- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845519
Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors
Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.
The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.
Study Overview
Status
Intervention / Treatment
Detailed Description
More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.
AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.
AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Lineberger Comprehensive Cancer Center/ University of North Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- 40-70 years of age
- History of breast cancer stage I-II
- 2-10 years post-treatment
- Sedentary
- Technology access and skills
- Regular access to personal computer/ broadband internet and email account
- Comfortability using internet, and web-based tools
- US Resident
Exclusion Criteria:
- Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
- Current secondary cancer diagnosis/ treatment
- Inability to ambulate
- Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
- Engaging in regular moderate to vigorous physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored Group
|
Participants will receive tailored emails.
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Active Comparator: Targeted Group
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Participants will receive targeted emails.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
Time Frame: 12 weeks
|
The primary outcome will be measured using weekly step data as measured by a commercially available accelerometer.
The primary outcome will be the difference in weekly steps between the intervention and comparison group at the end of the intervention (week 12).
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leanne Kaye, PhD, University of North Carolina
- Study Director: Dianne Ward, Ed.D, University of North Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 121775
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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