Clinical trial NCT06674889: Rehabilitation Outcomes Study
Official title: Feasibility and Outcomes of Universal Disability Screening and Cancer Rehabilitation Referral Among Adults With Cancer Referred to the University of North Carolina
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Malignant Tumor
Keywords: rehabilitation
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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:

  1. Does your health interfere with any of your activities of daily living (ADLs)?
  2. Have you fallen, or do you feel unsteady while standing or walking?
  3. Do you use durable medical equipment (DME)?
  4. 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.

Primary outcomes:
measure: The proportion of rehabilitation interventions accepted
timeFrame: Baseline
Secondary outcomes:
measure: Satisfaction rate
timeFrame: Baseline and post-3 months
measure: Differences in physical function
timeFrame: Baseline and post-3 months
measure: Differences in participant activation
timeFrame: Baseline and post-3 months
measure: Differences in overall health
timeFrame: Baseline and post-3 months
measure: Differences in physical activity levels
timeFrame: Baseline and post-3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The N.C. Cancer Hospital
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Christopher E Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: