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Набор скоро начнётся NCT07742969

The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes

Без фазы С лечением Breast Cancer Caregiver Caregiver Anxiety Self Care

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: Dyadic Self Care Education.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Caregiver, Caregiver Anxiety, Self Care. 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
Список центров уточняется — проверьте первичный протокол.
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

The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes: Self-Care Behavior, Anxiety Level, and Caregiver Burden

Обзор

This randomized controlled trial aims to evaluate the effect of dyadic self-care education provided to breast cancer patient-caregiver dyads receiving outpatient chemotherapy on patient self-care behaviors, anxiety levels, and caregiver anxiety levels and caregiver burden. Participants will be randomly assigned to either a dyadic self-care education intervention or routine care. Outcomes will be assessed at baseline and follow-up using validated instruments.

Вмешательства

  • Поведенческое Dyadic Self Care Education
    A structured dyadic self-care education program for breast cancer patient-primary caregiver dyads receiving outpatient chemotherapy. One patient and one primary caregiver constitute one dyad. The intervention includes four weekly face-to-face education sessions focusing on the management of chemotherapy-related side effects, self-care maintenance, symptom monitoring, infection prevention, nutrition, fatigue, oral care, skin care, medication adherence, and caregiver support. Assessments will be c

Первичные конечные точки

  • Patient Self-Care Behavior [Срок оценки: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
  • Patient Anxiety Assessed by the Beck Anxiety Inventory [Срок оценки: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
  • Caregiver Anxiety Assessed by the Beck Anxiety Inventory [Срок оценки: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
  • Caregiver Burden Assessed by the Zarit Burden Interview [Срок оценки: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]

Критерии участия

Критерии включения

Patients:

  • Female patients aged 18 years or older.
  • Diagnosed with stage II or III breast cancer.
  • Aware of their breast cancer diagnosis.
  • Receiving outpatient chemotherapy after mastectomy.
  • Having received at least one cycle of an EC (epirubicin-cyclophosphamide) or AC (doxorubicin-cyclophosphamide) chemotherapy regimen.
  • Able to read and write Turkish.
  • Having a primary caregiver who is willing to participate in the study.
  • Living with the primary caregiver.
  • Conscious, able to communicate effectively, and able to provide informed consent.
  • No diagnosed psychiatric disorder.

Primary Caregivers:

  • Aged 18 years or older.
  • Able to read and write Turkish.
  • Living with the patient.
  • Being the patient's spouse, parent, child, friend, or another relative.
  • Assuming the main responsibility for the patient's care.
  • Willing and able to cooperate and provide informed consent.
  • No diagnosed psychiatric disorder.

Критерии исключения

Patients:

  • Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
  • Admission to an intensive care unit during the study.
  • Progression of the disease to stage IV breast cancer.
  • Death or loss to follow-up.

Primary Caregivers:

  • Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
  • Deterioration in health that prevents continued participation.
  • Transfer of the primary caregiving responsibility to another person.

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07742969 · AU-BC-DYAD-26 · SDK-2026-17003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗