Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study

Обзор

The purpose of this study is to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.

Подробное описание

This research study is a feasibility pilot study and to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.

The research study procedures include screening for eligibility including evaluations of fitness and physical health, surveys, and study entry visits.

Participation in the study is expected to be about 24 weeks.

It is expected that about 20 people will take part in this research study

Вмешательства

• Поведенческое PERCC
  Personalized at-home exercise program, including aerobic and resistance exercise. Supervised by trained exercise professional via ZOOM (HIPPA complaint video conferencing platform). Study equipment of Fitbit and resistance bands will be provided to participants.

Первичные конечные точки

• Attendance of Exercise Sessions (Feasibility) [Срок оценки: From first exercise session to final exercise session (up to 24 weeks)]

Критерии участия

Критерии включения

• Age ≥18 years at time of diagnosis; due to the rarity of the disease in those <18 years, this age bracket will not be included.
• Histologically diagnosed with stage II or III non-small cell lung cancer (NSCLC) and has not started lung cancer treatment.
• Patient's treatment plan is to receive neoadjuvant therapy (defined as chemotherapy, chemotherapy and immunotherapy, or chemotherapy and radiation therapy) followed by surgical treatment. Patients will be enrolled at least three weeks prior to receiving their first neoadjuvant treatment.
• Ability to follow directions and complete questionnaires in English and/or Spanish.
• Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.
• Willing to travel to DFCI for necessary data collection.

Критерии исключения

• Patients who are morbidly obese (BMI>40 kg/m2) or Anorexic (BMI<17 kg/m2).
• Unstable comorbidities that contraindicate participation in exercise program compliance. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. Study staff will identify untreated or unmanaged conditions when screening and treating MDs must provide clearance prior to patient enrollment.
• Patients with alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer).
• Patients scheduled to receive single modality cancer treatment (unimodal therapy), scheduled surgery within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started.
• Patients who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
• Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

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 · 1 центр

• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT07412041 · 25-607

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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