Strong Survivors: A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Attendance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •a. 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
排除标准
- •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.
- •Exclusion Criteria:
研究组 & 干预措施
Strong Survivors
16 week, twice weekly, remote exercise program
干预措施: 16 weeks remotely exercise program (Other)
结局指标
主要结局
Attendance
时间窗: 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.
次要结局
- Posture(Before the beginning and at the end of the 16 weeks program)
- System Usability(At the end of the 16 weeks program)
- 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)
- Muscular Strength(Before the beginning and at the end of the 16 weeks program)
- Body Composition(Before the beginning and at the end of the 16 weeks program)
- Physical Activity level(Before the beginning and at the end of the 16 weeks program)
- Quality of Life assessment via PROMIS-29 questionnaire(Before the beginning and at the end of the 16 weeks program)
- Quality of life using FACT B questionnaire(Before the beginning and at the end of the 16 weeks program)
研究者
Sara Grossi
Assistant Professor of Clinical Surgery, Breast Surgical Oncology, University of California San Diego Comprehensive Breast Health Center
University of California, San Diego