NCT00929617

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

7.8 years

First QC Date

June 26, 2009

Last Update Submit

October 13, 2021

Conditions

Breast Cancer

Keywords

breast cancerphysical activityexercisequality of lifedoubly labeled water

Outcome Measures

Primary Outcomes (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).

    baseline to 3 months

  • 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).

    3 mos to 6 months

  • 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).

    6 months to 12 months

Secondary Outcomes (3)

  • change in treadmill fitness

    baseline, 3 months, 6 months, 12 months

  • change in waist-to-hip ratio

    baseline, 3 months, 6 months, 12 months

  • change in 3-day dietary intake

    baseline, 3 months, 6 months, 12 months

Other Outcomes (1)

  • Energy expenditure (doubly labeled water)

    baseline, 3 months, and 6 months

Study Arms (2)

1: exercise with 2 counseling types

EXPERIMENTAL

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

Behavioral: Experimental 1: exercise with 2 counseling types

2. Usual Care - written materials

OTHER

Patients will receive written materials about exercise for cancer survivors

Other: Usual Care - written materials

Interventions

Experimental 1: exercise with 2 counseling typesBEHAVIORAL

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

1: exercise with 2 counseling types
Usual Care - written materialsOTHER

Patients will receive written materials about exercise for cancer survivors

2. Usual Care - written materials

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Illinois

Champaign, Illinois, 61801, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (15)

  • 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.

    PMID: 19383889BACKGROUND

  • 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.

    PMID: 19276838BACKGROUND

  • 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.

    PMID: 19241491BACKGROUND

  • 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.

    PMID: 18820344BACKGROUND

  • 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.

    PMID: 18442339BACKGROUND

  • 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.

    PMID: 21558582BACKGROUND

  • 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.

    PMID: 21983625BACKGROUND

  • 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.

    PMID: 25417174RESULT

  • 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.

    PMID: 40420153DERIVED

  • 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.

    PMID: 37120460DERIVED

  • 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.

    PMID: 36723801DERIVED

  • 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.

    PMID: 36711885DERIVED

  • 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.

    PMID: 36526826DERIVED

  • 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.

    PMID: 29759953DERIVED

  • 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.

    PMID: 27752993DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Laura Q. Rogers, MD, MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 29, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

US(3)