Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage I Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Overweight
  • Cancer Survivor
  • Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 30 years and 75 years
Gender
Only males

Description

PRIMARY OBJECTIVES: I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors. II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for produc...

PRIMARY OBJECTIVES: I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors. II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors. III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors. OUTLINE: Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2. After completion of study, patients are followed up at 3 and 6 months.

Tracking Information

NCT #
NCT04454086
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brian C Focht, PhD Ohio State University Comprehensive Cancer Center