CClinicalTrials.gg
CompletedNCT01845519Updated Jun 1, 2015

Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors

An interventional study of Tailored Email and Targeted Email in Sedentary Lifestyle, Breast Neoplasms and Survival Rate (Survivorship), sponsored by Leanne Kaye. Completed at 1 site in United States. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-01.

Sponsored by Leanne Kaye · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 90 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Leanne Kaye as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Tailored Group

    Behavioral: Tailored Email

  • Active comparator
    Targeted Group

    Behavioral: Targeted Email

Interventions

  • BehavioralTailored Email

    Participants will receive tailored emails.

  • BehavioralTargeted Email

    Participants will receive targeted emails.

06

What researchers measure

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).

    Time frame: 12 weeks

07

Study locations

1 site
  • Lineberger Comprehensive Cancer Center/ University of North Carolina
    Chapel Hill, North Carolina 27599, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01845519
Lead sponsor
Leanne Kaye
Collaborators
UNC Lineberger Comprehensive Cancer Center, University of North Carolina
Responsible party
Leanne Kaye (Doctoral Candidate, UNC Lineberger Comprehensive Cancer Center) — Sponsor-investigator
First posted
May 3, 2013
Start date
Jul 2013
Primary completion
Apr 2014
Completion
Jun 2014
Last update
Jun 1, 2015

Study contacts

Leanne Kaye, PhD
principal investigator · University of North Carolina
Dianne Ward, Ed.D
study director · University of North Carolina

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion