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Enhancing Exercise in Breast Cancer Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01849978
First Posted: May 9, 2013
Last Update Posted: January 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  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 ]
    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 ]
    participants will self-report via questionnaire their joy and satisfaction with their average physical activity level.


Estimated Enrollment: 81
Study Start Date: May 2014
Study Completion Date: April 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849978


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Isaac Lipkus, PhD Duke University School of Nursing
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01849978     History of Changes
Other Study ID Numbers: Pro00044422
First Submitted: May 6, 2013
First Posted: May 9, 2013
Last Update Posted: January 14, 2016
Last Verified: January 2016

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