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临床试验/NCT06427473
NCT06427473已完成不适用

Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Physiological indicator II

研究概览

简要总结

The study addresses the pressing issue of overweight and obesity among breast cancer patients, which exacerbates recurrence rates and mortality risks. Its primary objective is to assess the efficacy of two intervention models, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, in facilitating weight loss, enhancing self-efficacy, mindfulness, and quality of life. The anticipated outcomes include long-term engagement in online self-learning, overcoming the limitations of ineffective self-management learning, and empowering healthcare professionals with scenario-based teaching materials. Through online platforms, patients can learn and review without constraints, ultimately achieving a holistic balance among physical, mental, and spiritual health.

详细描述

[Research Background] Breast cancer ranks first among cancers in women worldwide, with overweight and obesity being one of the high-risk factors for breast cancer. Moreover, overweight individuals within the breast cancer patient population also face higher recurrence rates and mortality risks. Assisting overweight or obese breast cancer women in weight loss to promote their well-being was the initial idea behind this study. The most common weight loss strategies include dietary management and regular exercise. In recent years, more studies have shown that effective weight loss also requires psychological interventions. Therefore, this study will combine dietary, exercise, and mindfulness-related interventions to assist breast cancer patients in more effective weight management.

[Research Objectives] To compare the effectiveness of two intervention measures, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.

[Research Method] The study will involve a quantitative study, which plans to carry out a randomized controlled trial (RCT). This trial will compare the effects of two intervention measures, the DEM model and the DE model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.

[Expected Results] Through the intervention provided by this study, patients can engage in long-term online self-learning and supplementary learning after returning home, reducing the limitations of ineffective self-management learning caused by negative emotions, treatment side effects, and sequelae in the early stages of cancer. Healthcare professionals can also use scenario-based teaching materials produced by this study to guide breast cancer survivors with ineffective weight self-management skills in practicing the necessary skills. Additionally, through online learning, patients can learn and review without pressure, saving time on transportation, easing carbon foot print and relearning effective weight management skills; even if they have faced major life threats in the past, they can turn adversity into blessings, achieving a balance among physical, mental, and spiritual health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • stage I-III breast cancer and completed treatment
  • Body mass index (BMI) is greater than or equal to 24 kg/m2
  • possess a smartphone

排除标准

  • Pregnant or planning to become pregnant within six months
  • Those who are unable to walk

结局指标

主要结局

Physiological indicator II

时间窗: baseline, 8 weeks, 24 weeks, 48 weeks

Waist circumference in centimeter

Food Intake Frequency

时间窗: baseline, 8 weeks, 24 weeks, 48 weeks

Food Frequency Questionnaire

Physiological indicator I

时间窗: baseline, 8 weeks, 24 weeks, 48 weeks

BMI in kg/m2 (weight in kilograms divided by height in meters squared)

Physiological indicator IV

时间窗: baseline, 8 weeks, 24 weeks, 48 weeks

Muscle mass in kilograms

Mindful Awareness Attention

时间窗: baseline, 8 weeks, 24 weeks, 48 weeks

The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.

Physiological indicator III

时间窗: baseline, 8 weeks, 24 weeks, 48 weeks

Body fat in percentage

次要结局

  • Breast Cancer-Specific Quality of Life Questionnaire(baseline, 8 weeks, 24 weeks, 48 weeks)
  • Weight Efficacy Lifestyle Questionnaire(baseline, 8 weeks, 24 weeks, 48 weeks)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(baseline, 8 weeks, 24 weeks, 48 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

I-Ching Hou

Associate Professor

National Yang Ming Chiao Tung University

研究点 (2)

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