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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845519
• Other study ID #: IRB 121775
• Status: Completed
• Phase: N/A
• First received: April 25, 2013
• Last updated: May 28, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Lineberger Protocol Review CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Tailored Email
Participants will receive tailored emails.
• Targeted Email
Participants will receive targeted emails.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center/ University of North Carolina	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Leanne Kaye	UNC Lineberger Comprehensive Cancer Center, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No