A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT06307535
- Status
- Recruiting
Conditions
- Caregiver Burden
- Caregiver Burnout
- Caregiver Stress Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Meaning-Centered Psychotherapy for Caregivers — BEHAVIORALMCP-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 — BEHAVIORALStandard of care supportive psychotherapy
Study Details
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.
Key Dates
- Start date
- Mar 13, 2024
- Status verified
- May 2026
- Primary completion
- Mar 1, 2029
- Completion
- Mar 1, 2029
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Meaning-Centered Psychotherapy for CaregiversMeaning-Centered Psychotherapy for Caregivers/MCP-C
- Active Comparator: Supportive Psychotherapy for CaregiversSupportive Psychotherapy for Caregivers/SP-C standard of care
Primary Outcome Measure
Number of participants with improved primary outcomes [ Time Frame: Up to 1 year ]
Central Contacts
- Allison Applebaum, PhD, FAPOS212-241-8561
- Morgan Loschiavo, MPH646-888-0225
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami (Data Collection AND Data Analysis) | Miami | Florida | 33136 | Wendy Lichtenthal, PhD 305-243-8983 |
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | 07920 | |
| Memorial Sloan Kettering Monmouth (Limited protocol activities) | Middletown | New Jersey | 07748 | |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | Commack | New York | 11725 | |
| Memorial Sloan Kettering Westchester (Consent only) | Harrison | New York | 10604 | |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York | 11553 |
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