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

NCT ID: NCT06307535

Condition: Caregiver Burden
Caregiver Burnout
Caregiver Stress Syndrome

Conditions: Official terms:
Burnout, Psychological
Caregiver Burden

Conditions: Keywords:
Caregiver
Caregiver Stress Syndrome
Caregiver Burden
Caregiver Burnout
Memorial Sloan Kettering Cancer Center
23-376

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Meaning-Centered Psychotherapy for Caregivers
Description: 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.
Arm group label: Meaning-Centered Psychotherapy for Caregivers

Other name: MCP-C

Intervention type: Behavioral
Intervention name: Supportive Psychotherapy for Caregivers
Description: Standard of care supportive psychotherapy
Arm group label: Supportive Psychotherapy for Caregivers

Other name: SP-C

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Miami (Data Collection AND Data Analysis)

Address:
City: Miami
Zip: 33136
Country: United States

Status: Not yet recruiting

Contact:
Last name: Wendy Lichtenthal, PhD

Phone: 305-243-8983

Facility:
Name: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Facility:
Name: Memorial Sloan Kettering Monmouth (Limited protocol activities)

Address:
City: Middletown
Zip: 07748
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Facility:
Name: Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Address:
City: Montvale
Zip: 07645
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Facility:
Name: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Address:
City: Commack
Zip: 11725
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Facility:
Name: Memorial Sloan Kettering Westchester (Consent only)

Address:
City: Harrison
Zip: 10604
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Facility:
Name: Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Address:
City: Rockville Centre
Zip: 11553
Country: United States

Status: Recruiting

Contact:
Last name: Talia Zaider, PhD

Phone: 646-888-0162
Email: zaidert@mskcc.org

Start date: February 29, 2024

Completion date: March 1, 2029

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06307535
http://www.mskcc.org

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