Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer (EDC)

Medical College of Wisconsin

Status: Enrolling

Conditions: Metastatic Breast Cancer

Treatments: Behavioral: Lifestyle Intervention; Behavioral: Attention Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03824145

27600

Details and patient eligibility

About

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).

Full description

Aims/Objectives

Aim 1. To examine the efficacy of the Every Day Counts intervention in producing significant post-intervention changes in multidimensional QOL in women with MBC.

Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater improvements in multidimensional QOL compared to women randomized to the attention control (n=88).

Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.

Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.

Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention.

Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p) that regulate inflammation and/or Metabolomics will be related to QOL improvements and can identify women more likely to respond to lifestyle changes.

Enrollment: 176 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥ 18 years), female

• Confirmed Metastatic Breast Cancer

• Patients clinically stable with treated brain metastases are eligible

• Written documentation from their oncologist permitting study participation

• Determined to be "clinically stable" by their medical oncologist (i.e., no unintentional weight loss, no new symptoms or change in performance status for the past 4 weeks, no clinical [including laboratory] or radiologic evidence of disease progression, no recent or planned change in anti-neoplastic therapies, no reports of severe pain [≥ Grade 3 per the NCI CTCAE)

• Life expectancy >6 months

  -Written documentation from their oncologist permitting study participation

• Access to a mobile phone

• Understand/speak English fluently.

• Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.

Exclusion criteria

• Does not meet the above criteria.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Intervention

Attention Control

Other group

Description:

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.

Treatment:

Behavioral: Attention Control