Hormones and Physical Exercise (HOPE) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02056067
First received: February 4, 2014
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Arthralgia
Behavioral: Exercise
Behavioral: Attention Control (Health Education)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormones and Physical Exercise (HOPE) Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change from Baseline in Arthralgia Severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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".


Enrollment: 121
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056067

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Melinda Irwin, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02056067     History of Changes
Other Study ID Numbers: HIC0906005263
Study First Received: February 4, 2014
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Breast Diseases
Joint Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Pain
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014