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Completed

NCT Number: NCT01900418

Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

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.

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Key information

Conditions

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

Age range

21 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk With Ease

Behavioral

An evidence-based walking program

Primary outcomes

  1. Self-reported joint pain

    Time frame: 6 weeks

    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 outcomes

  1. Self-reported walking

    Time frame: 6 weeks

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

Other outcomes

  1. Self-reported fatigue

    Time frame: 6 weeks

    A valid and reliable Visual Analog Scale will be used to assess fatigue.

  2. Self-reported joint stiffness

    Time frame: 6 week

    A valid and reliable Visual Analog Scale will be used to assess joint stiffness.

  3. Pain

    Time frame: 6 weeks

    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.

  4. Lower extremity pain and function

    Time frame: 6 weeks

    The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function.

  5. Quality of life

    Time frame: 6 weeks

    Functional Assessment of Cancer Therapy-General (FACT-G)

  6. Beliefs about engaging in exercise

    Time frame: 6 weeks

    Expectations for Exercise (OEE) scale

  7. Self-efficacy to manage joint pain

    Time frame: 6 weeks

    Arthritis Self-Efficacy Scale (ASE)

  8. Engagement in Physical Activity

    Time frame: 6 weeks

    Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011

  9. Helplessness

    Time frame: 6 weeks

    Rheumatology Attitudes Index (RAI)

  10. Adverse event

    Time frame: 6 weeks

    Self-report of any adverse events will be used to monitor safety.

  11. Feasibility

    Time frame: 6 weeks

    Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.

  12. Tolerability

    Time frame: 6 weeks

    Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 16, 2013
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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