Testing a Brief Motivational Intervention to Increase Physical Activity for Cancer Survivors

Официальное название

Effectiveness and Implementation of a Brief Motivational Intervention to Increase Physical Activity for World Trade Center Health Program Cancer Survivors

Обзор

The goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program.

Подробное описание

The World Trade Center Health Program (WTCHP) tracks the ongoing health and well-being of over 91,000 first responders and people who lived and worked near the World Trade Center. Research has established that WTCHP members are at higher risk for a constellation of health conditions, including cancer. Cancer survivors, the focus of this study, are at risk for physical and functional impairment. As WTCHP members with cancer age, developing pragmatic interventions to mitigate physical decline is an important next step in a coordinated program of care and research in this vulnerable population. Physical activity (PA) interventions are strong candidates for investigation, given that physical inactivity in WTCHP members has been correlated with respiratory illness, poor sleep, and PTSD. PA has many health benefits, yet interventions to support PA are not routinely incorporated into clinical practice. Evidence-based guidelines recommend PA counseling in clinical care and health professionals believe they should be doing this. However, a gap remains in implementing PA interventions at the point of care. This study will test an evidence-based motivational intervention to initiate and maintain PA among WTCHP particpatants with cancer.

Вмешательства

• Поведенческое Brief Motivational Intervention
  The study includes a 3-component motivational intervention based on the Theory of Planned Behavior. The components include motivational interviewing (MI); mobile health monitoring; and action planning. MI is used to build a positive attitude towards physical activity (PA). Mobile health monitoring will be conducted with a Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. The research t

Первичные конечные точки

• Change in Moderate to Vigorous Physical Activity [Срок оценки: Baseline to end of study (6 months)]

Вторичные конечные точки (5)

• Quality of Life (SF-20) [Срок оценки: Baseline to end of study (6 months)]
• Sleep (PROMIS Sleep SF) [Срок оценки: Baseline to end of study (6 months)]
• Fatigue (PROMIS Fatigue SF) [Срок оценки: Baseline to end of study (6 months)]
• Physical Functioning (Short Physical Performance Battery) [Срок оценки: Baseline to end of study (6 months)]
• Post traumatic stress disorder (PCL-5) [Срок оценки: Baseline to end of study (6 months)]

Критерии участия

Критерии включения

• Participation in the World Trade Center Health Program
• History of cancer, completed treatment
• Ability to be physically active (at minimum be able to walk slowly)

Критерии исключения

• Participants receiving active cancer treatment (excluding hormonal therapy);
• Late-stage cancer (metastatic);
• Inability to follow the scheduled visits;
• Women who are pregnant
• Patients who would not be safe exercising without medical supervision (ECOG score of 3, significant comorbidities, unable to even walk slowly)
• Inability to speak and read English.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stony Brook University — Stony Brook

Идентификаторы

NCT: NCT07215091 · IRB2024-00344 · 5R21OH012630-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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