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

May 6, 2013
September 25, 2014
May 2014
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01849978 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Enhancing Exercise in Breast Cancer Survivors
Enhancing Exercise in Breast Cancer Survivors

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Breast Cancer
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
81
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Karen Bodie Hawkins, BA 919-684-4076 karen.hawkins@duke.edu
United States
 
NCT01849978
Pro00044422
No
Duke University
Duke University
Not Provided
Principal Investigator: Isaac Lipkus, PhD Duke University School of Nursing
Duke University
September 2014

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