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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2026-01-14

Brief Summary

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This trial tests how well a remotely-delivered nutrition and culinary intervention works to improve diet quality among stage I-III breast cancer survivors. Despite the strong evidence demonstrating the benefits of healthy nutrition on improving cancer outcomes, most breast cancer survivors, do not meet the nutrition recommendations The use of technology in behavioral interventions is proving to be a cost-effective mode of delivering lifestyle education to promote behavior change. The Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program is delivered through a learning management system on the Cook for Your Life platform (cookforyourlife.org). The Cook for Your Life platform is a cancer patient-facing interactive program offering free nutrition and healthy cooking information, recipes, and cooking videos that disseminate evidence-based information on nutrition and cancer survivorship. The MIND program may help improve diet quality and increase fruit and vegetable intake among stage I-III breast cancer survivors.

Detailed Description

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OUTLINE: Patients are randomized to 1 of 2 arms.

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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Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Behavioral Dietary Intervention

Intervention Type BEHAVIORAL

Participate in the MIND program

Electronic Medical Record

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Participate in SOC

Electronic Medical Record

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Dietary Intervention

Participate in the MIND program

Intervention Type BEHAVIORAL

Best Practice

Participate in SOC

Intervention Type OTHER

Electronic Medical Record

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Computer Based Patient Record EMR EMR (electronic medical record)

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apex Foundation

UNKNOWN

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jenny Whitten-Brannon

Role: CONTACT

206.667.5625

Facility Contacts

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Jenny Whitten-Brannon

Role: primary

206-667-5625

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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