Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06307535

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Caregiver Burnout Caregiver Stress Syndrome Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami (Data Collection AND Data Analysis), Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, Connecticut, 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.

Treatment and study plan

Meaning-Centered Psychotherapy for Caregivers

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.

Other names: MCP-C

Supportive Psychotherapy for Caregivers

Behavioral

Standard of care supportive psychotherapy

Other names: SP-C

Primary outcomes

  1. Number of participants with improved primary outcomes

    Time frame: Up to 1 year

    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.

  2. Life Attitude Profile-Revised (LAP-R)

    Time frame: Up to 1 year

    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.

  3. FACIT Spiritual Well-Being Scale (SWBS)

    Time frame: Up to 1 year

    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.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Up to 1 year

    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.

  2. Benefit Finding Scale (BFS)

    Time frame: Up to 1 year

    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.

  3. Caregiver Reaction Assessment (CRA)

    Time frame: Up to 1 year

    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

  4. Duke-UNC Functional Social Support Questionnaire (FSSQ)

    Time frame: Up to 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Applebaum, PhD, FAPOS

CONTACT

[email protected]

212-241-8561

Morgan Loschiavo, MPH

CONTACT

[email protected]

646-888-0225

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center
  • University of Miami Sylvester Comprehensive Cancer Center

Registry information

Official study title

Meaning-Centered Psychotherapy to Meet Palliative Care Needs of Cancer Caregivers

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 13, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.