Lifestyle Intervention for Metastatic Breast Cancer

(EDC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Melinda Stolley, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-female, No MBC, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this 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. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88).

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.

What data supports the effectiveness of the treatment Lifestyle Intervention for Metastatic Breast Cancer?

Research suggests that lifestyle interventions, including diet and physical activity, can improve quality of life and reduce symptom burden in women with metastatic breast cancer. These interventions may also offer additional health benefits, such as better physical functioning and reduced risk of other diseases like diabetes and heart disease.

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Is the lifestyle intervention for metastatic breast cancer safe for humans?

Research indicates that lifestyle interventions, including diet and physical activity, are generally safe for women with metastatic breast cancer. These interventions have shown benefits in quality of life and physical well-being without significant safety concerns.

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How is the Lifestyle Intervention treatment for metastatic breast cancer different from other treatments?

The Lifestyle Intervention treatment for metastatic breast cancer is unique because it focuses on comprehensive lifestyle changes, including diet and physical activity, rather than traditional medical treatments. This approach is novel as it aims to improve quality of life and potentially influence disease outcomes by addressing multiple lifestyle factors, which have not been extensively tested in this patient group before.

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Eligibility Criteria

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.

I am a woman aged 18 or older.

Exclusion Criteria

You do not fit the requirements mentioned earlier.

Trial Timeline

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

Participant Groups

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.

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Loyola University Maywood, IL

Medical College of Wisconsin Milwaukee, WI

Who Is Running the Clinical Trial?

Medical College of Wisconsin Lead Sponsor

Loyola University Chicago Collaborator

References

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

Palliative Cancer Patients' Experiences of Participating in a Lifestyle Intervention Study While Receiving Chemotherapy. [2017] Lifestyle interventions have promise in terms of their potential health benefits and as an empowerment tool for cancer patients. Nevertheless, documentation of palliative cancer patients experiences of participating in lifestyle interventions remains poor.

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

Weight Management and Physical Activity for Breast Cancer Prevention and Control. [2019] Observational evidence has consistently linked excess adiposity and inactivity to increased breast cancer risk and to poor outcomes in individuals diagnosed with early-stage, potentially curable breast cancer. There is less information from clinical trials testing the effect of weight management or physical activity interventions on breast cancer risk or outcomes, but a number of ongoing trials will test the impact of weight loss and other lifestyle changes after cancer diagnosis on the risk of breast cancer recurrence. Lifestyle changes have additional benefits beyond their potential to decrease primary or secondary breast cancer risk, including improvements in metabolic parameters, reduction in the risk of comorbidities such as diabetes and heart disease, improvement of physical functioning, and mitigation of side effects of cancer therapy. Despite these myriad benefits, implementation of lifestyle interventions in at-risk and survivor populations has been limited to date. This article reviews the evidence linking lifestyle factors to breast cancer risk and outcomes, discusses completed and ongoing randomized trials testing the impact of lifestyle change in primary and secondary breast cancer prevention, and reviews efforts to implement and disseminate lifestyle interventions in at-risk and breast cancer survivor populations.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer. [2022] To explore the feasibility, adherence, safety and potential efficacy of Every Day Counts; a randomized pilot trial designed for women with metastatic breast cancer (MBC) framed by the American Cancer Society nutrition and physical activity (PA) guidelines METHODS: Women with clinically stable MBC were recruited to complete an interview, dual energy X-ray absorptiometry imaging and phlebotomy at baseline and post-intervention. Multidimensional quality of life, symptom burden, lifestyle behaviors (nutrition and PA) and biomarkers of prognosis were procured and quantified. Women were randomized to the immediate intervention or a waitlist control arm. The 12-week intervention included a curriculum binder, lifestyle coaching (in-person and telephone-based sessions) and intervention support (activity monitor, text messaging, cooking classes.) Women in the waitlist control were provided monthly text messaging.

4. United States 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. [2018] Historically, women with metastatic breast cancer are excluded from lifestyle interventions under the assumptions that diet and physical activity will have little impact on their disease trajectory. However, recent treatment advances have led to significant increases in survivorship that pose challenges to this assumption.

5. England pubmed.ncbi.nlm.nih.gov

Lifestyle changes in cancer patients undergoing curative or palliative chemotherapy: is it feasible? [2018] This study aimed to explore the feasibility of an individualized comprehensive lifestyle intervention in cancer patients undergoing curative or palliative chemotherapy.

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

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience. [2018] Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife).

7. Netherlands pubmed.ncbi.nlm.nih.gov

A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. [2021] Weight gain is an important concern that impacts on breast cancer outcomes and general health in survivorship. This randomized, pilot study evaluated whether or not women could comply with a weight control program that is initiated at the beginning of chemotherapy for breast cancer. The program sought to prevent weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity. The intervention was implemented using a telephone counseling approach that blended motivational interviewing with social cognitive theory. A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center. This represents 55% of eligible women referred to the study and indicates that interest in a healthy lifestyle program at the initiation of chemotherapy for breast cancer was high. Subjects who dropped out had significantly lower fruit and vegetable intakes and lower blood carotenoids at baseline than subjects who completed the study. Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention. Mean body fat from dual energy X-ray absorptiometry increased in the written materials arm and decreased in the intervention arm. Of the enrolled women, 75% completed 12 months on study and satisfaction with study participation was high. These data indicate that lifestyle intervention during breast cancer treatment is feasible during treatment with chemotherapy for breast cancer and benefits women in several domains.