Strong Survivors: A Video-assisted Exercise Program for the Geriatric Breast Cancer Patient

NCT ID: NCT07071896

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2026-12-23

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Strong Survivors

16 week, twice weekly, remote exercise program

Group Type: EXPERIMENTAL

16 weeks remotely exercise program

Intervention Type: OTHER

16 weeks, twice per week, remotely exercise program

Interventions

16 weeks remotely exercise program

16 weeks, twice per week, remotely exercise program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 65+

2. Undergone mastectomy within the 4 weeks of being contacted for pre-screening

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

Exclusion Criteria

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.

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• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sara Grossi

Assistant Professor of Clinical Surgery, Breast Surgical Oncology, University of California San Diego Comprehensive Breast Health Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD

San Diego, California, United States

Site Status: NOT_YET_RECRUITING

UCSD

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara M. Grossi, MD

Role: CONTACT

smgrossi@health.ucsd.edu

858.249.2764

Shoshi Barkai, MS

Role: CONTACT

hbarkai@health.ucsd.edu

858-534-9315

Facility Contacts

Shoshi Barkai, MS

Role: primary

strongfoundations619@gmail.com

619-736-3450

Other Identifiers

809843

Identifier Type: -

Identifier Source: org_study_id