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

NCT ID: NCT06307535

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2029-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Caregiver Burden Caregiver Burnout Caregiver Stress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Meaning-Centered Psychotherapy for Caregivers

Meaning-Centered Psychotherapy for Caregivers/MCP-C

Group Type EXPERIMENTAL

Meaning-Centered Psychotherapy for Caregivers

Intervention Type BEHAVIORAL

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

Supportive Psychotherapy for Caregivers/SP-C standard of care

Group Type ACTIVE_COMPARATOR

Supportive Psychotherapy for Caregivers

Intervention Type BEHAVIORAL

Standard of care supportive psychotherapy

Interventions

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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.

Intervention Type BEHAVIORAL

Supportive Psychotherapy for Caregivers

Standard of care supportive psychotherapy

Intervention Type BEHAVIORAL

Other Intervention Names

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MCP-C SP-C

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

University of Miami Sylvester Comprehensive Cancer Center

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Allison Applebaum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Applebaum, PhD, FAPOS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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University of Miami (Data Collection AND Data Analysis)

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Allison Applebaum, PhD, FAPOS

Role: CONTACT

212-241-8561

Morgan Loschiavo, MPH

Role: CONTACT

646-888-0225

Facility Contacts

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Wendy Lichtenthal, PhD

Role: primary

305-243-8983

Talia Zaider, PhD

Role: primary

646-888-0162

Talia Zaider, PhD

Role: primary

646-888-0162

Talia Zaider, PhD

Role: primary

646-888-0162

Talia Zaider, PhD

Role: primary

646-888-0162

Talia Zaider, PhD

Role: primary

646-888-0162

Talia Zaider, PhD

Role: primary

646-888-0162

Talia Zaider, PhD

Role: primary

646-888-0162

Other Identifiers

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STUDY-24-01356

Identifier Type: -

Identifier Source: org_study_id

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