NCT00221221

Brief Summary

Over 30 studies have shown that exercise can improve physical fitness, reduce fatigue, increase functioning, and enhance overall quality of life (QoL) in breast cancer survivors both during and after treatments. Research has also shown, however, that breast cancer survivors experience a significant reduction in physical activity during treatments that is not recovered even years after treatments are completed. The objectives of this study are to examine the effects of two behavior change interventions (a step pedometer and printed materials) on physical activity, social cognitive variables, and QoL in a population-based sample of breast cancer survivors. Approximately 300 breast cancer survivors living in Northern Alberta will be randomized to one of four groups: (1) an exercise recommendation only group (viewed as the current standard of care), (2) an exercise recommendation plus pedometer group, (3) an exercise recommendation plus printed materials group, and (4) an exercise recommendation plus pedometer and printed materials group. Our primary hypothesis is that participants receiving the combined pedometer and printed materials intervention will report the greatest change in physical activity. Our secondary hypotheses are that these interventions will also result in improved QoL and more positive social cognitive beliefs about exercise in breast cancer survivors. Given the geographic dispersion of our population, finding practical and sustainable interventions that employ distance medicine-based approaches may be ideal for promoting healthy activity patterns in breast cancer survivors in Northern Alberta.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2 breast-cancer

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

First QC Date

September 13, 2005

Last Update Submit

November 4, 2024

Conditions

Keywords

breast cancer survivorsphysical activityhealth promotion

Outcome Measures

Primary Outcomes (1)

  • Exercise behavior

Secondary Outcomes (2)

  • Quality of life

  • Social cognitive determinants of exercise

Interventions

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed breast cancer.
  • mentally competent.
  • physician approval to participate in the study.
  • free from chronic medical and orthopaedic conditions.
  • no current or planned pregnancy.
  • ability to read and understand English.
  • must be in the post treatment phase of their cancer trajectory.
  • willing to accept random assignment.
  • not currently participating in another QoL intervention.
  • no known or active metastatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta, Behavioral Medicine Laboratory

Edmonton, Alberta, T6G 2H9, Canada

Location

Related Publications (1)

  • Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007 Jun 10;25(17):2352-9. doi: 10.1200/JCO.2006.07.9988.

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Jeffrey KH Vallance, MA

    University of Alberta

    PRINCIPAL INVESTIGATOR
  • Kerry S Courneya, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Study Completion

March 1, 2006

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations