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: Phase 3

Contacts and Locations

• Study Contact: Name: Allison Applebaum, PhD; Phone Number: 646-888-0034; Email: applebaa@mskcc.org
• Study Contact Backup: Name: William Breitbart, MD; Phone Number: 646-888-0020; Email: breitbaw@mskcc.org

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet 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: Allison Applebaum, PhD; Phone Number: 646-888-0034
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Allison Applebaum, PhD; Phone Number: 646-888-0034
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Allison Applebaum, PhD; Phone Number: 646-888-0034
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
      • Contact: Allison Applebaum, PhD; Phone Number: 646-888-0034
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Consent only)
      • Contact: Allison Applebaum, PhD; Phone Number: 646-888-0034
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Allison Applebaum, PhD; Phone Number: 646-888-0034
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
      • Contact: Allison Applebaum, PhD; Phone Number: 646-888-0034

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, 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: Other
• 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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Allison Applebaum, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 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): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Caregiver Burden; Caregiver; Memorial Sloan Kettering Cancer Center; Caregiver Burnout; Caregiver Stress Syndrome; 23-376
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological; Caregiver Burden
• Other Study ID Numbers: 23-376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months 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: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No