Mindfulness Intervention for Breast Cancer Survivors

Overseen By Jenny Whitten-Brannon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Active smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an online mindfulness and nutrition program can help breast cancer survivors improve their diet. Participants will either join the MIND program (Mindfulness Intervention for Nutrition in the Digital Kitchen), which includes self-paced lessons on nutrition and cooking, or remain on a waitlist for six weeks. The goal is to determine if the program can boost fruit and vegetable intake and overall diet quality. This trial may suit individuals who have had stage I-III breast cancer in the past five years and consume fewer than five servings of fruits and vegetables daily. As an unphased trial, it offers a unique opportunity to explore innovative ways to enhance dietary habits and overall well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, certain therapies like HER2-targeted therapies, CDK4/6 inhibitors, endocrine therapy, PARP inhibitors, and zolendronic acid are allowed, so you may not need to stop these if you are taking them.

What prior data suggests that the MIND program is safe for breast cancer survivors?

Research has shown that mindfulness programs, such as the Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program, are generally safe for breast cancer survivors. These programs teach healthy eating and mindfulness in an online format. Studies on similar programs have found that participants usually have a positive experience without major side effects.

The MIND program aims to improve diet quality by encouraging participants to eat more fruits and vegetables. As an online education program, it does not involve any drugs or medical procedures, which reduces the risk of side effects. Prospective participants should consult their healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program because it offers a holistic approach, combining nutrition education, cooking skills, and mindfulness practice, which is a departure from the usual focus on medication or standard care treatments for breast cancer survivors. Unlike standard care, which typically emphasizes medical follow-up and physical health, the MIND program empowers patients to engage in self-paced learning and skill-building in their own homes, promoting long-term lifestyle changes. This innovative approach could enhance overall well-being and recovery by addressing mental and emotional health alongside physical nutrition, making it an appealing complement to traditional care methods.

What evidence suggests that the MIND program is effective for improving diet quality in breast cancer survivors?

Research has shown that mindfulness and nutrition programs can help breast cancer survivors adopt healthier eating habits. Participants in similar programs have increased their intake of fruits and vegetables. Mindful eating has been associated with improved dietary choices. In this trial, participants in Arm A will engage in the MIND program, which includes online nutrition lessons, cooking demonstrations, and mindfulness exercises. This approach aims to assist breast cancer survivors in making healthier food choices, potentially leading to better overall health. Meanwhile, participants in Arm B will follow standard care for six weeks and may optionally access the MIND program afterward. ^{1 2 3 5 6}

Who Is on the Research Team?

Heather Greenlee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for stage I-III breast cancer survivors. It's testing a digital nutrition and cooking program to see if it can improve their diets. Participants need access to the internet and must be willing to use the Cook for Your Life platform.

Inclusion Criteria

Able to understand and willing to sign written informed electronic (e) consent in English

I have a smartphone, tablet, or computer with internet for online programs.

Participants must consume < 5 servings of fruits and vegetables per day as assessed by a brief questionnaire

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Arm A engage in the MIND program with online education, cooking demos, and mindfulness practice for 6 weeks. Arm B participants receive standard care for 6 weeks.

6 weeks

Follow-up

Participants are monitored for engagement, retention, and acceptability of the MIND program, as well as changes in diet quality and other health metrics.

6 weeks

Optional Extension

Participants in Arm B may optionally receive access to the MIND program after the initial 6-week study period.

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program

Trial Overview

The MIND Trial is examining whether a mindfulness-based dietary intervention delivered online can help breast cancer survivors eat better. The program includes healthy cooking information, recipes, and videos on the Cook for Your Life website.

How Is the Trial Designed?

Group I: Arm A (MIND program) Experimental Treatment 3 Interventions

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.

Group II: Arm B (waitlist control) Active Control 3 Interventions

Patients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Apex Foundation

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Mindful awareness practices (MAPs) significantly reduced intrusive thoughts and worry in younger breast cancer survivors, and increased positive affect and a sense of meaning in life, with effects lasting up to 3 months after the intervention.

Compared to a wait-list control group, MAPs also showed a decrease in proinflammatory gene expression, suggesting potential immune benefits, while survivorship education (SE) also improved psychological outcomes but did not affect inflammation as significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. Bower, JE., Partridge, AH., Wolff, AC., et al.[2023]

The modified mindfulness-based stress reduction (MBSR) program for breast cancer patients showed promising effects on reducing psychological distress and improving quality of life, with significant improvements noted in distress, general wellbeing, and fatigue-related quality of life after 8 weeks.

Although the study did not meet its feasibility goals for enrollment and retention, 66.7% of participants completed at least 7 out of 8 sessions, indicating potential interest and benefit in mindfulness interventions for cancer recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. Salvador, C., Mark, P., Hoenemeyer, T., et al.[2022]

A 4-week mindfulness program for 36 cancer survivors led to significant reductions in perceived stress and sedentary time, along with improvements in sleep quality and daily physical activity after the intervention.

The study suggests that abbreviated mindfulness interventions are feasible and effective for cancer survivors, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. Wirth, MD., Franco, R., Wagner Robb, S., et al.[2019]

The mobile mindfulness-based stress reduction program (mMBSR(BC)) was found to be feasible and acceptable for breast cancer survivors, with significant improvements in psychological and physical symptoms after 6 weeks of use.

Participants showed medium to large effect size improvements in symptoms such as depression, anxiety, stress, and quality of life, indicating that this mobile intervention can effectively reduce symptom burden during the survivorship phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors. Lengacher, CA., Reich, RR., Ramesar, S., et al.[2022]

Mindfulness-based therapy (MBT) significantly reduces anxiety, depression, fear of recurrence, and fatigue in breast cancer patients, based on a meta-analysis of seven studies involving 951 participants.

MBT also improves emotional well-being, physical function, and physical health in these patients, suggesting it could be a valuable complementary treatment alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. Zhang, J., Xu, R., Wang, B., et al.[2022]

Citations

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fredhutch.org

fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15240.mindfulness-intervention-for-improving-nutrition-in-the-digital-kitchen-among-stage-i-iii-breast-cancer-survivors-mind-trial.html

Mindfulness Intervention for Nutrition in the Digital Kitchen ...

This trial tests how well a remotely-delivered nutrition and culinary intervention works to improve diet quality among stage I-III breast cancer survivors.

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Mindfulness Intervention for Improving Nutrition in the ...

This clinical trial tests how well a remotely-delivered nutrition and culinary intervention works to improve diet quality among stage I-III breast cancer ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10574766/

Mindful Eating Practice for Breast Cancer Survivors ...

We examined mindful eating in breast cancer survivors following a 9-week, multidisciplinary virtual teaching kitchen intervention called ...

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ctv.veeva.com/study/mindfulness-intervention-for-improving-nutrition-in-the-digital-kitchen-among-stage-i-iii-breast-can

Mindfulness Intervention for Improving Nutrition in the Digital ...

The MIND program may help improve diet quality and increase fruit and vegetable intake among stage I-III breast cancer survivors.

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withpower.com

withpower.com/trial/phase-breast-neoplasms-2025-6b12a

Mindfulness Intervention for Breast Cancer Survivors

This trial tests how well a remotely-delivered nutrition and culinary intervention works to improve diet quality among stage I-III breast cancer survivors.

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mdpi.com

mdpi.com/2072-6643/15/19/4205

Mindful Eating Practice for Breast Cancer Survivors in a ...

We examined mindful eating in breast cancer survivors following a 9-week, multidisciplinary virtual teaching kitchen intervention called Survivors Overcoming ...