Clinical trial NCT06427473: Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors
Official title: Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Weight Loss
Keywords: weight management
breast cancer survivors
mindfulness
Food Frequency Questionnaire
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Physiological indicator I
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: Physiological indicator II
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: Physiological indicator III
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: Physiological indicator IV
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: Food Intake Frequency
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: Mindful Awareness Attention
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
Secondary outcomes:
measure: Weight Efficacy Lifestyle Questionnaire
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
measure: Breast Cancer-Specific Quality of Life Questionnaire
timeFrame: baseline, 8 weeks, 24 weeks, 48 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: