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Идёт набор NCT04452825

A New Psychotherapy Intervention for Older Cancer Patients

Без фазы С лечением 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: Cancer and Aging: Reflections for Elders (CARE) Intervention, Social Work and Supportive Counseling (SWSC) Intervention.
Кому может быть актуально
Состояния в реестре: Cancer. Базовые параметры: от 70 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 →

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Официальное название

Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer

Обзор

This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression and distress in older cancer patients. CARE is a 5-session intervention that takes place over the phone. This study will compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been shown to be a supportive and effective form of treatment for distress for patients with cancer. The researchers will look at which intervention is more effective in treating depression and distress in participants.

Вмешательства

  • Поведенческое Cancer and Aging: Reflections for Elders (CARE) Intervention
    For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
  • Поведенческое Social Work and Supportive Counseling (SWSC) Intervention
    The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the

Первичные конечные точки

  • Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 9 months]

Критерии участия

Критерии включения

  • As per self-report or medical record, ≥ 70 years of age
  • As per self-report or medical record, has a diagnosis of cancer
  • As per self-report or medical record, receiving active treatment (e.g., radiation, chemotherapy, hormone); OR received active treatment in the past 6 months (N/A for training case participants); OR are currently on active surveillance with follow-ups at least approximately every 6 months
  • Received a HADS-D score of ≥ 6 or HADS-A score of ≥ 6 or a score of ≥ 4 on the distress thermometer. (N/A for training case participants)
  • Received a Karnofsky Performance Rating Scale (KPRS) score of ≥ 60 (N/A for training case participants)
  • Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for training case participants)
  • Fluent in English, as per self-reported fluency of "well" or "very well"\*

Критерии исключения

  • As per self-report, currently taking antidepressant medication for < 3 months
  • As per self-report, currently receiving hospice care
  • In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
  • As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
  • Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:
  • How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
  • What is your preferred language for healthcare? (must respond English)

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 · 1 центр
  • Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT04452825 · 20-191

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗