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OpenTrials
Completed

NCT Number: NCT01845519

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lineberger Comprehensive Cancer Center/ University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Email

Behavioral

Participants will receive tailored emails.

Targeted Email

Behavioral

Participants will receive targeted emails.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Leanne Kaye

Other

Collaborators

  • UNC Lineberger Comprehensive Cancer Center
  • University of North Carolina

Registry information

Official study title

Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 3, 2013
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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