NCT01113554

Brief Summary

RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors. PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

April 28, 2010

Last Update Submit

July 2, 2018

Conditions

Stage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (7)

  • Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program

    Approximately 24 months

  • BMI

    6 months

  • Muscular strength

    6 months

  • Range of motion

    6 months

  • Quality of life

    6 months

  • Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate

    Approximately 24 months

  • Proportion of women who complete the study and the average number of weeks of participation

    Approximately 24 months

Study Arms (1)

Arm I

EXPERIMENTAL

Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.

Other: questionnaire administrationBehavioral: exercise interventionProcedure: quality-of-life assessmentOther: survey administrationProcedure: management of therapy complicationsProcedure: psychosocial assessment and care

Interventions

questionnaire administrationOTHER
Arm I
exercise interventionBEHAVIORAL
Arm I
quality-of-life assessmentPROCEDURE
Also known as: quality of life assessment
Arm I
survey administrationOTHER
Arm I
management of therapy complicationsPROCEDURE
Also known as: complications of therapy, management of
Arm I
psychosocial assessment and carePROCEDURE
Also known as: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies, psychosocial support
Arm I

Eligibility Criteria

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

You may qualify if:

  • First occurrence of breast cancer
  • BMI \>= 25
  • Recently completed treatment(chemotherapy/radiation) for breast cancer (=\< 8 weeks), but can be receiving adjuvant hormonal therapy
  • Willing to comply with study visits, as outlined in the protocol
  • Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius
  • Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Unstable angina
  • Cardiac conduction disturbances
  • Plans to move from the study area
  • Dementia that is medically documented or suspected
  • Advanced arterial disease causing ischemia of any limb
  • Physical immobility
  • Homebound for medical reasons
  • Dependent on wheelchair for mobility
  • Chronic disease which significantly reduces 4-year survival
  • Recurrent breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mara Vitolins

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

April 30, 2010

Study Start

June 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)