MastectomyStrongSurvivorNCT07071896
A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors
A study testing 16 weeks remotely exercise program in people with Mastectomy, run by University of California, San Diego at 2 sites in United States.
Trial summary
The investigators cancer rehabilitation/recovery program, Strong Survivor, has been designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- 16 weeks remotely exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2025to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
In order to be eligible to participate in this study, an individual must meet all the following criteria:
- Persons, aged 18+
- Undergone breast cancer surgery within the 4 weeks of being contacted for pre-screening
- Acceptable surgery includes unilateral or bilateral mastectomy (Lymph node surgery is NOT required but is still acceptable)
- Own a computer or alternative device capable of real-time Zoom videoconferencing, including access to internet or cellular connectivity sufficient in broadband. This requires a screen of at least 7 inches (a cell phone is large enough for us to see the participant, but not for the participant to see us).
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
An individual who meets any of the following criteria will be excluded from participation in this study:
- Have sustained a previous fall-related fracture within the last 2 years;
- have poorly controlled cardiovascular disease, pulmonary disease, or a debilitating musculoskeletal or neurological condition severely limiting function/ability to perform the exercise program as determined by the breast surgeon at screening for trial enrollment
- experience vertigo or dizziness/light headedness observed at enrollment or during initial occupational therapy evaluation.
- are on multiple benzodiazepine or neuroleptic medications.
- Pregnant or trying to become pregnant -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
UCSD
San Diego, California, 92037
Sara Grossi, MD
- Recruiting
UCSD
San Diego, California, 92093
Shoshi Barkai, MS, 619-736-3450, strongfoundations619@gmail.com
Sara M Grossi, MD
About this study
Official title: Strong Survivors: A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors
The investigators cancer rehabilitation/recovery program, Strong Survivor, has been designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting. The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy candidate, all with extensive training in both group and individualized exercise for geriatric and cancer survivor populations. Strong Survivor is 16-week iterative curricular program with three core components: aerobic fitness, balance and mobility, and muscular strength and power. Classes will be held twice per week. The first 4 classes will be deployed in a small class of up to 5 people (first 2 weeks), then one class per week with the small class and one class per week is with a larger class of up to 15 people (weeks 3 and 4). The program is then continued for 12 additional weeks in a larger class using principles and exercises specifically trained during the small group classes.
All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.
Read more
Participants will need to have a minimal adequate space and technology to accommodate this instructional method. Specifically, they will require an internet connected device with a camera that is at least 7 inches square. (tablet size or larger).
Additionally, participants' will need to have adequate space to both set up a computer/camera and move around. The minimal acceptable space for this is 6+ feet with an unobstructed view (from a table for instance) of a 2 x 2 open space.
All study participants will complete a clinic visit before they join the classes and after the last class to evaluate cardiorespiratory fitness, strength, balance and posture and answer questionnaires about quality of life and system usability.
Read the detailed description
Recovery Following Surgery Program: The investigators cancer recovery program, Strong Survivors is designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting.
The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy, all with extensive training in both group and individualized exercise for geriatric populations, and with the input of individuals with experience working with cancer survivors. As such, Strong Survivors is a 16-week iterative curricular program with three core components: cardiovascular fitness, balance and postural stability, and muscular strength and power. All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.
Participants will need to have a minimal adequate space and technology to accommodate this instructional method. Specifically, they will require an internet connected device with a camera that is at least 7 inches square. (tablet size or larger). While a cell phone is likely adequate for the investigators to see participants, it is not sufficiently large for them to see and follow exercise instruction.
Additionally, participants will need to have adequate space to both set up a computer/camera and move around. The minimal acceptable space for this is 6+ feet with an unobstructed view (from a table for instance) of a 2 x 2 open space. Participants will be coached to place the computer/camera/tablet/etc. at the position ~6 feet away and then stay within the 2x2 foot viewing area during exercise during the at-home zoom based testing (that occurs before the exercise sessions begin) Participants will be recruited so that they begin instruction in groups of 5 (i.e. the intervention will start as soon as 5 participants are recruited) and provided with 2 classes per week for 2 weeks where fundamental exercises are trained and reviewed. The following 2 weeks participants will continue to receive 1 small group class and will also be "added" to the large group class for 1 class per week. For the remaining three months of the intervention (12 weeks) participants will continue to engage in 2 large group classes per week.
Small group classes will be organized at the time of recruitment at 2x per week that matches the scheduling needs of all participants. This will, necessarily, be different for each recruited cohort.
Small group instruction: Five (5) participants will be paired with a master trainer (i.e. >1 year experience training in the zoom based environment and MS degree in exercise physiology, kinesiology, or athletic training) and a junior assistant. The master trainer will provide instruction and review participant performance while the junior assistant will provide support in terms of ensuring appropriate camera positioning (both for instructor and participant) and participant observation for signs of undue distress or difficulty.
Larger group instruction: After 2 weeks of small group instruction participants will be added to the growing group of individuals who have completed the small group instruction but not an additional 12 weeks. In concept this group could grow to infinite levels, but for the purposes of substudy 1 the largest the group could ever be is 15 individuals (the entire cohort). The larger group will also have a master trainer (i.e. >1 year experience training in the zoom based environment and MS degree in exercise physiology, kinesiology, or athletic training) and a junior assistant but will also be joined by a second junior trainer (BS or higher in exercise physiology, kinesiology, or athletic training or certification by a national recognized organization for personal training like ACSM, NASM, or ACE). One of the trainers will always be specifically monitoring participants to provide cues to ensure safety and maximize exercise benefits. The other trainer will both model exercises and provide feedback and the junior assistant will provide support in terms of ensuring appropriate camera positioning and providing participant observation.
All study participants will complete a clinic visit before they join the classes and after the last class to evaluate cardiorespiratory fitness, strength, balance and posture and answer questionnaires about quality of life and system usability.
- Conditions
- Mastectomy
- Being tested
- 16 weeks remotely exercise program
- Keywords
- Exercise, Mastectomy, rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 weeks remotely exercise programOther
16 weeks, twice per week, remotely exercise program
| Study group | Role | What they receive |
|---|---|---|
| Strong Survivors | Experimental | 16 week, twice weekly, remote exercise program Receives: Other: 16 weeks remotely exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
The number of sessions each participant attended (out of the total number of sessions offered) will be recorded and used to evaluate engagement in the tele-video real time exercise program in a geriatric breast cancer patient population.
A participant is considered to have completed the study if he or she has completed all phases of the study including responding to follow up queries regarding falls for up to 1 year following the final measurement visit. Acceptability is based on attendance.
Measured: 16 weeks
Secondary outcomes (14)
Cardiorespiratory Fitness: Time taken to reach 85% of age predicted heart rate max
The time taken to reach 85% of age predicted heart rate max , from a submaximal exercise testing on a treadmill, will be used to evaluate Cardiorespiratory Fitness; pre and post program times will be compared for each study participant.
Measured: Before the beginning and at the end of the 16 weeks program
Strength and Balance
Short Physical Performance Battery test (4-part validated scale for fall risk) will be used to evaluate Strength and Balance
Measured: Before the beginning and at the end of the 16 weeks program
Fall Risk assessment
The Timed Up and Go, Standardized assessment of functional mobility, will be used for Fall Risk assessment
Measured: Before the beginning and at the end of the 16 weeks program
Balance
The Better Balance Testing, measure of proprioceptive and vestibular function utilizing computerized dynamic posturography, will be use to measure balance
Measured: Before the beginning and at the end of the 16 weeks program
Fall Risk
The 25 foot walk, standardized assessment of gait speed and variability associated with fall risk, will be used to evaluate fall risk
Measured: Before the beginning and at the end of the 16 weeks program
Muscular Strength
The 30 Second Chair Stands, common field measure of muscular strength and endurance of the legs, will be used to evaluate legs muscular strength. This score is evaluated relative to a person's age and gender and a lower score in seconds indicates a shorter time to complete the task and represents higher strength and endurance of legs.
Measured: Before the beginning and at the end of the 16 weeks program
Posture
The Occipital to Wall Distance, measurement of kyphotic curvature of the spine, will be used to assess posture
Measured: Before the beginning and at the end of the 16 weeks program
Posture
The Block Measurement, measurement of kyphotic curvature of the spine, will be used to assess posture
Measured: Before the beginning and at the end of the 16 weeks program
Posture
Multiple measures of height, while standing normally versus standing "as tall as possible" (indicative of non-specific postural deficiencies) will be used to evaluate posture
Measured: Before the beginning and at the end of the 16 weeks program
Body Composition
Bio-electrical Impedance, non-invasive assessment of body composition, will be used to evaluate fat mass and muscle mass; those will be measured at the beginning of the program and the end of the program and the difference will be calculated for each study participant. Bioimpedance data can estimate parameters like body fat, lean body mass, and total body water which are calculated as percentages. While height and weight data are gathered during the bioimpedance measurement, they are not a specific reportable outcome measure.
Measured: Before the beginning and at the end of the 16 weeks program
Physical Activity level
Accelerometry, non Invasive home based measure of activity, will be used to evaluate the time spent in moderate-to-vigorous physical activity (MVPA) before the program and at the end of the program; the difference in time spent in MVPA will be calculated for each study participant. The accelerometer will be worn for a week before the program begins and for a week after the program.
Measured: Before the beginning and at the end of the 16 weeks program
Quality of Life assessment via PROMIS-29 questionnaire
The PROMIS-29 questionnaire is a patient-reported outcome (PRO) measure that assesses seven key health domains to evaluate Physical Function, Fatigue, Pain Interference, Depression, Anxiety, Ability to Participate in Social Roles and Activities, Sleep Disturbance and Pain Intensity. Raw scores range from 4 to 20 in each domain with the lowest score of 4 indicating no issues and maximum 20 most issues. It is scored by averaging all item responses for each dimension to create subscores, which are then combined to produce global physical and mental health scores. The pain scale is just one question with zero having no pain to 10 being worst pain. Changes in score from before the program to after the program will be calculated for each study participant.
Measured: Before the beginning and at the end of the 16 weeks program
System Usability
System Usability Scale (SUS) is a validated questionnaire designed to understand the ease of use of new systems or programs using a 5 element Likert scale per question. A higher score indicates a higher acceptability. SUS will be administered at the end of the program.
Measured: At the end of the 16 weeks program
Quality of life using FACT B questionnaire
The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of Health-Related Quality of Life in breast cancer patients: Physical (PWB), social (SWB), emotional (EWB), functional well-being (FWB) as well as a breast-cancer subscale (BCS). Questions ask about the last 7 days and responses are on a 5 point Likert-type scale. Multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered produces a subscale score (from 0 to 28 for PWB, SWB, FWB; 0 to 24 for EWB; 0 to 40 for BCS). Adding subscale scores will derive total scores. The higher the score, the better the Quality of Life. Scores will be calculated for each participant and before and after program scores will be compared.
Measured: Before the beginning and at the end of the 16 weeks program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start10 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Grossi, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071896
- Sponsor's protocol ID
- 809843
- Acronym
- StrongSurvivor
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Survivors: A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07071896
- Acronym / sponsor ID
- StrongSurvivor / 809843
- Conditions
- Mastectomy
- Keywords
- Exercise, Mastectomy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (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.
The investigators cancer rehabilitation/recovery program, Strong Survivor, has been designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting. The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy candidate, all with extensive training in both group and individualized exercise for geriatric and cancer survivor populations. Strong Survivor is 16-week iterative curricular program with three core components: aerobic fitness, balance and mobility, and muscular strength and power. Classes will be held twice per week. The first 4 classes will be deployed in a small class of up to 5 people (first 2 weeks), then one class per week with the small class and one class per week is with a larger class of up to 15 people (weeks 3 and 4). The program is then continued for 12 additional weeks in a larger class using principles and exercises specifically trained during the small group classes.
All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.
Participants will need to have a minimal adequate space and technology to accommodate this instructional method. Specifically, they will require an internet connected device with a camera that is at least 7 inches square. (tablet size or larger).
Additionally, participants' will need to have adequate space to both set up a computer/camera and move around. The minimal acceptable space for this is 6+ feet with an unobstructed view (from a table for instance) of a 2 x 2 open space.
All study participants will complete a clinic visit before they join the classes and after the last class to evaluate cardiorespiratory fitness, strength, balance and posture and answer questionnaires about quality of life and system usability.
Detailed description
Recovery Following Surgery Program: The investigators cancer recovery program, Strong Survivors is designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting.
The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy, all with extensive training in both group and individualized exercise for geriatric populations, and with the input of individuals with experience working with cancer survivors. As such, Strong Survivors is a 16-week iterative curricular program with three core components: cardiovascular fitness, balance and postural stability, and muscular strength and power. All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.
Participants will need to have a minimal adequate space and technology to accommodate this instructional method. Specifically, they will require an internet connected device with a camera that is at least 7 inches square. (tablet size or larger). While a cell phone is likely adequate for the investigators to see participants, it is not sufficiently large for them to see and follow exercise instruction.
Additionally, participants will need to have adequate space to both set up a computer/camera and move around. The minimal acceptable space for this is 6+ feet with an unobstructed view (from a table for instance) of a 2 x 2 open space. Participants will be coached to place the computer/camera/tablet/etc. at the position ~6 feet away and then stay within the 2x2 foot viewing area during exercise during the at-home zoom based testing (that occurs before the exercise sessions begin) Participants will be recruited so that they begin instruction in groups of 5 (i.e. the intervention will start as soon as 5 participants are recruited) and provided with 2 classes per week for 2 weeks where fundamental exercises are trained and reviewed. The following 2 weeks participants will continue to receive 1 small group class and will also be "added" to the large group class for 1 class per week. For the remaining three months of the intervention (12 weeks) participants will continue to engage in 2 large group classes per week.
Small group classes will be organized at the time of recruitment at 2x per week that matches the scheduling needs of all participants. This will, necessarily, be different for each recruited cohort.
Small group instruction: Five (5) participants will be paired with a master trainer (i.e. >1 year experience training in the zoom based environment and MS degree in exercise physiology, kinesiology, or athletic training) and a junior assistant. The master trainer will provide instruction and review participant performance while the junior assistant will provide support in terms of ensuring appropriate camera positioning (both for instructor and participant) and participant observation for signs of undue distress or difficulty.
Larger group instruction: After 2 weeks of small group instruction participants will be added to the growing group of individuals who have completed the small group instruction but not an additional 12 weeks. In concept this group could grow to infinite levels, but for the purposes of substudy 1 the largest the group could ever be is 15 individuals (the entire cohort). The larger group will also have a master trainer (i.e. >1 year experience training in the zoom based environment and MS degree in exercise physiology, kinesiology, or athletic training) and a junior assistant but will also be joined by a second junior trainer (BS or higher in exercise physiology, kinesiology, or athletic training or certification by a national recognized organization for personal training like ACSM, NASM, or ACE). One of the trainers will always be specifically monitoring participants to provide cues to ensure safety and maximize exercise benefits. The other trainer will both model exercises and provide feedback and the junior assistant will provide support in terms of ensuring appropriate camera positioning and providing participant observation.
All study participants will complete a clinic visit before they join the classes and after the last class to evaluate cardiorespiratory fitness, strength, balance and posture and answer questionnaires about quality of life and system usability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strong Survivors | Experimental | Other: 16 weeks remotely exercise program16 week, twice weekly, remote exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 16 weeks remotely exercise program16 weeks, twice per week, remotely exercise program | Other | Strong Survivors |
Primary outcome
Attendance
Time frame: 16 weeks
The number of sessions each participant attended (out of the total number of sessions offered) will be recorded and used to evaluate engagement in the tele-video real time exercise program in a geriatric breast cancer patient population. A participant is considered to have completed the study if he or she has completed all phases of the study including responding to follow up queries regarding falls for up to 1 year following the final measurement visit. Acceptability is based on attendance.
14 secondary outcomes
Cardiorespiratory Fitness: Time taken to reach 85% of age predicted heart rate max
Time frame: Before the beginning and at the end of the 16 weeks program
Strength and Balance
Time frame: Before the beginning and at the end of the 16 weeks program
Fall Risk assessment
Time frame: Before the beginning and at the end of the 16 weeks program
Balance
Time frame: Before the beginning and at the end of the 16 weeks program
Fall Risk
Time frame: Before the beginning and at the end of the 16 weeks program
Muscular Strength
Time frame: Before the beginning and at the end of the 16 weeks program
Posture
Time frame: Before the beginning and at the end of the 16 weeks program
Posture
Time frame: Before the beginning and at the end of the 16 weeks program
Posture
Time frame: Before the beginning and at the end of the 16 weeks program
Body Composition
Time frame: Before the beginning and at the end of the 16 weeks program
Physical Activity level
Time frame: Before the beginning and at the end of the 16 weeks program
Quality of Life assessment via PROMIS-29 questionnaire
Time frame: Before the beginning and at the end of the 16 weeks program
System Usability
Time frame: At the end of the 16 weeks program
Quality of life using FACT B questionnaire
Time frame: Before the beginning and at the end of the 16 weeks program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16 weeks remotely exercise program in people with Mastectomy, run by University of California, San Diego at 2 sites 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?
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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M. Grossi, MD (858.249.2764, smgrossi@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 16 weeks). 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 10 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.