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Идёт набор NCT07030686

Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors

— Наблюдательное Survivorship Recurrent Recurrence Cancer

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.
Кому может быть актуально
Состояния в реестре: Survivorship, Recurrent, Recurrence, Cancer. 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

This protocol is a retrospective study using observational data to conduct a target trial emulation to examine the association of exercise on cancer specific endpoints and other clinical outcomes in cancer survivors.

Вмешательства

  • Поведенческое Exercise
    Exercise following completion of active treatment for the primary index cancer

Первичные конечные точки

  • Distant disease-free survival (DDFS) [Срок оценки: 5 years]

Критерии участия

Критерии включения

Target trial (ideal RCT)

  • Adult (≥18 years of age) patients with history of primary invasive cancer under surveillance at Memorial Sloan Kettering Cancer Center (MSK).
  • Completion of an exercise survey (baseline) as part of MSK Cancer Survivorship Program and completion of a historical survey in the MSK Cancer Survivorship Program 9-15 months (time th) prior reporting non-exercising status \[i.e., reporting <10 metabolic equivalent-hours per week (MET-h/week)\]. Patients completing an additional exercise survey between th and baseline are excluded.
  • No evidence of recurrent or metastatic disease in the 15 months prior to the baseline exercise assessment
  • Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of the historical exercise survey in a MSK Cancer Survivorship Program. Adjuvant hormonal therapy is permitted at any time.
  • Undergoing surveillance in the Cancer Survivorship Program at MSK

Emulation using observational data

  • Adult (≥18 years of age) cancer survivors under surveillance at Memorial Sloan Kettering Cancer Center (MSK) between 2011 and 2023.
  • Assessment of self-reported exercise status via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake (baseline assessment).
  • Non-exercising (i.e., reporting <5 MET-h/week) via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake 9-15 months prior to the baseline exercise assessment (historical exercise survey).
  • Documented history of the following absolute contraindications to moderate-intensity exercise at any time prior to the baseline exercise assessment, assessed using the Elixhauser ICD codes: Congestive heart failure, valvular disease, chronic pulmonary disease, or renal failure.
  • No evidence of recurrent or metastatic disease via radiological or pathological in EMR in the 15 months prior to the baseline exercise assessment.
  • Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of historical exercise survey (i.e., at least 3 months prior to t-1) as part of MSK Cancer Survivorship Program standard intake. Adjuvant endocrine therapy is permitted.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 4 центра
  • City of Hope Cancer Center (Data Analysis Only) — Duarte
  • University of California, Los Angeles (Data or Specimen Analysis Only) — Los Angeles
  • Weill Cornell Medical College (Data or Specimen Analysis Only) — New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Идентификаторы

NCT: NCT07030686 · 20-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗