Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Jennifer Ligibel, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Beth Isreal Deaconess Medical Center||Boston, Massachusetts 02215|