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Идёт набор NCT06307535

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

Без фазы С лечением Caregiver Burden Caregiver Burnout Caregiver Stress Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Meaning-Centered Psychotherapy for Caregivers, Supportive Psychotherapy for Caregivers.
Кому может быть актуально
Состояния в реестре: Caregiver Burden, Caregiver Burnout, Caregiver Stress Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое Meaning-Centered Psychotherapy for Caregivers
    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.
  • Поведенческое Supportive Psychotherapy for Caregivers
    Standard of care supportive psychotherapy

Первичные конечные точки

  • Number of participants with improved primary outcomes [Срок оценки: Up to 1 year]
  • Life Attitude Profile-Revised (LAP-R) [Срок оценки: Up to 1 year]
  • FACIT Spiritual Well-Being Scale (SWBS) [Срок оценки: Up to 1 year]
Вторичные конечные точки (4)
  • Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Up to 1 year]
  • Benefit Finding Scale (BFS) [Срок оценки: Up to 1 year]
  • Caregiver Reaction Assessment (CRA) [Срок оценки: Up to 1 year]
  • Duke-UNC Functional Social Support Questionnaire (FSSQ) [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 8 центров
  • University of Miami (Data Collection AND Data Analysis) — Miami
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack
  • Memorial Sloan Kettering Westchester (Consent only) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre

Публикации

  • 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. PMID 41864988
  • Applebaum 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. PMID 41674824

Идентификаторы

NCT: NCT06307535 · STUDY-24-01356

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗