Clinical trial NCT06500858: MBC Physical Activity Study
Official title: A Tailored Physical Activity Program to Address Physical Inactivity Amongst Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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
* 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

Primary outcomes:
measure: Physical activity improvement
timeFrame: At baseline and up to 6 weeks after initial post-assessment
Secondary outcomes:
measure: Patient adherence
timeFrame: At baseline and up to 6 weeks after initial post-assessment
measure: Mean patients' minutes of activity
timeFrame: At baseline and up to 6 weeks after initial post-assessment
measure: Change in physical function
timeFrame: At baseline and up to 6 weeks after initial post-assessment
measure: Change in quality of life
timeFrame: At baseline and up to 6 weeks after initial post-assessment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: