Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND Trial
NCT ID: NCT06643455
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-05-16
2026-01-14
Brief Summary
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Detailed Description
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ARM A (INTERVENTION): Patients participate in the MIND program consisting of self-paced online education on nutrition, chef demo skills-building cooking, and mindfulness practice over 4 hours weekly for 6 weeks.
ARM B (WAITLIST CONTROL): Patients participate in standard of care (SOC) for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.
After completion of study intervention, patients are followed up at 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A (MIND program)
Patients participate in the MIND program consisting of self-paced online education on nutrition, chef demo skills-building cooking, and mindfulness practice over 4 hours weekly for 6 weeks.
Behavioral Dietary Intervention
Participate in the MIND program
Electronic Medical Record
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm B (waitlist control)
Patients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.
Best Practice
Participate in SOC
Electronic Medical Record
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Dietary Intervention
Participate in the MIND program
Best Practice
Participate in SOC
Electronic Medical Record
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous diagnosis of stage I-III breast cancer in the past 5 years at the time of enrollment.
* No evidence of current, recurrent or metastatic disease.
* At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. The following which are allowed: HER2-targeted therapies, CDK4/6 inhibitor (abemaciclib or ribociclib), endocrine therapy (aromatase inhibitors, ovarian suppression therapy, and tamoxifen), PARP inhibitors (olaparib), and bisphosphonates.
* Access to phone for study contacts.
* Access to smartphone, tablet, or computer and internet to attend online program.
* Willing and able to complete all study activities after randomization, including completing surveys online, at-home, or over the telephone.
* Able to understand and willing to sign written informed electronic (e) consent in English
* Eastern Cooperative Oncology Group (ECOG) status of 0-2.
* Participants must consume \< 5 servings of fruits and vegetables per day as assessed by a brief questionnaire.
* At the time of enrollment, women must not be pregnant or lactating or planning to become pregnant in the next 6 months.
18 Years
ALL
No
Sponsors
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Apex Foundation
UNKNOWN
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Heather Greenlee
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-06603
Identifier Type: REGISTRY
Identifier Source: secondary_id
0020593
Identifier Type: OTHER
Identifier Source: secondary_id
RG1124573
Identifier Type: -
Identifier Source: org_study_id
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