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Идёт набор NCT05721976

With Love, Grandma ("Con Cariño, Abuelita") Pilot Study

Без фазы С лечением Cancer, Breast Cancer, Uterus Cancer, Ovary Obesity

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: With Love, Grandma ("Con Cariño, Abuelita").
Кому может быть актуально
Состояния в реестре: Cancer, Breast, Cancer, Uterus, Cancer, Ovary, Obesity. Базовые параметры: от 21 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 →
Официальное название

Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families

Обзор

The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.

Вмешательства

  • Поведенческое With Love, Grandma ("Con Cariño, Abuelita")
    Cancer survivor-Daughter dyads will log in to a secured website to access intervention content over a period of 10-12 weeks. The intervention will be delivered primarily through smartphones and will include 8 modules with didactic content on healthy lifestyle behaviors for cancer prevention and control, family behavior change content for setting weekly goals and self-monitoring health behaviors, and family communication and positive parenting/grandparenting content, all of which were developed i

Первичные конечные точки

  • Percent of survivor-daughter dyads retained at post-intervention (feasibility) [Срок оценки: Up to 3 months]
  • Percent of modules completed by survivor-daughter dyads (acceptability) [Срок оценки: Up to 3 months]
Вторичные конечные точки (3)
  • Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ) [Срок оценки: Baseline, Up to 3 months]
  • Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire [Срок оценки: Baseline, Up to 3 months]
  • Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener [Срок оценки: Baseline, Up to 3 months]

Критерии участия

Cancer Survivor Inclusion Criteria:

  • Grandmother
  • Self-identifies as Hispanic
  • Diagnosis of breast cancer (stages I-III), endometrial or ovarian cancer (stages I-II)
  • Completed active treatment (i.e., surgery, chemotherapy, and/or radiation)
  • Body Mass Index (BMI) ≥ 25 (overweight range)
  • Engages in <150 minutes/week of moderate physical activity
  • English or Spanish speaking
  • Owns a mobile device with internet access (e.g., smartphone, tablet)
  • Lives in South Florida

Daughter of Cancer Survivor Inclusion Criteria:

  • Adult daughter of the identified cancer survivor (21 years of age or older)
  • Has at least 1 living child ages ≤16 years old
  • Body Mass Index (BMI) ≥ 25 (overweight range) OR engages in <150 minutes/week of moderate physical activity
  • English or Spanish speaking
  • Owns a mobile device with internet access (e.g., smartphone, tablet)
  • Lives in South Florida

Daughter of Cancer Survivor Exclusion Criteria:

  • Has been diagnosed with distant metastatic cancer
  • Has not completed active treatment (i.e., surgery, chemotherapy, and/or radiation)
  • Has uncontrolled schizophrenia or bipolar disorder
  • Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions,wheelchair bound).

Cancer Survivor Exclusion Criteria:

  • Has uncontrolled schizophrenia or bipolar disorder
  • Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions, wheelchair bound)

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
Лечение

Центры проведения

США · 1 центр
  • University of Miami — Miami

Идентификаторы

NCT: NCT05721976 · 20201421 · 2018-024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗