Cancer Survival and Outcomes Impact of Universal Disability Screening and Cancer Rehabilitation Referral Among Adults With Cancer Referred to the University of North Carolina
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of rehabilitation interventions accepted
研究概览
简要总结
This pilot health services interventional study aims to prospectively assess the effectiveness of a pre-treatment rehabilitation (prehabilitation) program across a diverse cohort of adult cancer patients via a randomized pilot trial. Upon screening and identification of high-risk features through a central navigation process, patients referred to oncology clinics will be approached to participate in tailored prehabilitation interventions. The study will track and analyze functional outcomes and quality of life aiming to demonstrate the comprehensive benefits of prehabilitation on the cancer treatment continuum. We hypothesize that this referral program is feasible and that those randomized to the intervention arm will have superior functional outcomes and global health-related quality of life.
The rationale for this study is anchored in the urgent need to optimize the cancer care trajectory for high-risk patients whose treatment outcomes and quality of life are jeopardized by the multifaceted challenges of their disease. While prehabilitation has shown potential to mitigate these adverse effects, the optimal methods for identifying and connecting these high-risk individuals to appropriate prehabilitation resources remain underexplored. This study, with its systematic approach to enrolling a diverse adult cancer population, endeavors to investigate not only the benefits of prehabilitation interventions but also the effectiveness of a targeted referral process. By doing so, it aims to uncover novel strategies for efficiently allocating prehabilitation resources, thereby enhancing the precision and impact of supportive cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
- •Subjects are willing and able to comply with study procedures based on the judgement of the investigator.
- •Age ≥ 18 years at the time of consent.
- •The subject has been screened by the Central Oncology Navigation Program and referred to cancer care at the University of North Carolina Medical Center.
- •Answer "yes" to at least one of the following screening questions:
- •Does your health interfere with any of your activities of daily living (ADLs)?
- •Have you fallen, or do you feel unsteady while standing or walking?
- •Do you use durable medical equipment (DME)?
- •Are you interested in increasing the amount you exercise?
排除标准
- •Inability to read and understand the English language.
- •Psychological or other disability resulting in the inability to provide informed consent.
- •Unstable medical comorbidity that precludes safe participation in an exercise program, in the judgment of the clinical investigator.
- •Prisoners and other institutionalized individuals.
研究组 & 干预措施
Standard
Subjects will receive standard of care.
Rehabilitation
Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated.
干预措施: Rehabilitation-based intervention (Other)
结局指标
主要结局
The proportion of rehabilitation interventions accepted
时间窗: Baseline
The proportion of pre-treatment rehabilitation intervention performed for patients who are referred to cancer rehabilitation and attend an initial appointment.
次要结局
- Satisfaction rate(Baseline and post-3 months)
- Differences in physical function(Baseline and post-3 months)
- Differences in participant activation(Baseline and post-3 months)
- Differences in overall health(Baseline and post-3 months)
- Differences in physical activity levels(Baseline and post-3 months)
- Overall survival(Up to one year)