Clinical trial NCT07007104: Mindful Eating in Breast Cancer Survivors: A Pilot Study in Türkiye
Official title: Exploring the Impact of Mindful Eating: A Pilot Study Among Breast Cancer Survivors in Türkiye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivorship
Eating Behavior
Weight Management
Mindful Eating Intervention
Keywords: Behavioral intervention
Breast cancer survivors
Eating behavior
Intuitive eating
Mindful eating
Weight management
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Acibadem Altunizade Hospital, Istanbul
First posted: 2025-06-05
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explore whether a mindful eating intervention can improve eating behaviors and support sustainable weight management among female breast cancer survivors in Türkiye who have completed active treatment.

The main questions it aims to answer are:

* Can a structured mindful eating program improve intuitive and mindful eating behaviors?
* Does the intervention lead to favorable changes in body weight, BMI, waist circumference, and fat mass compared to usual care?

Researchers will compare a group receiving a 6-session mindful eating intervention plus treatment-as-usual (MEI + TAU) to a treatment-as-usual (TAU) control group to see if the intervention provides additional benefits on eating behaviors and body composition.

Participants will:

* Attend six 60-90 minute group sessions on mindful eating delivered by trained professionals
* Receive tailored nutrition education from an oncology dietitian
* Complete validated questionnaires (IES-2 and MEQ-30) and anthropometric assessments at baseline and follow-up

Detailed description: This randomized controlled pilot study investigates the effects of a six-session mindful eating intervention (MEI) on eating behaviors and body composition among female breast cancer (BC) survivors in Türkiye. Participants were recruited from a medical oncology clinic and were eligible if they had completed surgery, chemotherapy, and radiotherapy, with or without ongoing hormone therapy, at least six months prior to enrollment. A total of 25 participants were randomly assigned to one of two groups: (1) MEI combined with treatment-as-usual (MEI + TAU, n = 12) and (2) treatment-as-usual alone (TAU, n = 13).

The MEI consisted of six weekly 60-90 minute sessions led by a trained mindful eating facilitator and a registered dietitian with oncology experience. Sessions addressed themes such as recognizing hunger and satiety cues, slowing down during meals, managing emotional eating, and enhancing sensory awareness. Participants also received individualized nutritional counseling based on their anthropometric data and dietary habits.

Data were collected at baseline and multiple follow-up points across six months. Outcomes included body weight, BMI, waist circumference, fat mass, and scores from two validated behavioral questionnaires: the Intuitive Eating Scale-2 (IES-2) and the Mindful Eating Questionnaire-30 (MEQ-30). Body composition was assessed using bioelectrical impedance analysis (BIA), and statistical analysis was performed to evaluate within-group and between-group changes over time.

Preliminary results suggest that participants in the MEI + TAU group experienced significant improvements in intuitive eating scores, particularly in reliance on hunger/satiety cues and reduced emotional eating. Mindful eating scores also increased across several subscales, and reductions in waist circumference were more pronounced in the intervention group. These findings indicate that mindful eating interventions may support sustainable weight management and improved eating behaviors in breast cancer survivors. Further large-scale studies are warranted to confirm these outcomes and explore long-term effects on survivorship and recurrence risk.

Eligibility criteria: Inclusion Criteria:

* Female individuals aged 18 years and older
* History of breast cancer diagnosis (any subtype)
* Completion of active cancer treatment (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior to enrollment
* Ability to participate in group-based behavioral sessions
* Ability to provide informed consent

Exclusion Criteria:

* Completion of cancer treatment less than 6 months prior to enrollment
* Presence of metastatic disease or active cancer recurrence
* Concurrent diagnosis of another major illness affecting dietary behavior (e.g., eating disorder, severe gastrointestinal disease)
* Cognitive impairment or psychiatric condition that limits ability to participate in behavioral sessions
* Inability or unwillingness to attend group intervention sessions

Primary outcomes:
measure: Change in Intuitive Eating Score (IES-2 Total)
timeFrame: Baseline and 6 months post-intervention
measure: Change in Mindful Eating Score (MEQ-30 Total)
timeFrame: Baseline and 6 months post-intervention
Secondary outcomes:
measure: Change in Body Fat Mass (kg)
timeFrame: Baseline and 6 months
measure: Change in Fat-Free Mass (kg)
timeFrame: Baseline and 6 months
measure: Change in Waist Circumference (cm)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem Altunizade Hospital
Study officials:
References: