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Trial Title:
MBC Physical Activity Study
NCT ID:
NCT06500858
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Receive a welcome package with exercise equipment
Arm group label:
Supportive care (virtual exercise sessions)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Participate in virtual-exercise sessions
Arm group label:
Supportive care (virtual exercise sessions)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Receive access to optional drop-in classes
Arm group label:
Supportive care (virtual exercise sessions)
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Receive monthly newsletters
Arm group label:
Supportive care (virtual exercise sessions)
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Receive access to online fitness buddy matching program
Arm group label:
Supportive care (virtual exercise sessions)
Intervention type:
Other
Intervention name:
Physical Activity
Description:
Participate in a walking program
Arm group label:
Supportive care (virtual exercise sessions)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive care (virtual exercise sessions)
Summary:
This clinical trial evaluates the impact of a tailored physical activity program on
physical activity in patients with breast cancer that has spread from where it first
started to other places in the body (metastatic). It has been shown that decreased
physical activity contributes to poor performance and quality of life. Evidence has also
shown that exercise could improve physical fitness, physical functioning, quality of
life, and cancer-related fatigue, however, there is concern that it may not be available
to those with physical limitations. The proposed physical activity program offers a
comprehensive and individualized assessment for each metastatic breast cancer patient and
includes a high quality, tailored exercise home-based program designed by an advanced
qualified cancer exercise specialist. A tailored physical activity program may improve
physical activity in metastatic breast cancer patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female
- Aged 18 and older
- Able to read and speak English
- Diagnosed with metastatic breast cancer within 60 months of study enrollment
- Receiving treatment at the Sidney Kimmel Caner Center (SKCC) in Center City
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Insufficiently inactive defined as answer "no" to screening question "On average, do
you engage in at least 75 minutes a week of vigorous activity (like jogging) or at
least 150 minutes a week of moderate activity (like a brisk walk)?"
- Able to comprehend and sign a written informed consent (no cognitive decline)
- Willing to comply with all study procedures and be available for the duration of the
study through at least week 2 of 2Unstoppable
- Medically cleared by co-investigator or principal investigator (PI) to engage in
aerobic and resistance exercise intervention
- Access to a smart device and have an active wi-fi connection at home
Exclusion Criteria:
- Severe or unstable cardiopulmonary, metabolic, or renal disease
- Unable to walk safely without physical assistance of another person or assistive
device
- Any condition that may limit the ability to comply with behavioral and physical
recommendations of the virtual exercise program
- Pregnancy
Gender:
Female
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Kelly, DO
Phone:
215-955-4763
Email:
erin.kelly2@jefferson.edu
Start date:
September 6, 2024
Completion date:
October 30, 2025
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500858
