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Breast CancerBEATNCT00929617

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

A study testing Experimental 1: exercise with 2 counseling types in people with Breast Cancer, run by University of Alabama at Birmingham at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Experimental 1: exercise with 2 counseling types
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
3 sitesUnited States
Study dates
Jun 2009to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Illinois

    Champaign, Illinois, 61801

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

Other trials in United States

About this study

Official title: Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)

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.

Read the detailed description

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
Breast Cancer
Being tested
Experimental 1: exercise with 2 counseling types, Usual Care - written materials
Keywords
breast cancer, physical activity, exercise, quality of life, doubly labeled water
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental 1: exercise with 2 counseling typesBehavioural

    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

  • Usual Care - written materialsOther

    Patients will receive written materials about exercise for cancer survivors

Study groups in NCT00929617
Study groupRoleWhat they receive
1: exercise with 2 counseling typesExperimentalPatients 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
Receives: Behavioral: Experimental 1: exercise with 2 counseling types
2. Usual Care - written materialsOtherPatients will receive written materials about exercise for cancer survivors
Receives: Other: Usual Care - written materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in physical activity

    Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).

    Measured: baseline to 3 months

  2. change in physical activity

    Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).

    Measured: 3 mos to 6 months

  3. change in physical activity

    Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).

    Measured: 6 months to 12 months

Secondary outcomes (3)
  1. change in treadmill fitness

    Treadmill fitness will be measured by sub-maximal fitness test. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).

    Measured: baseline, 3 months, 6 months, 12 months

  2. change in waist-to-hip ratio

    Waist-to-hip ratio will be measured with a tape measure. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).

    Measured: baseline, 3 months, 6 months, 12 months

  3. change in 3-day dietary intake

    3-day dietary intake will be measured by questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).

    Measured: baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00929617
Sponsor's protocol ID
ROG-SCCI 09-003-2
Other IDs
3R01CA136859-02S1, U01CA136859
Acronym
BEAT
Status last verified
Oct 2021
First submitted
26 Jun 2009
Last updated
21 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.

    PubMed 19383889
  • Rogers LQ, Hopkins-Price P, Vicari S, Pamenter R, Courneya KS, Markwell S, Verhulst S, Hoelzer K, Naritoku C, Jones L, Dunnington G, Lanzotti V, Wynstra J, Shah L, Edson B, Graff A, Lowy M. A randomized trial to increase physical activity in breast cancer survivors. Med Sci Sports Exerc. 2009 Apr;41(4):935-46. doi: 10.1249/MSS.0b013e31818e0e1b.

    PubMed 19276838
  • 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.

    PubMed 19241491
  • 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.

    PubMed 18820344
  • 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.

    PubMed 18442339
  • 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.

    PubMed 21558582
  • Rogers LQ, McAuley E, Anton PM, Courneya KS, Vicari S, Hopkins-Price P, Verhulst S, Mocharnuk R, Hoelzer K. Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. Contemp Clin Trials. 2012 Jan;33(1):124-37. doi: 10.1016/j.cct.2011.09.004. Epub 2011 Sep 29.

    PubMed 21983625
  • Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Vicari SK, Robbs RS, Mocharnuk R, McAuley E. Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial. Breast Cancer Res Treat. 2015 Jan;149(1):109-19. doi: 10.1007/s10549-014-3216-z. Epub 2014 Nov 23.

    PubMed 25417174
  • Rogers LQ, Midthune D, Dodd K, Bowles H, McAuley E, Courneya KS, Barrett B, Razis S, Hunter GR, Carter SJ, Carroll RJ, Kipnis V. Accelerometer measurement error in a randomized physical activity intervention trial in breast cancer survivors was nondifferential but attenuated the intervention effect. Int J Behav Nutr Phys Act. 2025 May 26;22(1):59. doi: 10.1186/s12966-025-01760-5.

    PubMed 40420153
  • Schleicher E, McAuley E, Courneya KS, Anton P, Ehlers DK, Phillips SM, Brown NI, Oster RA, Pekmezi D, Rogers LQ. Breast cancer survivors' exercise preferences change during an exercise intervention are associated with post-intervention physical activity. J Cancer Surviv. 2024 Oct;18(5):1453-1463. doi: 10.1007/s11764-023-01389-y. Epub 2023 Apr 29.

    PubMed 37120460
  • 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.

    PubMed 36723801
  • Schleicher E, McAuley E, Courneya KS, Anton P, Ehlers DK, Phillips SM, Brown NI, Oster RA, Pekmezi D, Rogers LQ. Breast Cancer Survivors' Exercise Preferences Change During an Exercise Intervention and are associated with Post-Intervention Physical Activity. Res Sq [Preprint]. 2023 Jan 20:rs.3.rs-2488848. doi: 10.21203/rs.3.rs-2488848/v1.

    PubMed 36711885
  • Schleicher E, McAuley E, Courneya KS, Anton P, Ehlers DK, Phillips SM, Oster RA, Pekmezi D, Rogers LQ. Moderators of physical activity and quality of life response to a physical activity intervention for breast cancer survivors. Support Care Cancer. 2022 Dec 17;31(1):53. doi: 10.1007/s00520-022-07477-6.

    PubMed 36526826
  • 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.

    PubMed 29759953
  • Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Robbs RS, Vicari SK, McAuley E. Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Ann Behav Med. 2017 Apr;51(2):321-326. doi: 10.1007/s12160-016-9840-6.

    PubMed 27752993

Questions about this trial

What is this clinical trial studying?

A study testing Experimental 1: exercise with 2 counseling types in people with Breast Cancer, run by University of Alabama at Birmingham at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in physical activity (time frame: baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929617, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.

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