Anatomic Stage IV Breast Cancer AJCC v8NCT06500858
MBC Physical Activity Study
A study testing Exercise Intervention, Health Promotion and Education and Internet-Based Intervention in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- What is being tested?
- Exercise Intervention, Health Promotion and Education and Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)?"
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Tailored Physical Activity Program to Address Physical Inactivity Amongst Metastatic Breast Cancer Patients
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.
Read the detailed description
This single-arm study aims to evaluate the impact of participation in a physical rehabilitation program tailored for metastatic breast cancer (MBC) patients on physical activity, quality of life (QOL), and patient satisfaction.
The study will enroll approximately 50 female patients aged 18 or older who were initially diagnosed with metastatic disease within 60 months of enrollment and are continuing treatment for metastatic disease at Jefferson Health. Enrollment will be balanced at an approximate 1:1 ratio, including 25 African American or Hispanic (non-White) patients and 25 White Caucasian patients who meet eligibility criteria during the 24-month study period.
The primary goal is to develop a physical activity program that addresses a key social determinant of health-physical inactivity-particularly among women of color with MBC. The study will further assess the impact of this program on physical activity, physical function, and quality of life.
The proposed program will provide a comprehensive, individualized assessment for each participant and include a high-quality, home-based exercise regimen directed by an advanced cancer exercise specialist.
Intervention:
A virtual program through 2Unstoppable will be offered. This 6-week, small-group program combines cardio and strength training to help women with metastatic cancer safely and confidently engage in physical activity in a supportive environment. The program meets exercise recommendations from the American Cancer Society (ACS) and the American College of Sports Medicine (ACSM) for cancer patients and survivors and is led by an advanced cancer exercise specialist.
- Being tested
- Exercise Intervention, Health Promotion and Education, Internet-Based Intervention, Physical Activity, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
Receive a welcome package with exercise equipment
Exercise InterventionOther
Participate in virtual-exercise sessions
Exercise InterventionOther
Receive access to optional drop-in classes
Health Promotion and EducationOther
Receive monthly newsletters
Internet-Based InterventionOther
Receive access to online fitness buddy matching program
Physical ActivityOther
Participate in a walking program
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (virtual exercise sessions) | Experimental | The 2Unstoppable Strong program is 6 weeks with a weekly live via Zoom but also recorded exercise class. All participants will complete a phone screening (with 2Unstoppable) to determine eligibility and interest; a 30-minute assessment with the instructor over Zoom or FaceTime to review health history, concerns, \& limitations; then provide a signed Physician Release, a signed liability waiver and a completed health questionnaire. Receives: Other: Exercise Intervention; Other: Health Promotion and Education; Other: Internet-Based Intervention; Other: Physical Activity; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity improvement
Physical activity improvement will be measured by mean change in minutes of physical activity per week from baseline. Intervention effects will be estimated by using a follow-up indicator in longitudinal general estimating equations (GEE) linear regression model to test for a difference from zero for the follow-up indicator parameter estimate with a 2-sided Wald test at alpha=0.05 significance level along with a 95% confidence interval.
Measured: At baseline and up to 6 weeks after initial post-assessment
Secondary outcomes (4)
Patient adherence
GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling.
Measured: At baseline and up to 6 weeks after initial post-assessment
Mean patients' minutes of activity
GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling.
Measured: At baseline and up to 6 weeks after initial post-assessment
Change in physical function
GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling.
Measured: At baseline and up to 6 weeks after initial post-assessment
Change in quality of life
GEE linear or logistic regression models will be constructed to include a follow-up indicator to estimate the intervention effects along with 95% confidence intervals. Relationships between responses and other study variables will be explored by summary statistical analysis and logistic regression modeling
Measured: At baseline and up to 6 weeks after initial post-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start6 Sep 2024
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500858
- Sponsor's protocol ID
- 2024-3107
- Other IDs
- JT 41644
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Physical Activity Program to Address Physical Inactivity Amongst Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06500858
- Acronym / sponsor ID
- 2024-3107
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-arm study aims to evaluate the impact of participation in a physical rehabilitation program tailored for metastatic breast cancer (MBC) patients on physical activity, quality of life (QOL), and patient satisfaction.
The study will enroll approximately 50 female patients aged 18 or older who were initially diagnosed with metastatic disease within 60 months of enrollment and are continuing treatment for metastatic disease at Jefferson Health. Enrollment will be balanced at an approximate 1:1 ratio, including 25 African American or Hispanic (non-White) patients and 25 White Caucasian patients who meet eligibility criteria during the 24-month study period.
The primary goal is to develop a physical activity program that addresses a key social determinant of health-physical inactivity-particularly among women of color with MBC. The study will further assess the impact of this program on physical activity, physical function, and quality of life.
The proposed program will provide a comprehensive, individualized assessment for each participant and include a high-quality, home-based exercise regimen directed by an advanced cancer exercise specialist.
Intervention:
A virtual program through 2Unstoppable will be offered. This 6-week, small-group program combines cardio and strength training to help women with metastatic cancer safely and confidently engage in physical activity in a supportive environment. The program meets exercise recommendations from the American Cancer Society (ACS) and the American College of Sports Medicine (ACSM) for cancer patients and survivors and is led by an advanced cancer exercise specialist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (virtual exercise sessions) | Experimental | Other: Exercise Intervention, Other: Health Promotion and Education, Other: Internet-Based Intervention, Other: Physical Activity, Other: Questionnaire AdministrationThe 2Unstoppable Strong program is 6 weeks with a weekly live via Zoom but also recorded exercise class. All participants will complete a phone screening (with 2Unstoppable) to determine eligibility and interest; a 30-minute assessment with the instructor over Zoom or FaceTime to review health history, concerns, \& limitations; then provide a signed Physician Release, a signed liability waiver and a completed health questionnaire. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionReceive a welcome package with exercise equipment | Other | Supportive care (virtual exercise sessions) |
| Exercise InterventionParticipate in virtual-exercise sessions | Other | Supportive care (virtual exercise sessions) |
| Exercise InterventionReceive access to optional drop-in classes | Other | Supportive care (virtual exercise sessions) |
| Health Promotion and EducationReceive monthly newsletters | Other | Supportive care (virtual exercise sessions) |
| Internet-Based InterventionReceive access to online fitness buddy matching program | Other | Supportive care (virtual exercise sessions) |
| Physical ActivityParticipate in a walking program | Other | Supportive care (virtual exercise sessions) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (virtual exercise sessions) |
Primary outcome
Physical activity improvement
Time frame: At baseline and up to 6 weeks after initial post-assessment
Physical activity improvement will be measured by mean change in minutes of physical activity per week from baseline. Intervention effects will be estimated by using a follow-up indicator in longitudinal general estimating equations (GEE) linear regression model to test for a difference from zero for the follow-up indicator parameter estimate with a 2-sided Wald test at alpha=0.05 significance level along with a 95% confidence interval.
4 secondary outcomes
Patient adherence
Time frame: At baseline and up to 6 weeks after initial post-assessment
Mean patients' minutes of activity
Time frame: At baseline and up to 6 weeks after initial post-assessment
Change in physical function
Time frame: At baseline and up to 6 weeks after initial post-assessment
Change in quality of life
Time frame: At baseline and up to 6 weeks after initial post-assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Health Promotion and Education and Internet-Based Intervention in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity improvement (time frame: At baseline and up to 6 weeks after initial post-assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.