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

Primary Purpose

Sedentary Lifestyle, Breast Neoplasms, Survival Rate (Survivorship)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Email
Targeted Email
Sponsored by
Leanne Kaye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Lifestyle

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lineberger Comprehensive Cancer Center/ University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tailored Group

Targeted Group

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 25, 2013
Last Updated
May 28, 2015
Sponsor
Leanne Kaye
Collaborators
UNC Lineberger Comprehensive Cancer Center, University of North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01845519
Brief Title
Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors
Official Title
Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leanne Kaye
Collaborators
UNC Lineberger Comprehensive Cancer Center, University of North Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Breast Neoplasms, Survival Rate (Survivorship)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Group
Arm Type
Experimental
Arm Title
Targeted Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tailored Email
Intervention Description
Participants will receive tailored emails.
Intervention Type
Behavioral
Intervention Name(s)
Targeted Email
Intervention Description
Participants will receive targeted emails.
Primary Outcome Measure Information:
Title
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
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).
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Kaye, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dianne Ward, Ed.D
Organizational Affiliation
University of North Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center/ University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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