Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)

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

COMPLETED

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-03-31

Brief Summary

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The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.

Detailed Description

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Physical activity may improve quality of life, the control of comorbid conditions, and weight management while reducing breast cancer recurrence and mortality among breast cancer survivors. Unfortunately, most breast cancer survivors do not engage in regular physical activity. In fact, breast cancer survivors are often less active after a diagnosis and may not return to pre-diagnosis activity levels. Therefore, we conducted a pilot study, "BEAT Cancer", to test a specifically defined physical activity behavior change intervention to increase physical activity for breast cancer survivors. The pilot study showed significant improvement in both physical activity and health outcomes for the study participants after the intervention. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, such as the participants feeling more confident in their ability to exercise. The positive results enhance our potential for testing mechanisms that encourage physical activity behavior change in breast cancer survivors. The current study is a follow-up to confirm program effectiveness at 3 months and to test sustainability of results at 3-12 months. We propose a multi-center, randomized controlled trial enrolling 356 breast cancer survivors with the following study aims:

1. To compare the effects of the 3-month BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. We hypothesize that, compared with usual care, the intervention will result in a significant increase in physical activity after the intervention that will be maintained up to 12 months after baseline.
2. To better understand the reasons why breast cancer patients change their physical activity behavior, we will compare the effects of the BEAT Cancer physical activity behavior change intervention to usual care on social cognitive factors to see if such changes contribute to physical activity behavior change. We hypothesize that, compared with usual care, the intervention will result in significant improvements in social cognitive factors which lead to changes in physical activity behavior.
3. We also aim to compare the short and longer term health effects of the BEAT Cancer physical activity behavior change intervention when compared with usual care. We hypothesize that, compared with usual care, the intervention will result in significant improvements in fitness, muscle strength, waist-to-hip ratio, quality of life, fatigue, and sleep quality, while reducing joint dysfunction.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: exercise with 2 counseling types

Patients will participate in 12 individual exercise sessions with an exercise specialist; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist

Group Type EXPERIMENTAL

Experimental 1: exercise with 2 counseling types

Intervention Type BEHAVIORAL

Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist

2. Usual Care - written materials

Patients will receive written materials about exercise for cancer survivors

Group Type OTHER

Usual Care - written materials

Intervention Type OTHER

Patients will receive written materials about exercise for cancer survivors

Interventions

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Experimental 1: exercise with 2 counseling types

Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist

Intervention Type BEHAVIORAL

Usual Care - written materials

Patients will receive written materials about exercise for cancer survivors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or IIIA breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. The upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
* If the patient has undergone a surgical procedure, enrollment will be delayed until ≥ 8 weeks post-procedure.
* English speaking.
* Medical clearance for participation provided by primary care physician or oncologist.
* Participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.

Exclusion Criteria

* Diagnosis of dementia or organic brain syndrome.
* Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
* Contraindication to participation in a regular physical activity program.
* Metastatic or recurrent disease.
* Inability to ambulate.
* Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
* Planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Laura Q. Rogers, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Q. Rogers, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Illinois

Champaign, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Countries

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United States

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3R01CA136859-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA136859

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ROG-SCCI 09-003-2

Identifier Type: -

Identifier Source: org_study_id

Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

1: exercise with 2 counseling types

Experimental 1: exercise with 2 counseling types

2. Usual Care - written materials

Usual Care - written materials

Interventions

Experimental 1: exercise with 2 counseling types

Usual Care - written materials

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Cancer Institute (NCI)

National Institutes of Health (NIH)

University of Illinois at Urbana-Champaign

Southern Illinois University

University of Alabama at Birmingham

Responsible Party

Laura Q. Rogers, MD, MPH

Principal Investigators

Laura Q. Rogers, MD, MPH

Locations

University of Alabama at Birmingham

University of Illinois

Southern Illinois University School of Medicine

Countries

References

Rogers LQ, Markwell SJ, Verhulst S, McAuley E, Courneya KS. Rural breast cancer survivors: exercise preferences and their determinants. Psychooncology. 2009 Apr;18(4):412-21. doi: 10.1002/pon.1497.

Rogers LQ, Courneya KS, Verhulst S, Markwell SJ, McAuley E. Factors associated with exercise counseling and program preferences among breast cancer survivors. J Phys Act Health. 2008 Sep;5(5):688-705. doi: 10.1123/jpah.5.5.688.

Rogers LQ, McAuley E, Courneya KS, Verhulst SJ. Correlates of physical activity self-efficacy among breast cancer survivors. Am J Health Behav. 2008 Nov-Dec;32(6):594-603. doi: 10.5555/ajhb.2008.32.6.594.

Rogers LQ, Markwell S, Hopkins-Price P, Vicari S, Courneya KS, Hoelzer K, Verhulst S. Reduced barriers mediated physical activity maintenance among breast cancer survivors. J Sport Exerc Psychol. 2011 Apr;33(2):235-54. doi: 10.1123/jsep.33.2.235.

Rogers LQ, Courneya KS, Oster RA, Anton PM, Phillips S, Ehlers DK, McAuley E. Physical activity intervention benefits persist months post-intervention: randomized trial in breast cancer survivors. J Cancer Surviv. 2023 Dec;17(6):1834-1846. doi: 10.1007/s11764-022-01329-2. Epub 2023 Feb 1.

Ainsworth MC, Pekmezi D, Bowles H, Ehlers D, McAuley E, Courneya KS, Rogers LQ. Acceptability of a Mobile Phone App for Measuring Time Use in Breast Cancer Survivors (Life in a Day): Mixed-Methods Study. JMIR Cancer. 2018 May 14;4(1):e9. doi: 10.2196/cancer.8951.

Related Links

Other Identifiers

3R01CA136859-02S1

U01CA136859

ROG-SCCI 09-003-2