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

Trial Summary

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 data supports the effectiveness of the Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program for breast cancer survivors?

Research shows that mindfulness-based programs can help breast cancer survivors by reducing stress, improving sleep, and encouraging healthier eating habits. A study on a similar program, SOAR, found that participants improved their mindful eating practices, which can lead to better food choices and potentially support cancer risk reduction. ^{1 2 3 4 5}

Is the Mindfulness Intervention for Breast Cancer Survivors safe?

Mindfulness interventions, like the ones studied in breast cancer survivors, generally focus on stress reduction and mindful eating, and are considered safe for participants. These programs have been used in various studies without reports of harmful effects, suggesting they are safe for human use. ^{1 2 5 6 7}

How is the MIND program treatment different from other treatments for breast cancer survivors?

The MIND program is unique because it combines mindfulness practices with nutritional education in a digital kitchen setting, focusing on mindful eating to improve food choices and eating experiences for breast cancer survivors. This approach is different from traditional treatments as it integrates behavioral strategies with culinary medicine to promote sustainable healthy eating habits. ^{1 2 6 8 9}

What is the purpose of this trial?

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.

Research Team

Heather Greenlee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

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

I was diagnosed with stage I-III breast cancer within the last 5 years.

Timeline

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness-based stress reduction for women with early-stage breast cancer receiving radiotherapy. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Survivors Overcoming and Achieving Resiliency (SOAR): Mindful Eating Practice for Breast Cancer Survivors in a Virtual Teaching Kitchen. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]

5. Scotland pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized wait-list controlled trial of feasibility and efficacy of an online mindfulness-based cancer recovery program: the eTherapy for cancer applying mindfulness trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]

9. England 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. [2022]