Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer

Официальное название

Influence of Mind-Body Interventions on Cancer-Related Symptom Management in Survivors

Обзор

This clinical trial studies how well mind-body interventions work in improving quality of life (QOL), stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer. For many cancer survivors, the experience of cancer extends well beyond the completion of therapy. Common long-term effects include fatigue, cognitive impairment, anxiety, depression, sleep disturbance, and diminished physical function, all of which contribute to reduced QOL and overall health. Yoga, a mind-body intervention, utilizes breathwork, meditation, and gentle movement to help reduce activity in the body's nervous system. Breathwork and meditation have been shown to improve heart rate variability (a measure of the body's ability to adapt to stress). Movement-based practices may offer added benefit by supporting coordination and physical resiliency, aspects that are often reduced after cancer treatment and can lead to decreased QOL. This trial may help researchers determine whether a mind-body intervention that includes breathwork and meditation, as well as an intervention that includes breathwork and meditation plus gentle movement can work to improve QOL, stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer.

Подробное описание

PRIMARY OBJECTIVE:

I. Pilot test video and/or audio content consisting of six, 15-minute breathwork and meditation videos/audio, and six, 15-minute guided, gentle movement videos developed for this intervention for feasibility and acceptability, and provide preliminary data on QOL in cancer (breast, colon, endometrial, and prostate) survivors using patient-reported outcomes measurements completed at pre- and post- intervention.

SECONDARY OBJECTIVES:

I. Evaluate program satisfaction using structured questionnaires for all participants at post-intervention.

II. Identify perceived barriers, evaluate facilitators, and identify recommendations for future scaling and delivery in varied survivorship settings

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Вмешательства

• Другое Media Intervention
  View breathwork and meditation videos
• Другое Media Intervention
  View breathwork, meditation and gentle yoga videoos
• Процедура Mind-body intervention
  Complete breathwork exercises
• Процедура Meditation Therapy
  Complete Meditation exercises

Первичные конечные точки

• Change in quality of life [Срок оценки: Baseline up to 6 weeks]

Вторичные конечные точки (1)

• Adherence Rate [Срок оценки: UP to 6 weeks]

Критерии участия

Критерии включения

• Received a diagnosis of invasive, non-metastatic breast, colorectal, endometrial, or prostate cancer within the past 12 months
• Have completed active anti-cancer therapy (hormonal, bisphosphonate, or androgen therapy is allowed)
• Able to safely participate in light-weight physical activity (e.g. gentle yoga)

Критерии исключения

• Individuals with skeletal instabilities, cardio-pulmonary comorbidities, or other conditions that may preclude safe participation in light physical activity
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements

• Any condition that, in the Investigator's opinion, deems the participant an unsuitable candidate
• Unable to complete survey questionnaires in English

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07745023 · I-4896826

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗