Mindful Eating in Breast Cancer Survivors: A Pilot Study in Türkiye

NCT07007104 | Completed

• 1 other identifier: 2025-CancerStudy
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Change in Intuitive Eating Score (IES-2 Total)

  The Intuitive Eating Scale-2 (IES-2) is a validated tool measuring reliance on internal cues and rejection of dieting. Higher scores reflect greater intuitive eating behavior.

  Baseline and 6 months post-intervention

• Change in Mindful Eating Score (MEQ-30 Total)

  The MEQ-30 evaluates domains such as awareness, emotional eating, disinhibition, and responsiveness to hunger cues. Higher scores indicate stronger mindful eating behaviors.

  Baseline and 6 months post-intervention

Secondary Outcomes (3)

• Change in Body Fat Mass (kg)

  Baseline and 6 months

• Change in Fat-Free Mass (kg)

  Baseline and 6 months

• Change in Waist Circumference (cm)

  Baseline and 6 months

Study Arms (2)

Mindful Eating Intervention + Treatment as Usual (MEI + TAU)

EXPERIMENTAL

Participants in this group received six structured sessions of a mindful eating intervention over a defined period, each lasting 60-90 minutes. The intervention was delivered by a registered dietitian certified in both Mindful Eating Certificate (The Center of Mindful Eating, EatRight Certified, 2023) and Mindfulness-Based Eating Awareness Training (MB-EAT) (Mindful Eating Training Institute, 2019). These sessions aimed to improve awareness of hunger and satiety cues, reduce emotional eating, and promote healthier eating behaviors. In addition to the behavioral sessions, participants also received standard post-treatment care, including individualized nutritional counseling by an oncology dietitian.

Behavioral: Mindful Eating Intervention; Behavioral: Oncology Nutrition Counseling

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants in this group received standard survivorship care, which included individualized nutritional education and counseling delivered by an oncology dietitian. They did not participate in any mindful eating-specific behavioral intervention. This group served as the comparator to evaluate the added effect of the structured mindful eating program.

Behavioral: Oncology Nutrition Counseling

Interventions

Mindful Eating Intervention BEHAVIORAL

The mindful eating intervention consisted of six structured group sessions delivered over a six-week period, each lasting approximately 60-90 minutes. The sessions were led by a registered dietitian certified in both Mindful Eating (The Center of Mindful Eating, EatRight Certified, 2023) and Mindfulness-Based Eating Awareness Training (MB-EAT, 2019). The curriculum was designed to improve participants' awareness of hunger and satiety cues, reduce emotional eating, enhance eating satisfaction, and foster non-judgmental eating practices. Each session incorporated guided mindfulness practices, cognitive-behavioral techniques, and experiential activities such as sensory-focused eating. The intervention was provided in addition to standard post-treatment care, which included nutritional counseling by an oncology dietitian.

Mindful Eating Intervention + Treatment as Usual (MEI + TAU)

Oncology Nutrition Counseling BEHAVIORAL

Participants in this group received individualized nutrition counseling and education from a registered oncology dietitian as part of standard post-treatment care for breast cancer survivors. The counseling focused on balanced eating, long-term weight management, and general lifestyle guidance based on survivorship needs. No additional behavioral or mindful eating interventions were delivered.

Mindful Eating Intervention + Treatment as Usual (MEI + TAU); Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead
• Acibadem Altunizade Hospital, Istanbul: collaborator

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: May 3, 2022
• Primary Completion: February 25, 2024
• Study Completion: May 2, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)