Enhancing Exercise in Breast Cancer Survivors
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started May 2014
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJanuary 14, 2016
January 1, 2016
10 months
May 6, 2013
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
changes in joy and satisfaction with physical activity
baseline, 1 month, and 3 months
Study Arms (2)
Control arm
ACTIVE COMPARATORParticipants 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.
Habit Formation Arm
ACTIVE COMPARATORParticipants in this arm will receive all of the intervention materials.
Interventions
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.
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.
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.
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 Criteria
You may qualify if:
- no health restrictions on performing moderate to strenuous physical activity
- must be 18 years or older and able to give legal consent
You may not qualify if:
- may not be participating in another research study regarding exercise
- restrictions on performing physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isaac Lipkus, PhD
Duke University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 9, 2013
Study Start
May 1, 2014
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01