of satisfaction related to social support.	Up to 1 year

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Memorial Sloan Kettering Cancer Center; University of Miami Sylvester Comprehensive Cancer Center
• Investigators: Principal Investigator: Allison Applebaum, PhD, FAPOS, ICAHN School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Applebaum AJ, Walsh LE, Zaider T, Baser RE, Loschiavo MJ, Breitbart WS, Lichtenthal WG. Meaning-Centered Psychotherapy for Cancer Caregivers: Study protocol of a randomized controlled trial. Trials. 2026 Mar 21;27(1):336. doi: 10.1186/s13063-026-09621-7.
• Applebaum AJJ, Walsh LE, Zaider T, Baser RE, Loschiavo MJ, Breitbart WS, Lichtenthal WG. Meaning-Centered Psychotherapy for Cancer Caregivers Study protocol of a randomized controlled trial. Res Sq [Preprint]. 2026 Feb 4:rs.3.rs-7963562. doi: 10.21203/rs.3.rs-7963562/v1.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Caregiver Burden; Caregiver; Caregiver Burnout; Meaning-Centered Psychotherapy; Caregiver Stress Syndrome; 23-376
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Caregiver Burden; Health Care Facilities Workforce and Services; Health Personnel; Caregivers
• Other Study ID Numbers: STUDY-24-01356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Until six years post publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No