A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors

NCT07071896 | Recruiting

• 1 other identifier: 809843
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Mastectomy

Keywords

Exercise, Mastectomy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (14)

• Cardiorespiratory Fitness: Time taken to reach 85% of age predicted heart rate max

  Before the beginning and at the end of the 16 weeks program

• Strength and Balance

  Before the beginning and at the end of the 16 weeks program

• Fall Risk assessment

  Before the beginning and at the end of the 16 weeks program

• Balance

  Before the beginning and at the end of the 16 weeks program

• Fall Risk

  Before the beginning and at the end of the 16 weeks program

Study Arms (1)

Strong Survivors

EXPERIMENTAL

16 week, twice weekly, remote exercise program

Other: 16 weeks remotely exercise program

Interventions

16 weeks remotely exercise program OTHER

16 weeks, twice per week, remotely exercise program

Strong Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

UCSD

San Diego, California, 92037, United States

NOT YET RECRUITING

UCSD

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Sara M. Grossi, MD

CONTACT

858.249.2764; smgrossi@health.ucsd.edu

Shoshi Barkai, MS

CONTACT

858-534-9315; hbarkai@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery, Breast Surgical Oncology, University of California San Diego Comprehensive Breast Health Center

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: July 17, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (2)