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Идёт набор NCT06782581

CARE Study: Cancer, Asian Americans, and Relationship Enrichment

Без фазы С лечением Neoplasm

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: Contribution to Caregivers Well-Being, Control.
Кому может быть актуально
Состояния в реестре: Neoplasm. Базовые параметры: 21 лет — 80 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

Positive Activities for Asian American Cancer Patients and Caregivers

Обзор

The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.

Подробное описание

This study will introduce two new positive activities, household contribution and outside contribution, which have been specifically created for AA cancer patients and have not been previously investigated. These interventions have been developed with consideration of culture-related challenges, Hofstede's concept of collectivist cultures, and self-determination theory. This study will be the first randomized controlled trial to assess the impact of these new positive activities on Asian-American cancer patients.

Вмешательства

  • Поведенческое Contribution to Caregivers Well-Being
    Contribute to caregiver's well-being via household tasks.
  • Поведенческое Control
    factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet

Первичные конечные точки

  • Affect-Adjective Scale (modified) (AAS) [Срок оценки: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)]
  • Patient-Reported Outcomes Measurement Information System Global Health (PROMIS G10) [Срок оценки: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)]
Вторичные конечные точки (2)
  • Balanced Measure of Psychological Needs (BMPN) [Срок оценки: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)]
  • Self-Perceived Burden Scale [Срок оценки: Baseline/pre-intervention, midpoint/during the intervention (2 weeks), immediately after the intervention (4 weeks), and follow-up 4 weeks after the intervention (8 weeks)]

Критерии участия

Inclusion Criteria for Patients:

  • self-identifies as Asian American or Asian
  • males or females ages 21-80 years
  • within 2 years of any cancer diagnosis or stage 4 cancer diagnosis
  • actively undergoing surgery or systemic therapy (e.g., chemotherapy, radiation, immunotherapy) or within the past 6 months,
  • able to identify a caregiver (e.g., spouse) who lives in the same household or see at least 3 times per week
  • able to read, write, and speak English (i.e., English proficient; EP) or Mandarin/simplified Chinese.

Exclusion Criteria for patients:

  • life expectancy less than 6 months in the opinion of the primary physician
  • inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
  • major thought disorder (e.g., schizophrenia or bipolar \[patient records or self-disclosure\]).

Inclusion Criteria for Caregivers:

  • identifies as Asian American or Asian,
  • patient considers them to be caregiver
  • English proficient or Mandarin Chinese proficient
  • access to computer/phone, internet, and web browser.

Exclusion Criteria for Caregivers:

  • unwilling or unable to participate in the study for any reason,
  • under the age of 18.

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
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Fox Chase Cancer Center - Philadelphia — Philadelphia

Идентификаторы

NCT: NCT06782581 · 24-1006 · 5R00CA267678-04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗