Breast Cancer
Conditions
Brief summary
This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing \[MI\] and tailored newsletters) on obese (body mass index \[BMI\] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.
Detailed description
The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.
Interventions
BEHAVIORALDietary Intervention
Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change.
BEHAVIORALDietary Control
Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.
Sponsors
Susan G. Komen Breast Cancer Foundation
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Females 18 years or older * Primary diagnosis of breast cancer * Fluency in English * B.M.I. \>= 30 * Available for follow-up for 12 months
Exclusion criteria
* Clinical evidence of metastatic disease * Not diagnosed with primary breast cancer * Lack fluency in English * B.M.I. \< 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieve USDA-recommended dietary intake based on five major food groups | 12 months | The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score (yes vs. no) describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values. |
| Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up | 12 months | We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values. |
| Comparison of Interleukin (IL) pro-inflammatory biomarkers | 12 months | We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values. |
| Comparison of Interleukin (IL) anti-inflammatory biomarkers | 12 months | We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values. |
| Comparison of C-Reactive Protein (CRP) | 12 months | We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values. |
| Comparison of Tumor Necrosis Factor-alpha (TNF-alpha) | 12 months | We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values. |
Countries
United States
Outcome results
None listed