Physical Activity Promotion in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Physical Activity Promotion in Breast Cancer Survivors: A Population Based Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221221
• Other study ID #: ACTION
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: May 2, 2007
• Start date: July 2005
• Est. completion date: March 2006

Study information

• Verified date: May 2007
• Source: University of Alberta, Physical Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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 in the three intervention groups will report a greater positive change in physical activity than participants in the exercise recommendation only group. Furthermore, we expect 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. Our sample size was determined by a power calculation. Based on the literature, we believe that an increase of 2,000 steps per day is a meaningful change that will result in health benefits for breast cancer survivors. We estimate a standard deviation of about 4,000 steps per day. Therefore, to detect a medium standardized effect (d = .50) with a power of .80 and a two-tailed alpha <.05, we need 63 participants per group. To account for a possible 15% loss to follow up, we will randomize 75 participants to each group. Our printed materials will be developed based on the tenets of the theory of planned behavior and will include activities designed to enhance instrumental and affective attitudes, injunctive and descriptive norms, and self-efficacy and perceptions of control. These materials will be developed based on our previous research identifying the key beliefs that should be targeted in a theory of planned behavior-based intervention.

Our procedure will be to identify and screen potential participants for eligibility through the Alberta Cancer Registry. After obtaining written informed consent from the individual’s treating oncologist, all eligible participants will be sent a letter of invitation to participate in the study. Interested participants will complete a baseline questionnaire that will include measures of physical activity (the Godin Leisure-Time Exercise Questionnaire), QoL (Functional Assessment of Cancer Therapy-Breast and Anemia), and social cognitive variables from the theory of planned behavior (based on the guidelines from Ajzen and our previous research). Participants will also wear a pedometer for a 7-day monitoring period to obtain baseline steps. Participants will then be randomized to one of four groups. Depending on randomization, the participants will then receive the appropriate materials. All groups will be recommended to accumulate at least 30 minutes of moderate intensity physical activity at least five days per week which would result in about 15,000 steps per week (or 2,000 steps per day). At the end of the 12-week intervention period, all participants will complete the same post intervention questionnaire and undergo another 7-day monitoring period to obtain step values. Participants will be contacted at 6 months for follow-up and complete the same questionnaire for a final time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Pedometer

• Exercise guidebook

Locations

Country	Name	City	State
Canada	University of Alberta, Behavioral Medicine Laboratory	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta, Physical Education

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise behavior
Secondary	Quality of life
Secondary	Social cognitive determinants of exercise