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Идёт набор NCT07504835

GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer

Без фазы С лечением Prostate Carcinoma

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: Socially enhanced supervised group exercise, Exercise Intervention, Unsupervised independent exercise.
Кому может быть актуально
Состояния в реестре: Prostate Carcinoma. Базовые параметры: от 65 лет · Мужчины.
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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Обзор

This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. This trial compares a socially-enhanced supervised group exercise program to a supervised group exercise program with no social enhancement, and an unsupervised home-based program on cancer loneliness, social isolation, mental and physical health in older prostate cancer survivors. All study arms exercise for 6 months and outcomes are measured at baseline, 3 and 6 months. The primary outcome is cancer loneliness with secondary outcomes of mental and physical health.

Подробное описание

PRIMARY OBJECTIVE I. Determine the preliminary efficacy of socially-enhanced supervised group exercise on cancer loneliness and social isolation in older PCS.

SECONDARY OBJECTIVE:

I. Examine potential mediators of the effect of socially-enhanced supervised group exercise on cancer loneliness (social support for exercise, cancer-related negative social expectations and self-efficacy).

TERTIARY OBJECTIVE:

I. Determine the preliminary efficacy of socially-enhanced supervised group exercise on mental health (anxiety, depressive symptoms) and physical health (fatigue and physical function) in older PCS.

OUTLINE: PCS are randomized to 1 of 3 arms.

ARM I: PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months.

ARM II: PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months.

ARM III: PCS participate in independent exercise training following written manual and video over 60 minutes 3 times weekly over 6 months. Men have two individual training sessions with the trainer to learn the exercise program and then the trainer will check in monthly to adjust the program as necessary.

Вмешательства

  • Поведенческое Socially enhanced supervised group exercise
    Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session
  • Поведенческое Exercise Intervention
    Participate in a one hour online supervised group exercise session
  • Поведенческое Unsupervised independent exercise
    Participate a one hour exercise session at home by following a written manual and video

Первичные конечные точки

  • Cancer loneliness [Срок оценки: Baseline, 3- and 6-months]
Вторичные конечные точки (4)
  • General loneliness [Срок оценки: Baseline, 3- and 6-months]
  • Social isolation [Срок оценки: Baseline, 3- and 6-months]
  • Physical health [Срок оценки: Baseline, 3- and 6-months]
  • Mental health [Срок оценки: Baseline, 3- and 6-months]

Критерии участия

Критерии включения

  • Age 65 years of age or older.
  • Diagnosed with histologically confirmed prostate cancer.
  • Completed surgery, chemotherapy, radiation and/or systemic treatment (other than ADT) for cancer > 3 months ago.
  • Experiencing cancer loneliness.
  • Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed.
  • Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions.
  • Home internet sufficient for videoconferencing.

Критерии исключения

  • Participating in regular group exercise and/or structured resistance training with other cancer survivors (> 1 exercise partner or groups of 3 or more).
  • Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise.
  • Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent.
  • Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English.

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

США · 1 центр
  • OHSU Knight Cancer Institute — Portland

Идентификаторы

NCT: NCT07504835 · STUDY00029324 · NCI-2025-09477 · STUDY00029324

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗