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Exercise Post-Diagnosis of Breast Cancer

NCT ID: NCT04013568

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-28

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Agree to Exercise Program

12-week exercise program

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students

Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes

Group 2 - Declines Exercise Program

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students

Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rehabilitation Hospital of the Pacific

UNKNOWN

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jami Fukui, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii Cancer Research Center

Locations

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University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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Fukui-2019-1

Identifier Type: -

Identifier Source: org_study_id