Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
88

Summary

Conditions
Invasive Breast Carcinoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors. SECONDARY OBJECTIVE: I. To assess the adherence rate of each of the three 12-week intervention programs by breast cancer survivors in a rando...

PRIMARY OBJECTIVE: I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors. SECONDARY OBJECTIVE: I. To assess the adherence rate of each of the three 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm. EXPLORATORY OBJECTIVES: I. To determine how cardiovascular fitness, body composition, behavior change, biomarkers of mitochondrial function, quality of life (QoL), symptoms of autonomic regulation, cognitive function, and biomarkers of adrenergic stress, inflammation, and immunosuppression are affected by a 12-week physical activity program completed by breast cancer survivors. II. To compare differences in these outcomes among breast cancer survivors who complete a home-based walking program, a home-based Zumba program in either a video game format or a workout DVD (or streamed content) format, a supervised high intensity interval training program, and a wait-list control group. OUTLINE: Participants are randomized into 1 of 4 arms. ARM I: Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and walk 10000 steps per day over 12 weeks in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also undergo resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands. ARM II: Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants undergo resistance training as in Arm I. ARM III: Participants wear Fitbit and attend supervised High Intensity Interval Training (HIIT) exercise sessions 3 days per week over 12 weeks. Participants undergo resistance training as in Arm I. ARM IV: Participants wear Fitbit and continue their usual physical activity over 12 weeks. After completion of study intervention, participants are followed up at 2 weeks and 1 month.

Tracking Information

NCT #
NCT03679559
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Tracey L O'Connor Roswell Park Cancer Institute