Breast Cancer SurvivorshipMIND-BRNCT07007104
Mindful Eating in Breast Cancer Survivors: A Pilot Study in Türkiye
A study testing Mindful Eating Intervention and Oncology Nutrition Counseling in people with Breast Cancer Survivorship and Eating Behavior, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivorship, Eating Behavior, Weight Management
- What is being tested?
- Mindful Eating Intervention and Oncology Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2022to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Impact of Mindful Eating: A Pilot Study Among Breast Cancer Survivors in Türkiye
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:
Read more
- 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
Read the 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.
- Conditions
- Breast Cancer Survivorship, Eating Behavior, Weight Management, Mindful Eating Intervention
- Being tested
- Mindful Eating Intervention, Oncology Nutrition Counseling
- Keywords
- Behavioral intervention, Breast cancer survivors, Eating behavior, Intuitive eating, Mindful eating, Weight management
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Eating InterventionBehavioural
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.
Oncology Nutrition CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Oncology Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 months post-intervention
Secondary outcomes (3)
Change in Body Fat Mass (kg)
Fat mass was assessed using bioelectrical impedance analysis (BIA, Tanita MC780). Measurements were taken during individual sessions with an oncology dietitian at baseline and after 6 months.
Measured: Baseline and 6 months
Change in Fat-Free Mass (kg)
Fat-free mass (lean mass) was measured by BIA during dietitian-led consultations.
Measured: Baseline and 6 months
Change in Waist Circumference (cm)
Waist circumference was measured using standardized tape during sessions with an oncology dietitian to assess changes in central adiposity.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start3 May 2022
- Primary completion25 Feb 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Altunizade Hospital, Istanbul
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007104
- Sponsor's protocol ID
- 2025-CancerStudy
- Acronym
- MIND-BR
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and ethical restrictions. The current study was approved under conditions that limit data use to the research team, and participant-level data were not collected with explicit consent for external sharing. Group-level findings will be reported in scientific publications.
Publications
Bas D, Agir G, Sonmez O, Ones E. Mindful eating as a supportive intervention for breast cancer survivors: a pilot randomized controlled trial. Breast Cancer. 2026 Sep 27. doi: 10.1007/s12282-026-01917-5. Online ahead of print.
PubMed 42801445
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Mindful Eating: A Pilot Study Among Breast Cancer Survivors in Türkiye
- ClinicalTrials.gov ID
- NCT07007104
- Acronym / sponsor ID
- MIND-BR / 2025-CancerStudy
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Acibadem Altunizade Hospital, Istanbul
- Study start
- 3 May 2022 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Eating Intervention + Treatment as Usual (MEI + TAU) | Experimental | Behavioral: Mindful Eating Intervention, Behavioral: Oncology Nutrition CounselingParticipants 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. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Oncology Nutrition CounselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Eating InterventionThe 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. | Behavioural | Mindful Eating Intervention + Treatment as Usual (MEI + TAU) |
| Oncology Nutrition CounselingParticipants 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. | Behavioural | Mindful Eating Intervention + Treatment as Usual (MEI + TAU), Treatment as Usual (TAU) |
Primary outcome
Change in Intuitive Eating Score (IES-2 Total)
Time frame: Baseline and 6 months post-intervention
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.
Change in Mindful Eating Score (MEQ-30 Total)
Time frame: Baseline and 6 months post-intervention
The MEQ-30 evaluates domains such as awareness, emotional eating, disinhibition, and responsiveness to hunger cues. Higher scores indicate stronger mindful eating behaviors.
3 secondary outcomes
Change in Body Fat Mass (kg)
Time frame: Baseline and 6 months
Change in Fat-Free Mass (kg)
Time frame: Baseline and 6 months
Change in Waist Circumference (cm)
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Derived from this study: PubMed 42801445Bas D, Agir G, Sonmez O, Ones E. Mindful eating as a supportive intervention for breast cancer survivors: a pilot randomized controlled trial. Breast Cancer. 2026 Sep 27. doi: 10.1007/s12282-026-01917-5. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and ethical restrictions. The current study was approved under conditions that limit data use to the research team, and participant-level data were not collected with explicit consent for external sharing. Group-level findings will be reported in scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating Intervention and Oncology Nutrition Counseling in people with Breast Cancer Survivorship and Eating Behavior, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intuitive Eating Score (IES-2 Total) (time frame: Baseline and 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.