Lifestyle Intervention for Metastatic Breast Cancer

(EDC Trial)

Recruiting at 1 trial location

Overseen By Kathleen OConnell, MSW

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-female, No MBC, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how lifestyle changes, such as diet and exercise, affect women with metastatic breast cancer. Participants will either join a program focused on nutrition and physical activity (Lifestyle Intervention) or receive guidance on home and work organization (Attention Control). The researchers aim to assess how these interventions impact body composition, blood health, and overall quality of life. Women with stable metastatic breast cancer who do not currently follow the American Cancer Society’s lifestyle guidelines for cancer survivors might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for women with metastatic breast cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have any recent or planned changes in their cancer treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lifestyle changes, like those being studied, are generally safe for women with metastatic breast cancer (MBC). A previous study found these changes were well-tolerated and could benefit women with MBC. Another review examined exercise programs and found them safe for people with advanced cancer, including those with MBC. This evidence suggests that the lifestyle changes being tested, focusing on diet and exercise, are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how lifestyle changes can impact metastatic breast cancer, offering a fresh perspective beyond traditional treatments like chemotherapy, hormonal therapy, or targeted therapy. Unlike standard approaches that primarily focus on directly attacking cancer cells, this trial investigates the power of nutrition and physical activity to support overall health and potentially improve outcomes for cancer survivors. The trial emphasizes plant-based eating, personalized lifestyle coaching, and the use of tools like Fitbits to encourage active participation and self-monitoring, which could empower patients to take an active role in their health journey.

What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?

Research has shown that lifestyle changes can improve life for people with metastatic breast cancer. In this trial, participants in the Immediate Intervention arm will undergo a 16-week lifestyle intervention focusing on diet and exercise, which studies have found can enhance overall well-being. For example, one study found that participants in a lifestyle program experienced significant improvements in well-being. Another study suggested these changes might also help prevent cancer recurrence and improve survival. Overall, evidence suggests that lifestyle changes can benefit those living with metastatic breast cancer. Meanwhile, participants in the Attention Control arm will first receive a home/work organization intervention before transitioning to the lifestyle program. ^{1 2 4 6 7}

Who Is on the Research Team?

Melinda Stolley, PhD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adult women with metastatic breast cancer who don't follow ACS nutrition or physical activity guidelines, have a mobile phone, and permission from their oncologist to participate. They must be clinically stable even with treated brain metastases, not losing weight unintentionally, no new symptoms or worsening condition in the past month, and expected to live more than 6 months.

Inclusion Criteria

You have a mobile phone.

I have brain metastases but am stable after treatment.

My breast cancer has spread to other parts of my body.

Exclusion Criteria

You do not fit the requirements mentioned earlier.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

Participants receive a 16-week lifestyle intervention promoting nutritional and physical activity changes, including lifestyle coaching, exercise sessions, and cooking classes.

16 weeks

Weekly sessions (in-person or virtual), twice weekly text messages

Attention Control

Participants receive a home/work organization intervention with weekly topics, virtual or phone calls, and text messages.

16 weeks

Weekly virtual or phone calls

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with data collection continuing up to 8 months.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Lifestyle Intervention

Trial Overview

The study tests a lifestyle program focusing on diet and exercise patterns against an attention control group. It aims to understand how these factors affect body composition, blood markers, and quality of life in women with metastatic breast cancer across two cities.

How Is the Trial Designed?

Group I: Immediate Intervention Experimental Treatment 1 Intervention

The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes: 1\) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating.

Group II: Attention Control Experimental Treatment 1 Intervention

The attention control participants will receive a home/work organization intervention: * Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter. * Virtual or weekly phone calls- with a home organization coach with standard prompts. * Text messages supporting home/work organization. Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Loyola University Chicago

Collaborator

Trials

23

Recruited

13,100+

Published Research Related to This Trial

Palliative cancer patients value participation in lifestyle interventions, which can help them adopt healthier habits, take a more active role in their care, and boost their confidence while undergoing chemotherapy.

However, some participants experienced feelings of guilt for not meeting their lifestyle goals, highlighting the need for careful organization of these interventions to avoid adding stress to patients already coping with serious illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Cancer Patients' Experiences of Participating in a Lifestyle Intervention Study While Receiving Chemotherapy. Mikkelsen, HE., Brovold, KV., Berntsen, S., et al.[2017]

A study of 25 women with metastatic breast cancer revealed that many participants had significant nutrition-related symptoms and unhealthy lifestyle habits, including being overweight or obese and having low levels of physical activity.

Despite these challenges, the women reported higher emotional well-being compared to normative samples, indicating a potential area for targeted lifestyle interventions to improve quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Diet, Physical Activity, and Quality of Life in Females with Metastatic Breast Cancer: A Pilot Study to Support Future Intervention. Sheean, P., Kabir, C., Rao, R., et al.[2018]

A pilot study involving 40 women undergoing chemotherapy for breast cancer showed that a weight control program combining a low-fat, high fruit-vegetable diet and moderate physical activity is feasible and well-received, with 75% of participants completing the 12-month study.

The intervention led to significant improvements in fruit and vegetable intake, physical activity, and breast cancer-specific well-being, while participants in the intervention group experienced a decrease in body fat compared to those receiving only written materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Djuric, Z., Ellsworth, JS., Weldon, AL., et al.[2021]

Excess body fat and inactivity are linked to a higher risk of developing breast cancer and poorer outcomes for those diagnosed with early-stage breast cancer, highlighting the importance of lifestyle factors in cancer risk.

Ongoing clinical trials are exploring how weight management and physical activity after a breast cancer diagnosis can potentially reduce the risk of recurrence, while also providing additional health benefits like improved metabolism and reduced risk of other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. Ligibel, JA., Basen-Engquist, K., Bea, JW.[2019]

The CompLife trial, involving 55 women with stage III breast cancer, demonstrated that a comprehensive lifestyle change intervention focusing on diet, exercise, and mind-body practices is feasible and well-received, with high adherence rates (95% for in-person sessions and 88% for video counseling).

Qualitative feedback from participants highlighted the positive impact of the intervention on their lifestyle and well-being, particularly emphasizing the benefits of the mind-body component and social support, suggesting potential for improved disease-free survival and overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience. Arun, B., Austin, T., Babiera, GV., et al.[2018]

The Every Day Counts intervention for women with metastatic breast cancer showed high feasibility and adherence, with participants attending 86% of sessions and reporting significant improvements in quality of life and physical activity over 12 weeks.

The intervention was safe, with no reported injuries, and led to a reduction in visceral fat, suggesting potential benefits for managing health in women with metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer. Sheean, P., Matthews, L., Visotcky, A., et al.[2022]

A 12-month individualized lifestyle intervention for 100 cancer patients undergoing chemotherapy led to significant improvements in healthy dietary habits (37% increase) and reduced distress (94% decrease), indicating the intervention's efficacy in enhancing quality of life during treatment.

Completers of the program were generally younger, more physically active, and had healthier lifestyle choices compared to dropouts, suggesting that demographic and lifestyle factors may influence the success of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle changes in cancer patients undergoing curative or palliative chemotherapy: is it feasible? Vassbakk-Brovold, K., Berntsen, S., Fegran, L., et al.[2018]

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Lifestyle Intervention for Metastatic Breast Cancer (EDC Trial)

This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients.

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