Exercise Intervention in Women With Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate-Intensity Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring metastatic breast cancer, exercise intervention
Eligibility Criteria
Inclusion Criteria:
- Metastatic or locally advanced breast cancer not amenable to curative surgery
- Life expectance of greater than 12 months
- English speaking
- Pre- and postmenopausal
- Performance status 0-1
Exclusion Criteria:
- Baseline exercise of more than 150 minutes/week
- Active brain metastases
- Uncontrolled cardiac disease
Sites / Locations
- Beth Isreal Deaconess Medical Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Immediate Exercise Group
Delayed Exercise Group
Arm Description
Exercise Intervention begins immediately
Exercise intervention delayed by 16 weeks
Outcomes
Primary Outcome Measures
To determine the impact of a 16 week exercise intervention on physical functioning and cardiorespiratory fitness in a group of patients with metastatic breast cancer.
Secondary Outcome Measures
To determine the impact of a 16-week exercise intervention on quality of life, fatigue and mood in a group of patients with metastatic breast cancer
To test the feasibility of an exploratory measure of health care utilization in a population of patients with metastatic breast cancer and potential impact on a 16-week exercise intervention on health care utilization.
Full Information
NCT ID
NCT00405782
First Posted
November 28, 2006
Last Updated
June 24, 2016
Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00405782
Brief Title
Exercise Intervention in Women With Metastatic Breast Cancer
Official Title
Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to evaluate the impact of moderate-intensity exercise (such as walking) on quality of life, energy level, endurance and mood in women with metastatic breast cancer. Studies have shown that women with early stage breast cancer who exercise during treatment have more energy, less sleep disturbance, less anxiety and depression, and better strength and endurance than women who do not exercise. These studies have also shown that women who exercised during treatment for early stage breast cancer did not develop injuries or increased fatigue from exercising during chemotherapy and radiation treatments. The investigators are conducting this trial to see if women with metastatic breast cancer experience similar benefits from exercise as women with earlier breast cancer. The investigators also wish to determine whether women with advanced disease are able to exercise safely during their treatment under the supervision of an exercise physiologist.
Detailed Description
Participants will be randomized to one of two groups. Study participants assigned to Group A will immediately participate in a 16-week exercise program, and participants assigned to Group B will wait 16 weeks before taking part in an exercise program.
Before beginning the exercise program (Group A) or waiting period (Group B), participants will undergo a series of tests to measure exercise capacity, fatigue level and quality of life. They will be asked to complete a series of questionnaires and meet with an exercise physiologist and undergo a treadmill test designed to measure physical fitness in patients with a chronic illness. The participant will complete the questionnaires again 8 weeks after enrolling in the protocol and will complete one final set and undergo a second treadmill test after the 16-week study period has ended.
Participants in Group A will be given a 16-week gym membership, as well as a heart rate monitor and a pedometer. They will meet with an exercise physiologist, who will design an exercise program for each participant. Participants will meet with the exercise physiologist weekly for 4 weeks, then once per month for the duration of the study. The target exercise goal will be 150 minutes of moderate-intensity exercise each week.
Participants will be given an exercise journal to record the minutes of cardiovascular exercise and steps taken each day. These journals will be reviewed by the exercise physiologist each week.
Participants in Group B will be allowed to exercise as much as they wish during the first 16-weeks of their time on the study, but they will not be given a formal exercise plan or a gym membership until the completion of the 16-week waiting period. During this time, they will also complete questionnaires at the time of study entry, 8 weeks after enrolling, and at the end of 16 weeks. After the 16-week delay period has passed, participants in Group B will be given a pedometer, heart rate monitor and 16-week gym membership. They will also meet with an exercise physiologist weekly for one month, and the exercise physiologist will design an individualized exercise plan for these participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
metastatic breast cancer, exercise intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Exercise Group
Arm Type
Active Comparator
Arm Description
Exercise Intervention begins immediately
Arm Title
Delayed Exercise Group
Arm Type
Active Comparator
Arm Description
Exercise intervention delayed by 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Exercise
Intervention Description
Exercise program designed by exercise physiologist
Primary Outcome Measure Information:
Title
To determine the impact of a 16 week exercise intervention on physical functioning and cardiorespiratory fitness in a group of patients with metastatic breast cancer.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
To determine the impact of a 16-week exercise intervention on quality of life, fatigue and mood in a group of patients with metastatic breast cancer
Time Frame
16 weeks
Title
To test the feasibility of an exploratory measure of health care utilization in a population of patients with metastatic breast cancer and potential impact on a 16-week exercise intervention on health care utilization.
Time Frame
16 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic or locally advanced breast cancer not amenable to curative surgery
Life expectance of greater than 12 months
English speaking
Pre- and postmenopausal
Performance status 0-1
Exclusion Criteria:
Baseline exercise of more than 150 minutes/week
Active brain metastases
Uncontrolled cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Isreal Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise Intervention in Women With Metastatic Breast Cancer
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