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

Caregiver Burden Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307535
• Other study ID #: 23-376
• Status: Recruiting
• Phase: Phase 3
• Start date: February 29, 2024
• Est. completion date: March 1, 2029

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Allison Applebaum, PhD
• Phone: 646-888-0034
• Email: applebaa[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2029
• Est. primary completion date: March 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burden
• Caregiver Burnout
• Caregiver Stress Syndrome

Intervention

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.
• Supportive Psychotherapy for Caregivers
Standard of care supportive psychotherapy

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	University of Miami (Data Collection AND Data Analysis)	Miami	Florida
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activites)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center