Who is eligible for clinical trial NCT06307535?

Participants must meet protocol criteria for Caregiver Burden. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06307535 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-21

A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer (NCT06307535)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Icahn School of Medicine at Mount Sinai

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (3 items).

Location: University of Miami (Data Collection AND Data Analysis) — Miami, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗