Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

NCT ID: NCT01900418

Last Updated: 2016-08-08

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-06-30

Brief Summary

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For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.

Detailed Description

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Conditions

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Joint Pain Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Walking

Walk with Ease

Group Type ACTIVE_COMPARATOR

Walk with Ease

Intervention Type BEHAVIORAL

An evidence-based walking program

Wait list control

Wait list control receiving the active intervention 6 weeks later.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Walk with Ease

An evidence-based walking program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks
* Experiencing more than mild joint pain/symptoms
* 21 or older
* have permission from physician to engage in moderate intensity physical activity

Exclusion Criteria

* Undergoing chemotherapy and/or radiation therapy at any time during the study period
* Scheduled for major surgery during the study period
* Presently engaged in high levels of physical activity on a daily basis
* Less than 21 years of age
* Unable to walk or engage in moderate intensity physical activity
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Leigh F Callahan, PhD

Mary Link Briggs Distinguished Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leigh F Callahan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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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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13-2321

Identifier Type: -

Identifier Source: org_study_id

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