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Набор скоро начнётся NCT07179809

Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer

Без фазы С лечением Metastatic Breast 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: Demographics/Lifestyle Survey.
Кому может быть актуально
Состояния в реестре: Metastatic Breast Cancer. Базовые параметры: от 18 лет · Женщины.
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 →
Официальное название

Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence

Обзор

The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.

Подробное описание

Primary Objective:

Assess the feasibility of delivering the ACLP, ACLP-LC, and ACLP-LC-IHC programs in stable HR+/HER2- MBC survivors. Feasibility criteria will include the percent of eligible patients who consent to participate (feasibility is defined as 30% of those approached and are eligible end up consenting) and study retention by the last follow-up (feasibility is defined as 50% of those randomized remaining in the study and who participated in at least 75% of online sessions). Our working hypothesis is that the provision of the evidence-based, mHeath ACLP with the Learning Circle support group, with or without individual health coaching, is feasible in patients with stable HR+/HER2- MBC.

Secondary Objectives:

1. Explore changes in targeted health behaviors of diet, exercise, and stress management. 2. Examine changes in patient-reported outcomes (PROs), including: QOL, fatigue, sleep disturbances, mental health, social support, mindfulness, and stages of change. 3. Examine if there are group differences in post-intervention albumin, vit D, and magnesium levels.

OUTLINE: Patients are first randomized to 1 of 3 groups.

GROUP 1 (ACLP): Patients receive an outline of tasks and complete ACLP interactive exercise and activity modules on their own over 8 weeks and receive calls weekly for 8 weeks.

GROUP 2 (ACLP-LC): Patients complete ACLP interactive exercise and activity modules and attend online LC group sessions over 90 minutes once weekly (QW) for 8 weeks. Patients receive informational emails weekly prior to scheduled sessions.

GROUP 3 (ACLP-LC-IHC): Patients participate in the 8-week ACLP-LC program just like group 2. In addition, starting two weeks after the end of the program, they receive IHC sessions over 30-60 minutes for up to 6 sessions over 3 months.

Additionally, patients undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed at 3 and 6 months.

Вмешательства

  • Другое Demographics/Lifestyle Survey
    Participants will complete all sessions and instruments

Первичные конечные точки

  • Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year.]

Критерии участия

Критерии включения

  • Patients with HR+/HER2 negative MBC
  • On first- or second-line treatment
  • Life expectancy at least 12 months
  • Only females
  • Age 18 years or older
  • Able to read, write, and speak English
  • Willingness to follow protocol requirements
  • Have a smartphone with access to cellular service or computer access with internet service
  • Oriented to person, place, and time
  • Consume less than 3 servings of fruit and vegetable/day
  • Engage in less than 150 minutes moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
  • Engage in a mind-body practice less than 4 times a month

Критерии исключения

  • Another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
  • Any major thought disorder (e.g., schizophrenia, dementia)
  • Communication barriers (e.g., hard of hearing)
  • Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)
  • Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • The University of Texas M. D. Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT07179809 · 2025-0951 · NCI-2025-06338

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗