Anatomic Stage I Breast Cancer AJCC v8NCT06643455
Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND Trial
A study testing Behavioral Dietary Intervention, Best Practice and Electronic Medical Record in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Behavioral Dietary Intervention, Best Practice and Electronic Medical Record
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) Study: A Pilot and Feasibility Study
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.
Read the 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.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Behavioral Dietary Intervention, Best Practice, Electronic Medical Record, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary InterventionBehavioural
Participate in the MIND program
Best PracticeOther
Also called standard of care, standard therapy
Participate in SOC
Electronic Medical RecordOther
Also called Computer Based Patient Record, EMR, EMR (electronic medical record)
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Electronic Medical Record; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 May 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Why it stopped: Difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Apex Foundation
- Responsible party
- Sponsor
- Investigators
- Heather Greenlee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643455
- Sponsor's protocol ID
- RG1124573
- Other IDs
- NCI-2024-06603, 0020593
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) Study: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06643455
- Acronym / sponsor ID
- RG1124573
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Apex Foundation
- Study start
- 16 May 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (MIND program) | Experimental | Behavioral: Behavioral Dietary Intervention, Other: Electronic Medical Record, Other: Questionnaire AdministrationPatients 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) | Active comparator | Other: Best Practice, Other: Electronic Medical Record, Other: Questionnaire AdministrationPatients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Dietary InterventionParticipate in the MIND program | Behavioural | Arm A (MIND program) |
| Best PracticeAlso: standard of care, standard therapyParticipate in SOC | Other | Arm B (waitlist control) |
| Electronic Medical RecordAlso: Computer Based Patient Record, EMR, EMR (electronic medical record)Ancillary studies | Other | Arm A (MIND program), Arm B (waitlist control) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (MIND program), Arm B (waitlist control) |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Change in Diet Quality (Healthy Eating Index-2015) Score
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Daily servings of fruit and vegetables
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Frequency of cooking at home
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Anxiety
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Depression
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Cognitive function
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Sleep disturbance
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Pain interference
Time frame: Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm)
Results and safety
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Greenlee principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary Intervention, Best Practice and Electronic Medical Record in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Accrued (Feasibility) (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.