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

Not Applicable

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

• Registration Number: NCT06643455
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-16
• Status Verified: 2025-01
• Study Start: 2025-05-16
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-01-14
• Study Completion: 2026-01-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 zolendronic acid.
• 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, and over the telephone assessments.
• 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 not be actively smoking within the past 30 days. Active smoking is defined as any smoking, even a puff. Participants who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for participants to stop smoking than it is to change their dietary patterns. If identified as actively smoking, the individual will be referred to the local resources, Washington State Quitline (1-800-QUIT-NOW), ICanQuit.org, Quit2Heal.org, the national resource, Centers for Disease Control and Prevention (CDC) "Quit Now" phone line which supports smoking cessation, or the NIH quit support website "SmokeFree.gov.
• Participants must consume < 5 servings of fruits and vegetables per day as assessed by a brief questionnaire.
• Physician approval to participate in the MIND program dietary intervention.
• At the time of enrollment, women must not be pregnant or lactating or planning to become pregnant in the next 6 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Accrued (Feasibility)	Up to 12 months	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.
Engagement (Feasibility)	Up to 12 weeks	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.
Retention (Feasibility)	Up to 12 weeks	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.
Acceptability of Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program	Up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Diet Quality (Healthy Eating Index-2015) Score	Baseline to 6 weeks	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.
Daily servings of fruit and vegetables	Baseline to 6 weeks	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.
Frequency of cooking at home	Baseline to 6 weeks	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.
Anxiety	Up to 6 weeks	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.
Depression	Baseline to 6 weeks	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.
Cognitive function	Baseline to 6 weeks	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.
Sleep impairment	Baseline to 6 weeks	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.
Pain interference	Baseline to 6 weeks	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States