An Individualized Online Home-Based Exercise Program for Improving Symptoms in Gynecologic Cancer Survivors
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: Exercise Intervention, Functional Assessment, Medical Device Usage and Evaluation, Questionnaire Administration.
- Кому может быть актуально
- Состояния в реестре: Malignant Female Reproductive System Neoplasm. 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
- 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
Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study
Обзор
This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. These symptoms can significantly reduce the quality of life (QoL) and survival rate in this cancer population. Thus, promoting physical activity among cancer survivors may help mitigate these severe symptoms. Using online platforms such as Zoom can help participants access an individualized exercise program that meets their specific needs to engage in physical activity and decrease their symptom burden. Home-based exercise, by providing self-chosen time and location and low costs, can address some barriers to physical activity for cancer survivors. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in gynecologic cancer survivors.
Подробное описание
PRIMARY OBJECTIVES:
I. To examine the feasibility and acceptability of an individualized home-based exercise program in gynecologic cancer survivors.
II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors.
OUTLINE:
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the rate of perceived exertion (RPE) scale and receive social support over 30 minutes twice a week (BIW) for 12 weeks.
Вмешательства
- Другое Exercise Intervention
Participate in an individualized online home-based exercise intervention - Другое Functional Assessment
Complete functional capacity assessment - Другое Medical Device Usage and Evaluation
Wear an activity tracker - Другое Questionnaire Administration
Ancillary studies - Другое Supportive Care
Receive social support
Первичные конечные точки
- Attrition Rates (Feasibility) [Срок оценки: At 12 weeks]
- Adherence Rates (Feasibility) [Срок оценки: At 12 weeks]
- Intervention Acceptability [Срок оценки: Up to 12 weeks]
- Gut Microbiome [Срок оценки: From baseline to 12 weeks]
- Psychoneurological Symptoms [Срок оценки: From baseline to 12 weeks]
Вторичные конечные точки (3)
- Quality of Life Assessment [Срок оценки: Up to 12 weeks]
- Rapid Eating Assessment for Participants [Срок оценки: Up to 12 weeks]
- Stress [Срок оценки: Up to 12 weeks]
Критерии участия
Критерии включения
- Women aged ≥ 18 years old
- Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical)
- Completed cancer treatment (chemotherapy or chemoradiation)
- Able to read and speak English
- Do not meet recommended exercise levels as defined by The American College of Sports Medicine
Критерии исключения
- History of metastatic or other primary cancer
- Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression)
- Certain chronic diseases (e.g., muscular-skeletal diseases that limit mobility, autoimmune diseases, uncontrolled diabetes, hypertension, renal disease (creatinine > 2.5 mg/dL)
- Unable to read/speak English
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 4 центра
- Grady Health System — Atlanta
- Emory University Hospital Midtown — Atlanta
- Emory University Hospital/Winship Cancer Institute — Atlanta
- Emory Decatur Hospital — Decatur
Идентификаторы
NCT: NCT06709534 · STUDY00007783 · P30CA138292 · NCI-2024-08387 · EU6320-24