Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors
- Conditions
- Weight LossBreast Cancer
- Interventions
- Behavioral: Dietary programBehavioral: Exercise programBehavioral: Mindfulness program
- Registration Number
- NCT06427473
- Lead Sponsor
- National Yang Ming Chiao Tung University
- Brief Summary
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.
- Detailed Description
\[Research Background\] 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- stage I-III breast cancer and completed treatment
- Body mass index (BMI) is greater than or equal to 24 kg/m2
- possess a smartphone
- Pregnant or planning to become pregnant within six months
- Those who are unable to walk
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE model Exercise program subjects participate diet and exercise programs DEM model Mindfulness program subjects participate diet, exercise and mindfulness programs DEM model Exercise program subjects participate diet, exercise and mindfulness programs DEM model Dietary program subjects participate diet, exercise and mindfulness programs DE model Dietary program subjects participate diet and exercise programs
- Primary Outcome Measures
Name Time Method Physiological indicator II baseline, 8 weeks, 24 weeks, 48 weeks Waist circumference in centimeter
Food Intake Frequency baseline, 8 weeks, 24 weeks, 48 weeks Food Frequency Questionnaire
Physiological indicator I baseline, 8 weeks, 24 weeks, 48 weeks BMI in kg/m2 (weight in kilograms divided by height in meters squared)
Physiological indicator IV baseline, 8 weeks, 24 weeks, 48 weeks Muscle mass in kilograms
Mindful Awareness Attention 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 baseline, 8 weeks, 24 weeks, 48 weeks Body fat in percentage
- Secondary Outcome Measures
Name Time Method Breast Cancer-Specific Quality of Life Questionnaire baseline, 8 weeks, 24 weeks, 48 weeks The minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
Weight Efficacy Lifestyle Questionnaire baseline, 8 weeks, 24 weeks, 48 weeks The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire baseline, 8 weeks, 24 weeks, 48 weeks 1. Item 1 to 28 the minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
2. Item 29 to 30 the minimum value is 1 and maximum value is 7, and higher scores mean a better outcome.
Trial Locations
- Locations (1)
National Yang Ming Chiao Tung University
🇨🇳Taipei, Taiwan