Enhancing Exercise in Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01849978
First received: May 6, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

This study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.


Condition Intervention
Breast Cancer
Behavioral: Newsletter about physical activity and breast cancer survivors
Behavioral: Changing your habits brochure
Behavioral: Tips for making exercise enjoyable and personally-valued
Behavioral: Testimonials from breast cancer survivors

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Enhancing Exercise in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • change in number of minutes of moderate to strenuous physical activity [ Time Frame: baseline, 1 month and 3 months ] [ Designated as safety issue: No ]
    participants will self-report minutes of physical activity at baseline, 1 month, and 3 months after receiving intervention materials.


Secondary Outcome Measures:
  • changes in joy and satisfaction with physical activity [ Time Frame: baseline, 1 month, and 3 months ] [ Designated as safety issue: No ]
    participants will self-report via questionnaire their joy and satisfaction with their average physical activity level.


Estimated Enrollment: 81
Study Start Date: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control arm
Participants in this arm will receive the newsletter about their reported minutes of physical activity and the benefits of physical activity specific to breast cancer survivors, and the brochure "Changing your habits," developed by the NIH.
Behavioral: Newsletter about physical activity and breast cancer survivors
Both groups will receive a newsletter that covers: 1) the recommendation to pursue at least 150 mins/week of moderate to strenuous intensity PA, 2) the benefits of PA specific to breast cancer survivors (e.g., reducing in death and breast cancer recurrence), and 3) their total minutes of moderate to strenuous intensity PA and how this compares to the recommendation.
Behavioral: Changing your habits brochure
Both groups will receive the brochure titled "Changing Your Habits: Steps to Better Health", developed by the NIH, that describes, based a person's stage of change, the benefits of PA, how to overcome common barriers to PA, and if ready, how to plan for PA.
Active Comparator: Habit Formation Arm
Participants in this arm will receive all of the intervention materials.
Behavioral: Newsletter about physical activity and breast cancer survivors
Both groups will receive a newsletter that covers: 1) the recommendation to pursue at least 150 mins/week of moderate to strenuous intensity PA, 2) the benefits of PA specific to breast cancer survivors (e.g., reducing in death and breast cancer recurrence), and 3) their total minutes of moderate to strenuous intensity PA and how this compares to the recommendation.
Behavioral: Changing your habits brochure
Both groups will receive the brochure titled "Changing Your Habits: Steps to Better Health", developed by the NIH, that describes, based a person's stage of change, the benefits of PA, how to overcome common barriers to PA, and if ready, how to plan for PA.
Behavioral: Tips for making exercise enjoyable and personally-valued
Participants will get a list of potentially enjoyable activities and a space to list other activities after they consider aspects that can make events fun/interesting.13 Aspects to consider include: location (indoors vs. outdoors, the latter which may appeal to some), hobbies that can involve PA (e.g., sports, dancing), whether the activity is made more enjoyable by having it performed by oneself or with others (e.g., team activities vs. individual activities); what valued outcomes may be achieved (e.g., sense of competence, pride, better health, body image), accompanying activities that are pleasant (e.g., listening to music), etc.
Behavioral: Testimonials from breast cancer survivors
Participants will get two to three testimonials of actual breast cancer survivors. These testimonials will include story-like details of what these survivors find enjoyable about exercising and what they have done to make exercise enjoyable.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • no health restrictions on performing moderate to strenuous physical activity
  • must be 18 years or older and able to give legal consent

Exclusion Criteria:

  • may not be participating in another research study regarding exercise
  • restrictions on performing physical activity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849978

Contacts
Contact: Karen Bodie Hawkins, BA 919-684-4076 karen.hawkins@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27701
Contact: Karen B Hawkins, BA    919-684-4076    karen.hawkins@duke.edu   
Principal Investigator: Isaac Lipkus, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Isaac Lipkus, PhD Duke University School of Nursing
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01849978     History of Changes
Other Study ID Numbers: Pro00044422
Study First Received: May 6, 2013
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
breast cancer
survivor
exercise
physical activity
strenuous exercise
moderate exercise
enjoyable exercise
enjoy exercise
breast cancer survivor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014