Rehabilitation Outcomes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rehabilitation-based intervention.
- Who it may be relevant to
- Registry conditions: Cancer, Malignant Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cancer Survival and Outcomes Impact of Universal Disability Screening and Cancer Rehabilitation Referral Among Adults With Cancer Referred to the University of North Carolina
Overview
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.
Interventions
- Other Rehabilitation-based intervention
Assessment of the subject by a specialty consultation and exercise program development.
Primary outcome measures
- The proportion of rehabilitation interventions accepted [Time frame: Baseline]
Secondary outcome measures (6)
- Satisfaction rate [Time frame: Baseline and post-3 months]
- Differences in physical function [Time frame: Baseline and post-3 months]
- Differences in participant activation [Time frame: Baseline and post-3 months]
- Differences in overall health [Time frame: Baseline and post-3 months]
- Differences in physical activity levels [Time frame: Baseline and post-3 months]
- Overall survival [Time frame: Up to one year]
Eligibility criteria
Inclusion criteria
- 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?
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The N.C. Cancer Hospital — Chapel Hill
Identifiers
NCT: NCT06674889 · LCCC2340