Caregiver BurdenNCT06307535
A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer
A study testing Meaning-Centered Psychotherapy for Caregivers and Supportive Psychotherapy for Caregivers in people with Caregiver Burden and Caregiver Burnout, run by Icahn School of Medicine at Mount Sinai at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Caregiver Burnout, Caregiver Stress Syndrome
- What is being tested?
- Meaning-Centered Psychotherapy for Caregivers and Supportive Psychotherapy for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 13 Mar 2024to 1 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
- Recruiting
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
- Recruiting
University of Miami (Data Collection AND Data Analysis)
Miami, Florida, 33136
Wendy Lichtenthal, PhD, 305-243-8983
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Talia Zaider, PhD, 646-888-0162, zaidert@mskcc.org
About this study
Official title: Meaning-Centered Psychotherapy to Meet Palliative Care Needs of Cancer Caregivers
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.
- Being tested
- Meaning-Centered Psychotherapy for Caregivers, Supportive Psychotherapy for Caregivers
- Keywords
- Caregiver, Caregiver Stress Syndrome, Caregiver Burden, Caregiver Burnout, Meaning-Centered Psychotherapy, 23-376
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Psychotherapy for CaregiversBehavioural
Also called MCP-C
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 CaregiversBehavioural
Also called SP-C
Standard of care supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Meaning-Centered Psychotherapy for Caregivers | Experimental | Meaning-Centered Psychotherapy for Caregivers/MCP-C Receives: Behavioral: Meaning-Centered Psychotherapy for Caregivers |
| Supportive Psychotherapy for Caregivers | Active comparator | Supportive Psychotherapy for Caregivers/SP-C standard of care Receives: Behavioral: Supportive Psychotherapy for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Life Attitude Profile-Revised (LAP-R)
Life Attitude Profile-Revised (LAP-R) - used to measure sense of meaning in life.
The LAP-R is a 48-item instrument. Each item is rated on a 7-point Likert scale ranging from "strongly agree" to "strongly disagree." Full scale ranges from 30 to 210 with a higher score indicating a greater sense of meaning in life and a more positive attitude towards life.
Measured: Up to 1 year
FACIT Spiritual Well-Being Scale (SWBS)
The Spiritual Well-Being Scale (SWBS) - used to measure spiritual well-being.
The SWBS is a 12-item instrument. Each item is scored from 1 to 5. Negatively worded items are reverse scored. The measure generates two sub-scales: Faith/Spirituality (0-16) and Meaning/Peace (0-32). Full scale ranges from 0 to 48. Higher scores indicate a greater sense of spiritual well-being.
Measured: Up to 1 year
Secondary outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) - measures anxiety and depression.
14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating poorer health outcome.
Measured: Up to 1 year
Benefit Finding Scale (BFS)
Benefit Finding Scale (BFS) - measures benefit finding.
The BFS is a 17-item instrument. Each item is scored from 1-5 (not at all, a little bit, somewhat, quite a bit, or very much). Full scale ranges from 17 to 85, with higher scores indicating greater benefit finding.
Measured: Up to 1 year
Caregiver Reaction Assessment (CRA)
Caregiver Reaction Assessment (CRA) - measures caregiver burden.
The CRA is a 24-item instrument. Full scale ranges from 24 to 120, with higher scores indicating greater caregiving burden
Measured: Up to 1 year
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Duke-UNC Functional Social Support Questionnaire (FSSQ) - measures social support.
The FSSQ is an 8-item instrument. Each item is scored on a scale of 5-1 where 5=as much as I would like; 4=almost as much as I would like; 3=some, but would like more; 2=less than i would like, and 1=much less than I would like. Full scale ranges from 0 to 44 with higher scores indicating a higher degree of satisfaction related to social support.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start13 Mar 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of Miami Sylvester Comprehensive Cancer Center
- Responsible party
- Principal investigator, Allison Applebaum, Icahn School of Medicine at Mount Sinai
- Investigators
- Allison Applebaum, PhD, FAPOS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307535
- Sponsor's protocol ID
- STUDY-24-01356
- Status last verified
- May 2026
- First submitted
- 29 Feb 2024
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for deidentified individual participant data can be made from the date of publication until six years post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: MSIPinfo@mssm.edu
Publications
Applebaum AJ, Walsh LE, Zaider T, Baser RE, Loschiavo MJ, Breitbart WS, Lichtenthal WG. Meaning-Centered Psychotherapy for Cancer Caregivers: Study protocol of a randomized controlled trial. Trials. 2026 Mar 21;27(1):336. doi: 10.1186/s13063-026-09621-7.
PubMed 41864988Applebaum AJJ, Walsh LE, Zaider T, Baser RE, Loschiavo MJ, Breitbart WS, Lichtenthal WG. Meaning-Centered Psychotherapy for Cancer Caregivers Study protocol of a randomized controlled trial. Res Sq [Preprint]. 2026 Feb 4:rs.3.rs-7963562. doi: 10.21203/rs.3.rs-7963562/v1.
PubMed 41674824