Enhancing Exercise in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Enhancing Exercise in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849978
• Other study ID #: Pro00044422
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: January 12, 2016
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in number of minutes of moderate to strenuous physical activity	participants will self-report minutes of physical activity at baseline, 1 month, and 3 months after receiving intervention materials.	baseline, 1 month and 3 months	No
Secondary	changes in joy and satisfaction with physical activity	participants will self-report via questionnaire their joy and satisfaction with their average physical activity level.	baseline, 1 month, and 3 months	No