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Enhancing Exercise in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01849978
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 9, 2013
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
change in number of minutes of moderate to strenuous physical activity [ Time Frame: baseline, 1 month and 3 months ]
participants will self-report minutes of physical activity at baseline, 1 month, and 3 months after receiving intervention materials.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01849978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
changes in joy and satisfaction with physical activity [ Time Frame: baseline, 1 month, and 3 months ]
participants will self-report via questionnaire their joy and satisfaction with their average physical activity level.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Exercise in Breast Cancer Survivors
Official Title  ICMJE Enhancing Exercise in Breast Cancer Survivors
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Newsletter about physical activity and breast cancer survivors
    • Behavioral: Changing your habits brochure
  • Active Comparator: Habit Formation Arm
    Participants in this arm will receive all of the intervention materials.
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 6, 2013)
81
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849978
Other Study ID Numbers  ICMJE Pro00044422
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isaac Lipkus, PhD Duke University School of Nursing
PRS Account Duke University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP