Rehabilitation Outcomes Study

NCT06674889 | Recruiting DMC

• 1 other identifier: LCCC2340
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (1)

• The proportion of rehabilitation interventions accepted

  The proportion of pre-treatment rehabilitation intervention performed for patients who are referred to cancer rehabilitation and attend an initial appointment.

  Baseline

Secondary Outcomes (6)

• 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

Study Arms (2)

Standard

NO INTERVENTION

Subjects will receive standard of care.

Rehabilitation

EXPERIMENTAL

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

Other: Rehabilitation-based intervention

Interventions

Rehabilitation-based intervention OTHER

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

Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

The N.C. Cancer Hospital

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christopher E Jensen, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devin McCarthy

CONTACT

919-966-4432; devin_mccarthy@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)