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

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Medical College of Wisconsin
Study ID
NCT03824145
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lifestyle Intervention — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Nov 1, 2022
Status verified
Apr 2025
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Intervention adherence [ Time Frame: 4 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Loyola UniversityMaywoodIllinois60153
Patricia Sheean, PhD
[email protected]
708-216-0344
Paula O'Connor, MD
[email protected]
708-216-4964
Patricia Sheean, PhD (SUB_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Kathleen O'Connell, MSW
[email protected]
414-955-2114

Find similar trials in Maywood, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Loyola University· Maywood, ILMedical College of Wisconsin· Milwaukee, WI

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