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Идёт набор NCT07218250

A Study of a One-Time Counseling Session to Help Reduce Depression, Anxiety, and Distress in People With Breast Cancer

Без фазы С лечением Breast Cancer

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: Single Counseling Session, American Cancer Society booklet.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
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 →

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Официальное название

Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Breast Cancer Patients

Обзор

The purpose of this study is to see if a Single Counseling Session for Cancer can help reduce psychosocial distress and improve quality of life in people with breast cancer who are waiting to receive ongoing counseling services (outpatient psychotherapy services). The Single Counseling Session for Cancer-which I will refer to as the "study counseling" during this call-is a one-session, 60-minute counseling program designed to reduce anxiety and depression symptoms in people with cancer who are waiting to receive outpatient psychotherapy services. The researchers will look at whether the study counseling is effective in participants and practical (feasible) for them to complete.

Вмешательства

  • Поведенческое Single Counseling Session
    The one-time counseling session will be a problem-solving focused program that will try to strengthen the belief in the ability to manage the challenges of the cancer diagnosis and treatment
  • Другое American Cancer Society booklet
    called "After Diagnosis: A Guide for Patients and Families" for review. Again, this booklet includes information about cancer, living with cancer, making treatment decisions, talking to others about cancer, cancer treatment, and questions for the cancer care team. It will be given in person or by email.

Первичные конечные точки

  • Acceptability (SSC-C participants) [Срок оценки: up to 3 months]
  • Acceptability (PPSB participants) [Срок оценки: up to 3 months]
Вторичные конечные точки (1)
  • Psychosocial distress [Срок оценки: up to 3 months]

Критерии участия

Критерии включения

  • Patient must have pathologically confirmed breast cancer (per EMR).
  • Patient with localized or advanced cancer (per EMR).
  • Patient is on a waitlist of at least 2 weeks or more for MSK Counseling Center intake and will not complete a New Visit with a clinical psychologist prior to intervention (these patients will be replaced) (per EMR, patient's care team, or self-report)
  • Has not had and is not scheduled to have an appointment with an MSK psychiatrist or MSK Counseling Center advanced practice provider (per EMR, patient's care team, or self-report)
  • Female (per EMR)
  • Age ≥ 18 (per EMR)
  • English fluency - Per self-report: How well do you speak English?
  • Agrees to be audio-recorded (per self-report) NOTE: Participants who report Very well are considered fluent.
  • Lives in New York, New Jersey, Connecticut, or Florida (per self-report).
  • Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require urgent or extended individual treatment) (per EMR, patient's care team, or study team).
  • Has no presence of cognitive impairment disorder (i.e., delirium, dementia, or traumatic brain injury) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, study team, or per self-report of BOMC cognitive test).
  • Has no current active or passive suicidal ideation ((per EMR, patient's care team, study team, per item 9 of the PHQ-9, or the CSSRS).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
  • Memorial Sloan Kettering Bergen (Consent Only) — Montvale
  • Memorial Sloan Kettering Suffolk- Commack (Consent Only) — Commack
  • Memorial Sloan Kettering Westchester (Consent Only) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Consent Only) — Uniondale

Идентификаторы

NCT: NCT07218250 · 25-281

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗