Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND Trial
- Conditions
- 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 b...
- 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.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
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18 years of age or older.
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Previous diagnosis of stage I-III breast cancer in the past 5 years at the time of enrollment.
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No evidence of current, recurrent or metastatic disease.
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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.
- Rationale: these treatments are allowed as the majority of early stage breast cancer survivors receive at least one of these therapies for one or more years following diagnosis; our goal is to test this intervention in a population where the findings will be generalizable to a large population of breast cancer survivors).
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Access to phone for study contacts.
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Access to smartphone, tablet, or computer and internet to attend online program.
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Willing and able to complete all study activities after randomization, including completing surveys online, at-home, and over the telephone assessments.
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Able to understand and willing to sign written informed electronic (e) consent in English (note: though Dr. Greenlee's research group has conducted many trials in Spanish-speaking populations, we did not have the funding to develop and test the intervention in the Spanish language; should the MIND program show evidence of preliminary efficacy we will seek funding to develop and test the intervention in Spanish.).
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Eastern Cooperative Oncology Group (ECOG) status of 0-2.
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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.
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Participants must consume < 5 servings of fruits and vegetables per day as assessed by a brief questionnaire.
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Physician approval to participate in the MIND program dietary intervention.
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At the time of enrollment, women must not be pregnant or lactating or planning to become pregnant in the next 6 months.
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 comp...
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