Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND Trial

Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) Study: A Pilot and Feasibility Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Behavioral Dietary Intervention; Other: Electronic Medical Record; Other: Best Practice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Behavioral Dietary Intervention; Participate in the MIND program; Other: Electronic Medical Record; Ancillary studies; Other Names: Computer Based Patient Record; EMR; EMR (electronic medical record)
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Electronic Medical Record; Ancillary studies; Other Names: Computer Based Patient Record; EMR; EMR (electronic medical record); Other: Best Practice; Participate in SOC; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Accrued (Feasibility)	Accrual of participants will be measured from date of initiating recruitment until last date of participant enrollment. Accrual will be considered feasible if enrollment goals (n=100 participants enrolled) is achieved in one year from initiation of recruitment.	Up to 12 months
Engagement (Feasibility)	Will be considered feasible with if ≥ 70% of participants completing ≥ 70% of modules and attending ≥ 70% of live question and answer sessions. Baseline and demographics variables will be summarized by descriptive statistics. Binary proportions can be estimated to within 15% with 95% confidence intervals.	Up to 12 weeks
Retention (Feasibility)	Will be considered feasible with if ≥ 70% of participants complete the week 6 food frequency questionnaire. Baseline and demographics variables will be summarized by descriptive statistics. Binary proportions can be estimated to within 15% with 95% confidence intervals.	Up to 12 weeks
Acceptability of Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program	Will be considered feasible with if ≥ 70% of participants state that the MIND program was acceptable, appropriate, and feasible. Baseline and demographics variables will be summarized by descriptive statistics. Binary proportions can be estimated to within 15% with 95% confidence intervals.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diet Quality (Healthy Eating Index-2015) Score	Participant diet quality will be assessed using the Food Frequency Questionnaire (FFQ). The FFQ provides the data that allows for calculating the Healthy Eating Index (HEI)-2015. The range of scores for the HEI-2015 is 0-100. A higher score is considered better and represents meeting more of the recommended dietary guidelines. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Daily servings of fruit and vegetables	Will be assessed using the FFQ. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Frequency of cooking at home	Will be self-reported by patient. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Anxiety	Will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Depression	Will be measured using the PROMIS Depression Short Form. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Cognitive function	Will be measured using the PROMIS Cognitive Function Short Form. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Sleep disturbance	Will be measured using the PROMIS Sleep Impairment Short Form. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Pain interference	Will be measured using the PROMIS Pain Interference Short Form. Binary proportions will be compared between arms using a chi-squared test with the continuity correction. For continuous outcomes, between group comparisons will be made using linear regression methods and adjusting for baseline values.	Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Apex Foundation
• Investigators: Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Records; Medical Records Systems, Computerized; Medical Records; Standard of Care; Practice Guidelines as Topic; Electronic Health Records
• Other Study ID Numbers: RG1124573; NCI-2024-06603 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 0020593 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No