A Pilot Feasibility Study of a Culturally Adapted Partnered Strength Training Intervention for Hispanic Cancer Survivors and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Feasibility measured by enrollment rate
研究概览
简要总结
The purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. The Exercising Together program is designed to promote teamwork during supervised group exercise classes delivered remotely through videoconferencing software. The intervention period will be 3-months with a 3-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria (Survivor only):
- •Self-identifies as Hispanic
- •Histologically confirmed prostate cancer diagnosis (self-report)
- •Completed primary treatment at least 6 weeks prior at time of enrollment
- •Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- •Inclusion Criteria (Caregivers):
- •1. Identifies as an individual (e.g., family member or friend) who provides unpaid care or support to a participating prostate cancer survivor.
- •Inclusion Criteria (Survivors and Caregivers):
- •≥18 years of age
- •Understands (ability to read and speak) English or Spanish and able to provide informed consent
- •Meets the American College of Sports Medicine pre-participation screening criteria for exercise
- •Ability to ambulate (with or without assistive devices)
- •Willing to attend study group exercise classes online, complete remote assessments, and answer online surveys
- •Has access to a mobile device with camera and internet.
- •Able to participate in classes at same time as other participating member.
排除标准
- •Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the Principal Investigator
- •A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise or poses a significant safety concern/risk for the well-being of the participant (e.g., declared pregnancy, poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, severe hearing or vision impairment)
- •Knowingly unable to attend >75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled
- •Incapable of providing informed consent, answering survey questions, participating in the intervention, and following directions during performance testing when English or Spanish language is used
- •Unable to be in the same location with participating member during remote exercise classes and performance testing and/or insufficient internet connectivity to support required videoconferencing software
- •Inclusion Criteria (Survivor only):
- •Histologically confirmed cancer diagnosis (self-report)
- •Completed primary treatment at least 6 weeks prior at time of enrollment
- •Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- •Inclusion Criteria for Caregivers remains the same as Phase 1 Exclusion Criteria remain the same as Phase 1
研究组 & 干预措施
Exercising Together
Dyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months.
干预措施: Exercising together (Behavioral)
结局指标
主要结局
Feasibility measured by enrollment rate
时间窗: 3 months
Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
Implementation Success - composite measure of acceptability, appropriateness, and feasibility.
时间窗: 3 months
Implementation success is a composite measure that will be measured by a single questionnaire that will determine the extent to which the intervention is considered acceptable, appropriate, and feasible. The single questionnaire will consist of 3 measures that will be summed into one final score, The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Responses from AIM, IAM, and FIM are summary scored with a possible range of 12-60; higher scores indicate greater acceptability, appropriateness, and feasibility.
Acceptability measured by adherence to intervention
时间窗: 3 months
Acceptability will be measured by adherence to the intervention calculated as the total number of classes attended divided by the total possible schedule the patient could attend using descriptive statistics.
Appropriateness measured by retention rate
时间窗: 3 months
Will be determined as the retention rate- calculated as the number of dyads completing the study versus consented using descriptive statistics.
次要结局
- Physical activity(Physical activity will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.)
- Health-Related Quality of Life (HR-QOL) for the caregiver(HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.)
- Health-Related Quality of Life (HR-QOL) for the survivor(HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.)
- Relationship Health(Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.)
- Objective Physical Function(Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.)