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.
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
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
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 1, 2015
December 1, 2013
9 months
April 25, 2013
May 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
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
Study Arms (2)
Tailored Group
EXPERIMENTALTargeted Group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Female
- years of age
- History of breast cancer stage I-II
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leanne Kayelead
- UNC Lineberger Comprehensive Cancer Centercollaborator
- University of North Carolinacollaborator
Study Sites (1)
Lineberger Comprehensive Cancer Center/ University of North Carolina
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leanne Kaye, PhD
University of North Carolina
- STUDY DIRECTOR
Dianne Ward, Ed.D
University of North Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctoral Candidate
Study Record Dates
First Submitted
April 25, 2013
First Posted
May 3, 2013
Study Start
July 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
June 1, 2015
Record last verified: 2013-12