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

The Ohio State University

Status: Completed

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

Treatments: Other: Nutritional Assessment; Other: Questionnaire Administration; Other: Aerobic Exercise; Other: Resistance Training; Other: Quality-of-Life Assessment; Other: Exercise Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04454086

OSU-17122 (Other Identifier)

NCI-2019-00570 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

Supportive care (exercise program, counseling)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Resistance Training

Other: Aerobic Exercise

Other: Nutritional Assessment

Other: Exercise Counseling

Other: Questionnaire Administration