Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Tailored Group
Intervention: Tailored Email (Behavioral)
Targeted Group
Intervention: Targeted Email (Behavioral)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Leanne Kaye
Doctoral Candidate
UNC Lineberger Comprehensive Cancer Center