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

NCT06643455 | Active Not Recruiting

• 3 other identifiers: RG1124573NCI-2024-066030020593
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in Diet Quality (Healthy Eating Index-2015) Score

  Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)

• Daily servings of fruit and vegetables

  Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)

• Frequency of cooking at home

  Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)

• Anxiety

  Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)

• Depression

  Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)

Study Arms (2)

Arm A (MIND program)

EXPERIMENTAL

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: Behavioral Dietary Intervention; Other: Electronic Medical Record; Other: Questionnaire Administration

Arm B (waitlist control)

ACTIVE COMPARATOR

Patients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.

Other: Best Practice; Other: Electronic Medical Record; Other: Questionnaire Administration

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Participate in the MIND program

Arm A (MIND program)

Best Practice OTHER

Participate in SOC

Also known as: standard of care, standard therapy

Arm B (waitlist control)

Electronic Medical Record OTHER

Ancillary studies

Also known as: Computer Based Patient Record, EMR, EMR (electronic medical record)

Arm A (MIND program); Arm B (waitlist control)

Questionnaire Administration OTHER

Ancillary studies

Arm A (MIND program); Arm B (waitlist control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Apex Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Electronic Health Records

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Heather Greenlee

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 16, 2024
• Study Start: May 16, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)