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Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors

Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors

Recruiting
30-75 years
Female
Phase N/A

Overview

This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.

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 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.

Eligibility

Inclusion Criteria:

  • Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
  • Overweight/obese (body mass index [BMI] > 25).
  • Ability to understand and the willingness to sign a written informed consent.
  • Willing and physically able to participate in physical activity.
  • Obtain physician consent via primary care physician and/or treating oncologist.

Exclusion Criteria:

  • > 60 months post breast cancer therapy.
  • Contraindications to exercise.
  • Diagnosis of cancer other than breast that is receiving active treatment.
  • Currently receiving chemotherapy/radiation.
  • Musculoskeletal/neurological disorder inhibiting them from safe exercise.
  • Pregnant or nursing women.
  • Unable to give informed consent.

Study details
    Overweight
    Obesity
    Obesity
    Anatomic Stage I Breast Cancer AJCC v8
    Anatomic Stage IA Breast Cancer AJCC v8
    Anatomic Stage IB Breast Cancer AJCC v8
    Anatomic Stage II Breast Cancer AJCC v8
    Anatomic Stage IIA Breast Cancer AJCC v8
    Anatomic Stage IIB Breast Cancer AJCC v8
    Anatomic Stage III Breast Cancer AJCC v8
    Anatomic Stage IIIA Breast Cancer AJCC v8
    Anatomic Stage IIIB Breast Cancer AJCC v8
    Anatomic Stage IIIC Breast Cancer AJCC v8
    Prognostic Stage I Breast Cancer AJCC v8
    Prognostic Stage IA Breast Cancer AJCC v8
    Prognostic Stage IB Breast Cancer AJCC v8
    Prognostic Stage II 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
    Prognostic Stage IIIB Breast Cancer AJCC v8
    Prognostic Stage IIIC Breast Cancer AJCC v8
    Cancer Survivor

NCT04454086

Ohio State University Comprehensive Cancer Center

16 February 2024

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