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40 Years
65 Years
Not Enrolling
Sedentary Lifestyle, Breast Neoplasms, Survival Rate (Survivorship)

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Trial Information

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.

Inclusion Criteria:

- Female

- 40-65 years of age

- History of breast cancer stage I-IIIa

- Completed cancer treatments (maintenance/ hormonal therapy okay)

- 2-7 years post-treatment

- Sedentary (<60 minutes/week; Measure: self-report 7 day PAQ)

- Physician approval to engage in physical activity (Measure:PAR-Q)

- Technology access and skills (Measure: Technology questionnaire)

- Regular access to personal computer/ broadband internet and email account

- Comfortability using internet, and web-based tools

- US Resident

- Informed consent reviewed and signed

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

- Engaging in regular moderate to vigorous physical activity

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).

Outcome Description:

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).

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Leanne Kaye, MPH, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina


United States: Lineberger Protocol Review Committee

Study ID:

IRB 121775



Start Date:

August 2013

Completion Date:

February 2014

Related Keywords:

  • Sedentary Lifestyle
  • Breast Neoplasms
  • Survival Rate (Survivorship)
  • Breast Neoplasms
  • Neoplasms



Lineberger Comprehensive Cancer Center/ University of North Carolina Chapel Hill, North Carolina  27599