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Hormones and Physical Exercise (HOPE) Study

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ClinicalTrials.gov Identifier: NCT02056067
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE February 4, 2014
First Posted Date  ICMJE February 5, 2014
Last Update Posted Date March 5, 2020
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • Change from Baseline in Arthralgia Severity [ Time Frame: 6 months ]
    Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".
  • Change from Baseline in Arthralgia Severity [ Time Frame: 12 months ]
    Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormones and Physical Exercise (HOPE) Study
Official Title  ICMJE Hormones and Physical Exercise (HOPE) Study
Brief Summary The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.
Detailed Description The investigators propose to examine, in 121 postmenopausal breast cancer survivors who have been taking an AI for at least 2 months and are currently experiencing at least mild arthralgia associated with AI use, the effect of a randomized controlled exercise intervention vs. attention control (health education) on severity of arthralgia, endocrine-related Quality of Life(QOL), Bone Mineral Density(BMD), and mediators/mechanisms influencing the effect of exercise on arthralgia severity. Women will be randomized to a year long exercise program or attention control group. Women randomized to exercise will participate in 150 min/wk of aerobic exercise and a twice-weekly strength training program. The investigators will conduct baseline, six-, and 12-month clinic visits, as well as a 3- and 9-month mailing to evaluate the effect of the intervention on study outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Arthralgia
Intervention  ICMJE
  • Behavioral: Exercise
    The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.
  • Behavioral: Attention Control (Health Education)
    The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest
Study Arms  ICMJE
  • Experimental: Exercise
    The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.
    Intervention: Behavioral: Exercise
  • Active Comparator: Attention Control (Health Education)
    The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest
    Intervention: Behavioral: Attention Control (Health Education)
Publications *

*   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: February 4, 2014)
121
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women (defined as the surgical or natural absence of menstrual cycles for at least 1 year prior to breast cancer diagnosis).
  • 75 years or younger
  • AJCC Stages I-IIIC Breast Cancer
  • Taking an AI for at least 2 months
  • Currently experiencing at least mild arthralgia (= or > 3 on the BPI) associated with AI use
  • Physically able to exercise and physician consent to start an exercise program
  • Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity sports activity) within the past year and low fitness level
  • No more than one strength training session per week within the past year
  • Agrees to be randomly assigned to either exercise or attention control
  • Gives informed consent to participate in all study activities
  • Able to come for baseline, 6-, and 12-month clinic visits and strength training sessions (6-month intervention study - able to come for baseline, 6-month clinic visits and strength training sessions).
  • Mentally competent

Exclusion Criteria:

  • Lymphedema with self reported 'flare up' in the past 4 months
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, 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 NCT02056067
Other Study ID Numbers  ICMJE 0906005263
CA132931 ( Other Identifier: Other Federal ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yale University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melinda Irwin, PhD Yale University
PRS Account Yale University
Verification Date March 2020

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