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Идёт набор NCT06565052

The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial

Без фазы С лечением Rectal Cancer Colorectal Cancer Rectal Cancer Stage II Rectal Cancer Stage III

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: Prehabilitation Program.
Кому может быть актуально
Состояния в реестре: Rectal Cancer, Colorectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III. Базовые параметры: от 18 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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Обзор

The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care

Подробное описание

This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery.

Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance.

The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires.

It is expected that about 40 participants will take part in this research study.

Вмешательства

  • Поведенческое Prehabilitation Program
    A hybrid-based, prehabilitation regimen comprised of nutritional optimization (multivitamin and protein supplement shake) and virtual, aerobic and resistance exercise sessions with clinical exercise physiologists. Virtual exercise sessions will be performed via a HIPAA-compliant videoconferencing platform or by phone call. Mini-exercise cycle ergometer, dumbbells, and resistance bands will be provided and delivered to participant. Heart rate monitors and wi-fi enable tablet will be provided if n

Первичные конечные точки

  • Enrollment Rate [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Adherence Rate to the Prehabilitation Program [Срок оценки: At post-intervention (approximately Week 4)]
  • Completion Rate of Physical Function Testing (Group A) [Срок оценки: At post-intervention (approximately Week 4)]
  • Completion Rate of Physical Function Testing (Group B) [Срок оценки: At post-intervention (approximately Week 4)]
  • Completion Rate of Questionnaire Assessments [Срок оценки: At baseline and the postoperative visit (approximately Week 9)]
  • Participant Fall Rate (Group A) [Срок оценки: At post-intervention (approximately Week 4)]
  • Participant Fall Rate (Group B) [Срок оценки: At post-intervention (approximately Week 4)]
  • Rate of Hospitalization (Group A) [Срок оценки: At post-intervention (approximately Week 4)]
  • Rate of Hospitalization (Group B) [Срок оценки: At post-intervention (approximately Week 4)]
  • Rate of Musculoskeletal Injury (Group A) [Срок оценки: At post-intervention (approximately Week 4)]
  • Rate of Musculoskeletal Injury (Group B) [Срок оценки: At post-intervention (approximately Week 4)]
  • Change in Resting Blood Pressure from Baseline to Post-Intervention [Срок оценки: From baseline to post-operative visit (approximately week 9)]
  • Change in Cardiorespiratory Fitness from Baseline to Post-Intervention [Срок оценки: From baseline to post-operative visit (approximately week 9)]

Критерии участия

Критерии включения

  • Age greater than or equal to 18 years at time of enrollment.
  • English-Speaking.
  • Diagnosis of clinical stage II-III rectal cancer.
  • Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
  • Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.

Критерии исключения

  • Distant metastatic disease known at the time of diagnosis.
  • Functional incapacity (i.e., incapable of performing exercise testing).
  • Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
  • Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
  • Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
  • Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.

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 · 2 центра
  • Dana-Farber Cancer Institute — Boston
  • Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06565052 · 24-384

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗