NCT01173861

Brief Summary

Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors. Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

May 25, 2010

Last Update Submit

July 12, 2012

Conditions

Breast CancerQuality of LifePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors.

    The primary outcome is to examine the effectiveness of a cancer center based physical activity intervention on increasing physical activity as measured by step counts on a pedometer.

    8 weeks

Secondary Outcomes (1)

  • Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors.

    8 weeks

Study Arms (2)

Physical activity counseling

EXPERIMENTAL

Group receives face-to-face physical activity counseling.

Behavioral: Physical activity counseling

Manual

ACTIVE COMPARATOR

Group receives physical activity manual.

Behavioral: Physical activity counseling

Interventions

Physical activity counselingBEHAVIORAL

20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions.

ManualPhysical activity counseling

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of breast cancer within the last 5 years
  • Over the age of 18 years
  • female

You may not qualify if:

  • Non-ambulatory
  • Poor cognitive function
  • Contraindications for exercise as determined by the PAR-Q

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leo Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Kristina H Karvinen, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2010

First Posted

August 2, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

US(1)