Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' .

Официальное название

Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' (EXCAP-hEAT) Among Breast Cancer Survivors Receiving Adjuvant Endocrine Therapy.

Обзор

This study evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. The study will assess changes in patient reported outcomes, functional measures, and overall adherence to the program. Findings will help determine whether this approach is practical and potentially beneficial for improving health related outcomes in this population.

Вмешательства

• Поведенческое EXCAP Exercise Program
  Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.
• Поведенческое 10-Hour Healthy Eating Timeframe (hEAT)
  Participants will self-select and maintain a daily eating window of 10 hours or less for 6 weeks, with timing of first and last meals recorded daily.

Первичные конечные точки

• Proportion of Participants Meeting Pre-Specified Adherence Criteria [Срок оценки: Baseline to Day 42]

Вторичные конечные точки (6)

• Mean Change in Brief Fatigue Inventory Total Score [Срок оценки: Baseline to Day 42]
• Mean Change in Multidimensional Fatigue Symptom Inventory Total Score [Срок оценки: Baseline to Day 42]
• Mean Change in Body Mass Index [Срок оценки: Baseline to Day 42]
• Mean Change in 30-Second Bicep Curl Test Repetitions [Срок оценки: Baseline to Day 42]
• Mean Change in 30-Second Chair Stand Test Repetitions [Срок оценки: Baseline to Day 42]
• Mean Change in Estimated Submaximal VO2 [Срок оценки: Baseline to Day 42]

Критерии участия

Критерии включения

• Must be aged 18 years or older
• Must have a confirmed diagnosis of breast cancer (stage I-IIIC)
• Must have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 2 - 120 months prior to enrolling,
• Must be prescribed adjuvant endocrine therapy,
• Must have a baseline level of fatigue, as determined by reporting a score of 4 or higher on the Symptom Inventory
• Must have a body mass index greater than or equal to 25 kg per meter squared
• Must have the ability to ambulate independently
• Must be willing and able to participate in home-based exercise and eating timeframe intervention
• Must have the ability to read and understand the English language,

Критерии исключения

• Must not have metastatic or recurrent breast cancer
• Must not be currently receiving chemotherapy or radiation therapy
• Must not have a medical condition that would preclude safe participation in intervention or study procedures
• Must not be pregnant, or planning to become pregnant during the study period
• Must not be in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form,
• Must not have any condition that in the opinion of the investigator would interfere with participation or safety
• Must not be currently using, or plan to initiate use of prescription or over-the-counter weight-loss medications

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

• Wilmot Cancer Institute — Rochester

Идентификаторы

NCT: NCT07529353 · STUDY00010857

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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