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Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Primary Purpose

Joint Pain, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk with Ease
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Joint Pain focused on measuring breast cancer, aromatase inhibitors, physical activity, joint pain

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Walking

Wait list control

Arm Description

Walk with Ease

Wait list control receiving the active intervention 6 weeks later.

Outcomes

Primary Outcome Measures

Self-reported joint pain
A valid and reliable 10cm Visual Analog Scale will be used to assess self-reported joint pain. This scale has been used in numerous trials.

Secondary Outcome Measures

Self-reported walking
This will be measured by the number of days walked per week and the number of minutes per walk.

Full Information

First Posted
July 11, 2013
Last Updated
August 5, 2016
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01900418
Brief Title
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Official Title
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Pain, Breast Cancer
Keywords
breast cancer, aromatase inhibitors, physical activity, joint pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking
Arm Type
Active Comparator
Arm Description
Walk with Ease
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Wait list control receiving the active intervention 6 weeks later.
Intervention Type
Behavioral
Intervention Name(s)
Walk with Ease
Intervention Description
An evidence-based walking program
Primary Outcome Measure Information:
Title
Self-reported joint pain
Description
A valid and reliable 10cm Visual Analog Scale will be used to assess self-reported joint pain. This scale has been used in numerous trials.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Self-reported walking
Description
This will be measured by the number of days walked per week and the number of minutes per walk.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Self-reported fatigue
Description
A valid and reliable Visual Analog Scale will be used to assess fatigue.
Time Frame
6 weeks
Title
Self-reported joint stiffness
Description
A valid and reliable Visual Analog Scale will be used to assess joint stiffness.
Time Frame
6 week
Title
Pain
Description
The Brief Pain Inventory Short Form will be used to assess pain. It is a valid and reliable instrument that has been used in other studies of breast cancer survivors.
Time Frame
6 weeks
Title
Lower extremity pain and function
Description
The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function.
Time Frame
6 weeks
Title
Quality of life
Description
Functional Assessment of Cancer Therapy-General (FACT-G)
Time Frame
6 weeks
Title
Beliefs about engaging in exercise
Description
Expectations for Exercise (OEE) scale
Time Frame
6 weeks
Title
Self-efficacy to manage joint pain
Description
Arthritis Self-Efficacy Scale (ASE)
Time Frame
6 weeks
Title
Engagement in Physical Activity
Description
Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011
Time Frame
6 weeks
Title
Helplessness
Description
Rheumatology Attitudes Index (RAI)
Time Frame
6 weeks
Title
Adverse event
Description
Self-report of any adverse events will be used to monitor safety.
Time Frame
6 weeks
Title
Feasibility
Description
Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.
Time Frame
6 weeks
Title
Tolerability
Description
Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh F Callahan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

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