Trials / Completed

CompletedNCT04454086

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

Healthy New Albany: Breast Cancer Project

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 21 (actual)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: Female
Age: 30 Years – 75 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
OTHER	Aerobic Exercise	Undergo aerobic exercise
OTHER	Exercise Counseling	Receive behavioral activity counseling
OTHER	Nutritional Assessment	Receive nutritional counseling
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Resistance Training	Undergo resistance exercises

Timeline

Start date: 2019-03-06
Primary completion: 2021-07-27
Completion: 2021-07-27
First posted: 2020-07-01
Last updated: 2024-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04454086. Inclusion in this directory is not an endorsement.