NCT00721565

Brief Summary

"Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

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

April 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

July 22, 2008

Last Update Submit

May 9, 2015

Conditions

Keywords

Breast CancerExerciseSocial Cognitive TheoryAdherenceSymptomsBody Composition

Outcome Measures

Primary Outcomes (1)

  • change in physical activity

    6 months

Secondary Outcomes (2)

  • social cognitive and biopsychosocial outcomes

    3 months

  • social cognitive and biopsychosocial outcomes

    6 months

Study Arms (2)

1

EXPERIMENTAL

behavior change intervention

Behavioral: Exercise Behavior Change

2

NO INTERVENTION

written materials

Interventions

attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist

1

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 Stage I, II, or IIIA breast cancer who are currently taking aromatase inhibitors or selective estrogen receptor modulators for the next 8 months.
  • English speaking
  • Medical clearance for participation provided by primary care physicians
  • If the patient has undergone a surgical procedure, must be at least 6 weeks post-procedure

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
  • Engaged in \>/= 60 minutes of vigorous physical activity or \>/= 150 minutes of moderate plus vigorous physical activity per week during the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (5)

  • 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, Vicari S, Courneya KS. Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Cancer Nurs. 2010 Nov-Dec;33(6):E10-7. doi: 10.1097/NCC.0b013e3181db699d.

    PMID: 20562618BACKGROUND
  • 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
  • Ehlers DK, Rogers LQ, Courneya KS, Robbs RS, McAuley E. Effects of BEAT Cancer randomized physical activity trial on subjective memory impairments in breast cancer survivors. Psychooncology. 2018 Feb;27(2):687-690. doi: 10.1002/pon.4438. Epub 2017 May 11. No abstract available.

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

    Southern Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

April 1, 2006

Primary Completion

February 1, 2008

Study Completion

August 1, 2008

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations