Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

NCT01900418 | Completed DMC

• 1 other identifier: 13-2321
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Pain; Breast Cancer

Keywords

breast cancer; aromatase inhibitors; physical activity; joint pain

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• Self-reported walking

  6 weeks

Other Outcomes (12)

• Self-reported fatigue

  6 weeks

• Self-reported joint stiffness

  6 week

• Pain

  6 weeks

Study Arms (2)

Walking

ACTIVE COMPARATOR

Walk with Ease

Behavioral: Walk with Ease

Wait list control

NO INTERVENTION

Wait list control receiving the active intervention 6 weeks later.

Interventions

Walk with Ease BEHAVIORAL

An evidence-based walking program

Walking

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or older
• have permission from physician to engage in moderate intensity physical activity

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Arthralgia; Breast Neoplasms; Motor Activity

Interventions

Walking; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Leigh F Callahan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Link Briggs Distinguished Professor of Medicine

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 16, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (1)