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Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328313
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date April 30, 2020
Study Start Date  ICMJE October 2014
Actual Primary Completion Date January 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group [ Time Frame: 12 months ]
    The comparison group will be taken from another study
  • To measure the changes in the level of p16 expression from baseline and end of chemotherapy. [ Time Frame: 2 - 6 months ]
    The study will look at the change of p16 expression within patients on this study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • To measure changes in body compositional aspects of lean body mass (LBM) [ Time Frame: 12 months ]
    As measured by DEXA
  • To measure changes in body compositional aspects of fat tissue mass (FM) [ Time Frame: 12 months ]
    As measured by DEXA
  • To measure changes in body compositional aspects of percentage body fat (BF) [ Time Frame: 12 months ]
    As measured by DEXA
  • To measure change in physical activity over the course of the study [ Time Frame: 12 months ]
    As measured by engagement in walking survey
  • To measure change in physical function over the course of the study [ Time Frame: 12 months ]
    As measured by the Short Physical Performance Battery
  • To measure change in fatigue over the course of the study [ Time Frame: 12 months ]
    As measured by the FACIT-F
  • To measure change in quality of life over the course of the study [ Time Frame: 12 months ]
    As measured by the FACT-B
  • To measure change in self-efficacy over the course of the study [ Time Frame: 12 months ]
    As measured by the PSEFSM and OEE
  • To measure retention during the study [ Time Frame: 12 months ]
    • Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.
  • To measure safety of the walking program [ Time Frame: 12 months ]
    • Safety will be defined as any adverse events potentially related to the intervention, including falls, which are reported by study participants to the Study Team.
  • To measure overall satisfaction with the program [ Time Frame: 12 months ]
    As measured by a satisfaction questionnaire
  • To average the number of daily and weekly steps per participant [ Time Frame: 12 months ]
    As measure via an continuous accelerometer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Official Title  ICMJE LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Brief Summary To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
Detailed Description LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Breast Cancer
  • Aging
  • Physical Activity
Intervention  ICMJE Behavioral: Walk with Ease Program
The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.
Study Arms  ICMJE Experimental: Intervention Cohort
Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.
Intervention: Behavioral: Walk with Ease Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2018)
134
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
100
Actual Study Completion Date  ICMJE January 16, 2019
Actual Primary Completion Date January 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 65 or older, female
  • Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
  • Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
  • English speaking
  • IRB approved, signed written informed consent
  • Approval from their treating physician to engage in moderate-intensity physical activity
  • Patient-assessed ability to walk and engage in moderate physical activity
  • Willing and able to meet all study requirements.

Exclusion Criteria:

- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02328313
Other Study ID Numbers  ICMJE LCCC1410
14-2074 ( Other Identifier: UNC IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyman Muss, MD University of North Carolina
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP