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NCT Number: NCT06643455

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

behavioral dietary intervention

Behavioral

Participate in the MIND program

Best Practice

Other

Participate in SOC

Other names: standard of care, standard therapy

Electronic Medical Record

Other

Ancillary studies

Other names: Computer Based Patient Record, EMR, EMR (electronic medical record)

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Number of Participants Accrued (Feasibility)

    Time frame: 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.

  2. Engagement (Feasibility)

    Time frame: 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.

  3. Retention (Feasibility)

    Time frame: 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.

  4. Acceptability of Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program

    Time frame: 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 outcomes

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

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

    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.

  2. Daily servings of fruit and vegetables

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

    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.

  3. Frequency of cooking at home

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

    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.

  4. Anxiety

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

    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.

  5. Depression

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

    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.

  6. Cognitive function

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

    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.

  7. Sleep disturbance

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

    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.

  8. Pain interference

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

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Apex Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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