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Completed

NCT Number: NCT02682836

Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Cancer Hospital

Chapel Hill, North Carolina, 27519, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • Age 21 or older
  • Metastatic breast cancer (MBC) diagnosis - Stage IV
  • Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
  • Approval from the treating clinician to engage in moderate-intensity physical activity.
  • Patient-assessed ability to walk and engage in moderate physical activity
  • Proficient in English.
  • IRB approved signed written informed consent.
  • Willing and able to do all study requirements.

Exclusion criteria

  • One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
  • No more than 3 prior chemotherapy regimens.

Treatment and study plan

Walk With Ease

Behavioral

Primary outcomes

  1. changes in fatigue scores

    Time frame: at 3 months

    Evaluate change in PROMIS Fatigue scores from baseline to 3 months

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2016
Registry last updated
Jan 6, 2022

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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