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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06603 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0020593 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Apex Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | Participate in the MIND program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diet Quality (Healthy Eating Index-2015) Score | 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Greenlee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2024 | Mar 3, 2026 |
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| Best Practice |
| Other |
Participate in SOC |
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| Electronic Medical Record | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Daily servings of fruit and vegetables | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Frequency of cooking at home | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Anxiety | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Depression | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Cognitive function | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Sleep disturbance | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| Pain interference | 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. | Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm) |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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