NCT07071896 A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors
| NCT ID | NCT07071896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Mastectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-01-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
In order to be eligible to participate in this study, an individual must meet all the following criteria: 1. Persons, aged 18+ 2. Undergone breast cancer surgery within the 4 weeks of being contacted for pre-screening a. Acceptable surgery includes unilateral or bilateral mastectomy (Lymph node surgery is NOT required but is still acceptable) 3. 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). 4. Provision of signed and dated informed consent form 5. 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: 1. Have sustained a previous fall-related fracture within the last 2 years; 2. 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 3. experience vertigo or dizziness/light headedness observed at enrollment or during initial occupational therapy evaluation. 4. are on multiple benzodiazepine or neuroleptic medications. 5. Pregnant or trying to become pregnant \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07071896 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Mastectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07071896 currently recruiting?
Yes, NCT07071896 is actively recruiting participants. Contact the research team at smgrossi@health.ucsd.edu for enrollment information.
Where is the NCT07071896 trial being conducted?
This trial is being conducted at San Diego, United States, San Diego, United States.
Who is sponsoring the NCT07071896 clinical trial?
NCT07071896 is sponsored by University of California, San Diego. The trial plans to enroll 15 participants.