Hormones and Physical Exercise (HOPE) Study

March 4, 2020 updated by: Yale University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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".
6 months
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".
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melinda Irwin, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0906005263
  • CA132931 (OTHER: Other Federal ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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