Exercise Post-Diagnosis of Breast Cancer

University of Hawaii

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04013568

Fukui-2019-1

Details and patient eligibility

About

The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.

Full description

The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.

Enrollment: 165 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
• Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
• Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
• Participant must be able to lie flat on their back for up to 10 minutes
• Participant must be able to stand without aid for at least 2 minutes

Exclusion criteria

• Participant with breast cancer recurrence
• Metastatic breast cancer
• Uncontrolled psychiatric disorder that can affect self-assessment
• Pregnant patient
• Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Group 1 - Agree to Exercise Program

Active Comparator group

Description:

12-week exercise program

Treatment:

Other: Exercise

Group 2 - Declines Exercise Program

No Intervention group

Description:

Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions