Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT03824145

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lifestyle Intervention

Attention Control

Study Details

Brief summary:

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).

Conditions

Metastatic Breast Cancer

Study ID

NCT03824145

Start date

Nov 1, 2022

Status verified date

Apr, 2025

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Immediate 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.

other: Attention Control

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.

Interventions

Lifestyle Intervention

The lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes.

Attention Control

The attention control participants will receive a home/work organization intervention:

Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.

Primary outcome measure

  • Intervention adherence [ Time Frame: 4 months ]
  • Intervention retention [ Time Frame: 4 months ]
  • Intervention retention [ Time Frame: 8 months ]
  • Change in Quality of Life [ Time Frame: Change from baseline to 4 months ]
  • Change in Quality of Life [ Time Frame: change from baseline to 8 months ]
  • Body composition [ Time Frame: change from baseline to 4 months ]
  • Body composition [ Time Frame: change from baseline to 8 months ]

Central Contacts and Locations

Central contacts

Kathleen OConnell, MSW

414-955-2114kaoconnell@mcw.edu

Locations

Loyola University

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Patricia Sheean, PhD

708-216-0344psheean1@luc.edu

Paula O'Connor, MD

708-216-4964poconnor1@luc.edu

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kathleen O'Connell, MSW

414-955-2114kaoconnell@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Apr 27, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-04-27.