Promoting Active Living Among People With Metastatic Breast Cancer

Официальное название

Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Metastatic Breast Cancer

Обзор

Individuals with metastatic breast cancer are living longer but often face persistent fatigue, functional decline, and psychological distress. Physical activity is generally safe for this population and may alleviate symptom burden. Yet, limited interventions are tailored to the unique and needs and preferences of this population. This study aims to evaluate the acceptability and feasibility of a mindfulness- and acceptance-based physical activity program designed to support mental, social, and spiritual well-being among people with metastatic breast cancer. A single group, pretest-posttest trial (N=38) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.

Вмешательства

• Поведенческое Acceptance- and mindfulness-based physical activity promotion
  This intervention will be delivered over the course of up to 8-12 weeks. It will include: 1. the provision of a wearable physical activity tracker 2. empirically supported behavior change techniques for promoting physical activity 3. Acceptance and Commitment Therapy-informed didactic content centered on promoting physical activity 4. a social component with game design elements reflecting acceptance and mindfulness practices (i.e., the ability to share responses to "Weekly Challenges" and vie

Первичные конечные точки

• Semi-structured Interviews [Срок оценки: Week 9]
• Perceived ease of use [Срок оценки: Week 9]
• Perceived Usefulness [Срок оценки: Week 9]
• Enjoyability - Face Valid Questions [Срок оценки: Week 9]
• Enjoyability - Interest/Enjoyment Subscale [Срок оценки: Week 9]
• Feasibility of the Program - Study Retention [Срок оценки: Week 9]
• Feasibility of the Program - Adherence [Срок оценки: Week 9]
• Feasibility of Collecting Biological Samples [Срок оценки: Week 9]

Критерии участия

Критерии включения

• having been diagnosed with metastatic breast cancer
• medical clearance from healthcare provider to participate in this study
• life expectancy of at least 6 months as per the participant's healthcare provider
• Eastern Cooperative Oncology Group performance status of or 0 or 1
• being willing and able to use a smartphone and web interface with or without assistance; if assistance is needed, it must be readily available
• adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report
• adequate motor capacity to use a smartphone and web interface as indicated by self-report
• willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes as needed
• completed baseline survey

Критерии исключения

• contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease noted by the patient's treating healthcare provider)
• presence of bone metastases deemed unstable by the treating healthcare provider.
• untreated brain metastases
• history of dementia or other major neurocognitive disorder
• received a diagnosed of Major Depressive Disorder within the previous 6 months
• received a diagnosis of a major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study
• currently hospitalized
• enrolled in hospice
• inability to speak, read, and write in English at the 7th grade level

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

• TSET Health Promotion Research Center — Oklahoma City

Идентификаторы

NCT: NCT07238023 · 18941P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗