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

NCT ID: NCT01845519

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Sedentary Lifestyle Breast Neoplasms Survival Rate (Survivorship)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Tailored Group

Group Type EXPERIMENTAL

Tailored Email

Intervention Type BEHAVIORAL

Participants will receive tailored emails.

Targeted Group

Group Type ACTIVE_COMPARATOR

Targeted Email

Intervention Type BEHAVIORAL

Participants will receive targeted emails.

Interventions

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Tailored Email

Participants will receive tailored emails.

Intervention Type BEHAVIORAL

Targeted Email

Participants will receive targeted emails.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Leanne Kaye

OTHER

Sponsor Role lead

Responsible Party

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Leanne Kaye

Doctoral Candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Leanne Kaye, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Dianne Ward, Ed.D

Role: STUDY_DIRECTOR

University of North Carolina

Locations

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Lineberger Comprehensive Cancer Center/ University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 121775

Identifier Type: -

Identifier Source: org_study_id

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