Rehabilitation Outcomes Study

NCT ID: NCT06674889

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2026-02-28

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.

Conditions

Cancer; Malignant Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard

Subjects will receive standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Rehabilitation

Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated.

Group Type: EXPERIMENTAL

Rehabilitation-based intervention

Intervention Type: OTHER

Assessment of the subject by a specialty consultation and exercise program development.

Interventions

Rehabilitation-based intervention

Assessment of the subject by a specialty consultation and exercise program development.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher E Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

The N.C. Cancer Hospital

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Devin McCarthy

Role: CONTACT

devin_mccarthy@med.unc.edu

919-966-4432

Facility Contacts

Onoshoze Bossey

Role: primary

onoshoze_bossey@med.unc.edu

919-962-7446

Christopher E Jensen, MD

Role: backup

christopher.jensen@unchealth.unc.edu

984-987-1072 ext. Jensen

Other Identifiers

LCCC2340

Identifier Type: -

Identifier Source: org_study_id