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