Clinical trial NCT06643455: Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND Trial
Official title: Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) Study: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Apex Foundation
First posted: 2024-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Accrued (Feasibility)
timeFrame: Up to 12 months
measure: Engagement (Feasibility)
timeFrame: Up to 12 weeks
measure: Retention (Feasibility)
timeFrame: Up to 12 weeks
measure: Acceptability of Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in Diet Quality (Healthy Eating Index-2015) Score
timeFrame: Baseline to 6 weeks
measure: Daily servings of fruit and vegetables
timeFrame: Baseline to 6 weeks
measure: Frequency of cooking at home
timeFrame: Baseline to 6 weeks
measure: Anxiety
timeFrame: Up to 6 weeks
measure: Depression
timeFrame: Baseline to 6 weeks
measure: Cognitive function
timeFrame: Baseline to 6 weeks
measure: Sleep impairment
timeFrame: Baseline to 6 weeks
measure: Pain interference
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather Greenlee
role: PRINCIPAL_INVESTIGATOR
References: